Parkinson DiseaseMFIPNCT04267107
Managing Fatigue in People With Parkinson's Disease
A study testing Individual Managing Fatigue Program in people with Parkinson Disease, run by Dalhousie University at 1 site in Canada.
Trial summary
This pilot study aims to evaluate the feasibility of Managing Fatigue: The Individual Program (MFIP) in people living with Parkinson's disease. The Managing Fatigue Program, a six-week, self-management energy conservation course, focuses on strategies that help people with fatigue to make changes to save and use their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Individual Managing Fatigue Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2020to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must:
- Be adults living in Nova Scotia,
- Self-report Parkinson's disease, and fatigue severe enough to interfere with daily life (measured by a score of ≥4 on the FSS).
- Read and speak in English
- Have access to the internet, an electronic device and a private place for Zoom videoconferences.
- Provide informed consent prior to participation.
Who cannot join
- People will be excluded from the study if :
- They have previously completed the study program (IMFP )
- They have co-morbidity that causes severe fatigue (e.g. heart failure, cancer)
- They indicate a severe cognitive deficit in the MMSE test ( MMSE <13).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Fatigue: The Individual Program in People Living With Parkinson's Disease- A Protocol for a Feasibility Study
This pilot study aims to evaluate the feasibility of Managing Fatigue: The Individual Program (MFIP) in people living with Parkinson's disease. The Managing Fatigue Program, a six-week, self-management energy conservation course, focuses on strategies that help people with fatigue to make changes to save and use their energy to accomplish their daily activities. Several studies have adapted and evaluated different delivery formats of the program in conditions similar to Parkinson's disease, demonstrating that the Managing Fatigue Program is effective in reducing fatigue impact, depression, sleep problems, and improving quality of life, participation and self-efficacy. While this program has been tested in people living with many chronic conditions there has been only limited inclusion of people living with PD. This feasibility study, using a mixed-methods approach, nested in a pilot randomized control design, will evaluate the feasibility of the Individual Managing Fatigue Program from the perspectives of people with Parkinson's disease, and prepare for a full-scale randomized controlled trial (RCT).
In this study, Managing Fatigue: The Individual Program (MFIP) will be delivered using videoconferencing. This feasibility study will use a mixed-methods approach, nested in a pilot two-armed randomized controlled design. Using a concurrent mixed-method design, we will collect two types of data (qualitative and quantitative) simultaneously, expanding our understanding of the feasibility of the program. Data will be collected using feasibility questionnaires developed by the research team, standard outcome measures, and group discussions. Multiple recruitment strategies will be used to recruit a convenience sample of 50 participants (25 in each group) from across the province of Nova Scotia, Canada. Eligible participants will be randomly assigned to either the control or experimental group using sealed envelopes. The study outcome measures will be administered three times during the study; pre-test, post-test after 6 weeks, and at three-month follow-up.
The results of this study will determine whether it is feasible to do a full-scale RCT in the future. If the known beneficial effects of the Managing Fatigue program extend to the PD population, this research will be the evidence needed to support the integration of this novel solution into the care of people with PD.
Read the detailed description
The aims of this study are to:
Aim 1. Evaluate the feasibility of the IMFP protocol in people living with PD. The sub-aims are to evaluate: (a) the relevance, acceptability, and perceived impact of the content of the MFIP from the perspective of recipients; and (b) the acceptability of the delivery logistics (technology, time, duration) of the MFIP from the perspective of individuals with PD.
Aim 2. Prepare for a full-scale RCT. The sub-aims are to (a) explore the preliminary effectiveness of the MFIP, (b) assess the suitability of the trial recruitment strategy based on the enrolment, completion and attrition rates, and variation in socio-demographic features of participants; (c) evaluate the suitability of potential outcome measures; and (d) use data arising from differences in the study outcomes between the MFIP and control arms to inform a power calculation for the sample size of a definitive RCT. As this study is a feasibility study, there is no primary versus secondary outcomes. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy.
Sample Size Calculation: As a pilot study, a power calculation is not strictly required. However, in preparation for the current study, investigators conducted both a sample size calculation and consulted previous literature to inform our estimation. To calculate the sample size, the type-1 error was set at 5% and the type-2 error was set at 20% for a power of 80%. Effect sizes were taken from available studies as follows: for the MFI, the effect size of -0.664 and for the COPM the effect size of 0.37. The results indicate that a total sample size of 42 participants will be required using the minimum effect size for the COPM. Estimating an attrition rate of 20%, a convenience sample of 50 participants (25 in each group) will be recruited from across the Halifax Regional Municipality (HRM), Canada.
This sample size selection aligns with recommendations for pilot studies by other researchers who have suggested that a minimum sample size of 24 to 50 is required for pilot feasibility studies. In another study by Hertzog (2008), a minimum sample of 10-25 people per group for feasibility studies is recommended.
Recruitment: Individuals for this study will be recruited in several different ways across the province of Nova Scotia. Investigators will recruit using 1) web-based advertisements on the International Chronic and Complex Conditions Research Group website and KIJIJI, 2) posters at the Parkinson's Society Maritime Region office 3) social media (Twitter, Facebook), 4) public TV advertising and 5) word of mouth. Individuals who are interested in participating in the study will contact the research team.
Individuals who are interested in participating will be invited to contact the research team by email. Potential participants will first undergo an email screening procedure to confirm preliminary eligibility criteria. Once eligibility is confirmed they will be sent study information and a consent form by email. Final eligibility will be confirmed after completion of the FSS and the MMSE during a videoconference call. Consent will be ascertained and confirmed verbally prior to any data collection. Participants will be informed that they may withdraw from the study at any time and for any reason. The assessor for all screening and data collection will be blind to group allocation.
Data Collection-Aim 1: This aim will be achieved using data collected from only the experimental group.
Registered occupational therapists will deliver the IMFP. Therapists graduate with the knowledge and skills to treat people with neurological conditions. All therapists will be required to successfully complete an online training session prior to participation. They will learn about the MFIP and the current evidence-based guidelines and research about working with individuals with PD.
The therapists will be instructed to report to the study supervisor and the principal researcher if there are any safety complications during the sessions.
Feasibility Questionnaires (experimental group only): Two feasibility questionnaires, based on the purposes of the study and the program's intentions, will be administered to participants. Questionnaire # 1 will evaluate the relevance, acceptability, and usability of each session. Participants will complete these, online, after each weekly session. Questionnaire #2 will evaluate the relevance, acceptability, usability, and logistical aspects of the whole program. It will be administered once, at the completion of the program. The responses on the feasibility questionnaires use a five-point Likert scale (Likert, 1932) (0 = 'strongly disagree' to 4 = 'strongly agree). A research assistant, independent from other parts of the study, will send the individualized links for each questionnaire to participants by email. Data collected on the Feasibility Questionnaires will be cleaned and analyzed at the completion of all data collection. This will ensure that this researcher remains masked to group allocation during the study data collection.
Focus Groups: After completion of the program, 15 participants will be recruited to participate in one of three focus groups (n=5) using maximum variation sampling based on disease duration, fatigue severity, and gender. Participants will provide separate consent prior to participating. An experienced, independent research assistant will conduct the focus groups via videoconference using a prepared interview guide. Participants will be encouraged to discuss the feasibility of the program (relevance, usability, acceptability, and logistics), barriers to completion of the program, acceptability of study measures, and any perceived impact/changes (improvements/adverse events).
Data collection - Aim 2: To evaluate the preliminary effectiveness of MFIP in people living with PD and the feasibility of potential outcome measures a collection of patient-reported outcome measures will be used. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy. Effectiveness data will also be used to inform the power calculation for a definitive trial. The study outcome measures will be administered at baseline, at post-intervention and at three months following completion of the program.
The principal researcher, who will be masked to group allocation, will be responsible for administering all the study outcome measures online using the Opinio Survey Software Application while videoconferencing with the researcher.
Data Analysis: All quantitative data in this study will be analysed using STATA software (release 15 for Windows). After data entry, data will be examined for skewness, outliers, and systematic missing data. Extreme outliers, defined as greater than ±2SD from the mean will be removed from the data if they are less than 5% of all data (Allison, 2001)
Data from the feasibility questionnaires will be analyzed using descriptive analysis, including frequencies and proportions for categorical data (e.g. demographic data), and means, and standard deviations for continuous data (e.g. questionnaires).
Using general linear mixed model analysis, the preliminary effectiveness of the program will be determined. This analysis method will account for missing data at the measurement level. Also, in this study, we do not expect missing data at the item-level as all the measurements are completed with the supervision of the principal researcher. If there are missing data, they will be managed using the required steps based on the protocol of each measurement tool. If the maximum number of missing items has not been included in the protocol of measurements it will be set at 20%. If the scoring algorithm does not provide for missing data, values will be imputed using mean substitution.
Using calculated effect sizes, this study will 1) estimate the preliminary effectiveness and the required sample size for future RCTs, and 2) evaluate the sensitivity and responsiveness of the study outcome measures. Measurement tools with the highest effect size and the smallest significance level are the most sensitive measures to change due to the intervention (Corzillius, Fortin, \& Stucki, 1999. In regard to the responsiveness of measures, measurement tools that have higher levels of variability in participants at baseline, in relation to mean change scores, will have a smaller effect and therefore, are less responsive (Husted, Cook, Farewell, \& Gladman, 2000. Qualitative data obtained from participants in focus group, together with the quantitative data will be used to recommend outcome measures for the future RCT.
The efficiency of the recruitment strategies will be examined using data from the number of individuals who contact the research team, the number of participants who meet the study criteria, the number who withdraw from the study or are lost to follow-up (attrition rates), and the variation in sociodemographic characteristics of the participants.
Focus groups will be audiotaped and transcribed verbatim. Any potentially identifying information will be removed prior to analysis. Data will be analyzed using the six-stage content analysis framework by Braun and Clarke (2014). Data will be managed using the NVIVO qualitative data analysis software (QSR International Pty Ltd., Version 11, 2015). The text will be coded without any changes in meaning. Coded material will be categorized semantically until themes emerge. Codes and themes will be reviewed and refined until the final distinctive themes can be created (Bob-Milliar, 2014).
- Conditions
- Parkinson Disease
- Being tested
- Individual Managing Fatigue Program
- Keywords
- Parkinsons disease, Self-management, Fatigue management, Occupational therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Managing Fatigue ProgramOther
Also called Energy conservation, Self-management, Occupational therapy
The Individual Managing Fatigue Program includes six weekly sessions that focus on sleep, communication and body mechanics, activity stations, priorities and standards, and balancing daily schedule. Each session includes three parts: 1) a pre-session activity 2) in-session activities/information and 3) homework. Prior to coming to each session, participants will be asked to complete activities that will help them prepare for the in-session discussions. During each session participants will discuss and practice the topics most important to them. Based on their discussions, participants and therapists will decide on activities to complete during each session and as homework. The therapist will help the participant begin the homework at the end of each session, and the participant will finish it outside of the session at home. At the beginning of the following session, the therapist and participant will review the homework.
| Study group | Role | What they receive |
|---|---|---|
| Managing Fatigue:The Individual Program | Experimental | Participants in the experimental group will receive the 6-week MFIP. Individuals in experimental group :
* will participate in six one-to-one sessions (each takes 60 to 90 minutes)
* will complete the Feasibility Questionnaire #1, after each session (10 questions) (Appendix 6)
* will complete Feasibility Questionnaire #2 after completing all six-sessions (12 questions) (Appendix 7)
* will complete the post-test measurement after completion of the program (approximately 60 minutes to complete)
* will complete the follow-up measurement, three months after the completion of the program (approximately 60 minutes to complete)
* will be advised to continue with their current healthcare services.
* may participate in one focus group (one-hour session) Receives: Other: Individual Managing Fatigue Program |
| Control Group | No intervention | Participants in the control group will not receive the IMFP and they will be advised to continue with their current healthcare services. Participants in the control group: * will complete post-test measurements after 6 weeks (approximately 60 minutes), * will complete the follow-up measurements three months later after completing the program (approximately 60 minutes). * will be advised to continue with their current healthcare services. Following the study, participants in the control group will be offered the manual of the program and a three-hour training workshop after (three months after the baseline testing). In this workshop, they will learn about the about the program, including the pre-session activities, in-session activities, and homework. This workshop will be conducted by occupational therapists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Fatigue Inventory (MFI)
Fatigue impact will be measured with the Multidimensional Fatigue Inventory (MFI) (Smets et al., 1995). The MFI is a self-report fatigue tool with 20 items measuring five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motion, and Reduced Activity. Elbers and colleagues (2012) evaluated the MFI in the PD population (N=153). After combining General Fatigue and Physical Fatigue dimensions they reported the reliability and validity of the four-domain scale (Physical Fatigue, Mental Fatigue, Reduced Motivation, and reduced activity) as higher than the original five-domain scale. Testing of the MFI shows good internal consistency (Cronbach's alpha >0.80) and construct validity compared to a Visual Analogue Scale measuring fatigue (0.22<r<0.78) (Smets et al., 1995).
Measured: Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.
Occupational Balance Questionnaire
Occupational balance will be measured with the Occupational Balance Questionnaire (OBQ) (Wagman \& Håkansson, 2014). The OBQ is an 11-item measure developed by Wagman et al., (2014), which assesses individuals' satisfaction and perception with the amount and variation of meaningful occupations. The OBQ measures satisfaction with the amount of time that one takes to accomplish tasks. It uses a 4-level ordinal response scale for each item ranging from 0 "completely disagree" to 3 "completely agree". The OBQ total score ranges from 0 (no occupational balance) to 35 (maximum occupational balance). The psychometric properties of the OBQ have not been explored in PD. However, in the general population, it has shown good internal consistency (Cronbach's alpha= 0.936) and test, re-test reliability (Spearman's Rho= 0.926) for its total score (N=67). Neither ceiling nor floor effects were reported (Håkansson, Wagman, \& Hagell, 2019).
Measured: Changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.
Canadian Occupational Performance Measure
Occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998). The COPM was selected since it has proven to be sensitive to change and was able to detect significant differences between study groups at three months (mean difference =1.2 (95% CI 0.8-1.6) and after 6 months follow-up (mean differences= 0.9 ( 95%CI 0.5-1.3) (I. Sturkenboom et al., 2013). The COPM is a client-centred, standardized, cost-effective, occupation-focused measure used in occupational therapy. It is an individualized outcome measure administered using a semi-structured interview. It measures occupational performance and occupational satisfaction (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998).
Measured: Changes from baseline occupational performance to six weeks later, at post-test, and after a three-month follow up.
Parkinson's Disease Quality of Life-8 (PDQ-8)
Quality of life will be measured with the Parkinson's Disease Quality of Life-8 (PDQ-8) (Tan et al., 2004). The PDQ-8 is a short-form version of the Parkinson Disease Questionaire-39 which assesses the impact of PD on HRQoL over the past month. The PDQ-8 is a summary index with eight items, each representing one dimension of the PDQ-39 (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). It uses a 0-4 response scale. Scores are summed, then converted into a percentage. Lower scores indicate better quality of life (Peto et al., 1995). The PDQ-8 psychometric properties have been confirmed in several studies (Franchignoni, Giordano, \& Ferriero, 2008; Katsarou et al., 2004; Luo et al., 2009; Tan, Luo, Nazri, Li, \& Thumboo, 2004). Franchignon et al (2008) and Tan et al (2004) demonstrated good internal consistency (Cronbach's alpha 0.72, 0.81) and construct validity between PDQ-8 and a measure of autonomy and
Measured: Changes from baseline quality of life to six weeks later, at post-test, and after a three-month follow up.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989). PSQI is the most common assessment tool used to evaluate sleep quality (Mollayeva et al., 2016). It is a 19-item self-report assessment that measures seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). Component scores range from 0 (no difficulty) to 3 (severe difficulty) and are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A meta-analysis by Mollayeva et al. (2016) evaluated the measurement properties of the PSQI. This meta-analysis (N=37) demonstrated that the PSQI has good internal consistency based on Cronbach's alpha, strong reliability and validity, and moderate structural validity in a variety of samples. The PSQI has been used as an outcome measure to test the effectiveness
Measured: Changes from baseline sleep quality to six weeks later, at post-test, and after a three-month follow up.
Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
The Self-efficacy will be measured by the Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA) (Liepold \& Mathiowetz, 2005). The SEPECSA was developed based on the Managing Fatigue Program (Liepold \& Mathiowetz, 2005) and measures the individual's self-confidence to perform the strategies they learned in the program. The item response scale of the SEPECSA ranges from 1 (not at all confident) to 10 (completely confident). The final score is mean of the item scores. In a study of individuals with MS (N=36), Liepold \& Mathiowetz (2005) demonstrated that the SEPECSA has high test and retest reliability (r = .776, ICC = .771), good validity, and very high internal consistency (Cronbach's alpha = .953). The SPECSA has not been used with the PD population, however, it has been used in previous similar studies (Ghahari et al., 2010; Matuska, Mathiowetz, \& Finlayson, 2007).
Measured: Changes from baseline self-efficacy to six weeks later, at post-test, and after a three-month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start2 Nov 2020
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This feasibility study will use a mixed-methods approach, nested in a pilot 2-arm randomized control design (experimental and no intervention control). We will collect qualitative and quantitative data simultaneously which will expand our understanding of the feasibility of the program.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Packer, Dalhousie University
- Investigators
- Tanya Packer, PhD, Study director, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267107
- Sponsor's protocol ID
- 2019-4954
- Acronym
- MFIP
- Status last verified
- Sep 2023
- First submitted
- 6 Feb 2020
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amara AW, Memon AA. Effects of Exercise on Non-motor Symptoms in Parkinson's Disease. Clin Ther. 2018 Jan;40(1):8-15. doi: 10.1016/j.clinthera.2017.11.004. Epub 2017 Dec 1.
PubMed 29198450Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
PubMed 847061Beckerman H, Blikman LJ, Heine M, Malekzadeh A, Teunissen CE, Bussmann JB, Kwakkel G, van Meeteren J, de Groot V; TREFAMS-ACE study group. The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme. Trials. 2013 Aug 12;14:250. doi: 10.1186/1745-6215-14-250.
PubMed 23938046Beiske AG, Svensson E. Fatigue in Parkinson's disease: a short update. Acta Neurol Scand Suppl. 2010;(190):78-81. doi: 10.1111/j.1600-0404.2010.01381.x.
PubMed 20586741Bivard A, Lillicrap T, Krishnamurthy V, Holliday E, Attia J, Pagram H, Nilsson M, Parsons M, Levi CR. MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial. Stroke. 2017 May;48(5):1293-1298. doi: 10.1161/STROKEAHA.116.016293. Epub 2017 Apr 12.
PubMed 28404841Blikman LJ, Huisstede BM, Kooijmans H, Stam HJ, Bussmann JB, van Meeteren J. Effectiveness of energy conservation treatment in reducing fatigue in multiple sclerosis: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2013 Jul;94(7):1360-76. doi: 10.1016/j.apmr.2013.01.025. Epub 2013 Feb 8.
PubMed 23399455Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Chaudhuri A, Behan PO. Fatigue in neurological disorders. Lancet. 2004 Mar 20;363(9413):978-88. doi: 10.1016/S0140-6736(04)15794-2.
PubMed 15043967Corzillius M, Fortin P, Stucki G. Responsiveness and sensitivity to change of SLE disease activity measures. Lupus. 1999;8(8):655-9. doi: 10.1191/096120399680411416.
PubMed 10568903Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23.
PubMed 24279835Cup EH, Scholte op Reimer WJ, Thijssen MC, van Kuyk-Minis MA. Reliability and validity of the Canadian Occupational Performance Measure in stroke patients. Clin Rehabil. 2003 Jul;17(4):402-9. doi: 10.1191/0269215503cr635oa.
PubMed 12785249Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004 Sep;18(6):660-7. doi: 10.1191/0269215504cr746oa.
PubMed 15473118DeLuca J, Genova HM, Capili EJ, Wylie GR. Functional neuroimaging of fatigue. Phys Med Rehabil Clin N Am. 2009 May;20(2):325-37. doi: 10.1016/j.pmr.2008.12.007.
PubMed 19389614Elbers RG, Berendse HW, Kwakkel G. Treatment of Fatigue in Parkinson Disease. JAMA. 2016 Jun 7;315(21):2340-1. doi: 10.1001/jama.2016.5260.
PubMed 27272586Elbers RG, van Wegen EE, Verhoef J, Kwakkel G. Reliability and structural validity of the Multidimensional Fatigue Inventory (MFI) in patients with idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2012 Jun;18(5):532-6. doi: 10.1016/j.parkreldis.2012.01.024. Epub 2012 Feb 22.
PubMed 22361576
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Fatigue: The Individual Program in People Living With Parkinson's Disease- A Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT04267107
- Acronym / sponsor ID
- MFIP / 2019-4954
- Conditions
- Parkinson Disease
- Keywords
- Parkinsons disease, Self-management, Fatigue management, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to evaluate the feasibility of Managing Fatigue: The Individual Program (MFIP) in people living with Parkinson's disease. The Managing Fatigue Program, a six-week, self-management energy conservation course, focuses on strategies that help people with fatigue to make changes to save and use their energy to accomplish their daily activities. Several studies have adapted and evaluated different delivery formats of the program in conditions similar to Parkinson's disease, demonstrating that the Managing Fatigue Program is effective in reducing fatigue impact, depression, sleep problems, and improving quality of life, participation and self-efficacy. While this program has been tested in people living with many chronic conditions there has been only limited inclusion of people living with PD. This feasibility study, using a mixed-methods approach, nested in a pilot randomized control design, will evaluate the feasibility of the Individual Managing Fatigue Program from the perspectives of people with Parkinson's disease, and prepare for a full-scale randomized controlled trial (RCT).
In this study, Managing Fatigue: The Individual Program (MFIP) will be delivered using videoconferencing. This feasibility study will use a mixed-methods approach, nested in a pilot two-armed randomized controlled design. Using a concurrent mixed-method design, we will collect two types of data (qualitative and quantitative) simultaneously, expanding our understanding of the feasibility of the program. Data will be collected using feasibility questionnaires developed by the research team, standard outcome measures, and group discussions. Multiple recruitment strategies will be used to recruit a convenience sample of 50 participants (25 in each group) from across the province of Nova Scotia, Canada. Eligible participants will be randomly assigned to either the control or experimental group using sealed envelopes. The study outcome measures will be administered three times during the study; pre-test, post-test after 6 weeks, and at three-month follow-up.
The results of this study will determine whether it is feasible to do a full-scale RCT in the future. If the known beneficial effects of the Managing Fatigue program extend to the PD population, this research will be the evidence needed to support the integration of this novel solution into the care of people with PD.
Detailed description
The aims of this study are to:
Aim 1. Evaluate the feasibility of the IMFP protocol in people living with PD. The sub-aims are to evaluate: (a) the relevance, acceptability, and perceived impact of the content of the MFIP from the perspective of recipients; and (b) the acceptability of the delivery logistics (technology, time, duration) of the MFIP from the perspective of individuals with PD.
Aim 2. Prepare for a full-scale RCT. The sub-aims are to (a) explore the preliminary effectiveness of the MFIP, (b) assess the suitability of the trial recruitment strategy based on the enrolment, completion and attrition rates, and variation in socio-demographic features of participants; (c) evaluate the suitability of potential outcome measures; and (d) use data arising from differences in the study outcomes between the MFIP and control arms to inform a power calculation for the sample size of a definitive RCT. As this study is a feasibility study, there is no primary versus secondary outcomes. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy.
Sample Size Calculation: As a pilot study, a power calculation is not strictly required. However, in preparation for the current study, investigators conducted both a sample size calculation and consulted previous literature to inform our estimation. To calculate the sample size, the type-1 error was set at 5% and the type-2 error was set at 20% for a power of 80%. Effect sizes were taken from available studies as follows: for the MFI, the effect size of -0.664 and for the COPM the effect size of 0.37. The results indicate that a total sample size of 42 participants will be required using the minimum effect size for the COPM. Estimating an attrition rate of 20%, a convenience sample of 50 participants (25 in each group) will be recruited from across the Halifax Regional Municipality (HRM), Canada.
This sample size selection aligns with recommendations for pilot studies by other researchers who have suggested that a minimum sample size of 24 to 50 is required for pilot feasibility studies. In another study by Hertzog (2008), a minimum sample of 10-25 people per group for feasibility studies is recommended.
Recruitment: Individuals for this study will be recruited in several different ways across the province of Nova Scotia. Investigators will recruit using 1) web-based advertisements on the International Chronic and Complex Conditions Research Group website and KIJIJI, 2) posters at the Parkinson's Society Maritime Region office 3) social media (Twitter, Facebook), 4) public TV advertising and 5) word of mouth. Individuals who are interested in participating in the study will contact the research team.
Individuals who are interested in participating will be invited to contact the research team by email. Potential participants will first undergo an email screening procedure to confirm preliminary eligibility criteria. Once eligibility is confirmed they will be sent study information and a consent form by email. Final eligibility will be confirmed after completion of the FSS and the MMSE during a videoconference call. Consent will be ascertained and confirmed verbally prior to any data collection. Participants will be informed that they may withdraw from the study at any time and for any reason. The assessor for all screening and data collection will be blind to group allocation.
Data Collection-Aim 1: This aim will be achieved using data collected from only the experimental group.
Registered occupational therapists will deliver the IMFP. Therapists graduate with the knowledge and skills to treat people with neurological conditions. All therapists will be required to successfully complete an online training session prior to participation. They will learn about the MFIP and the current evidence-based guidelines and research about working with individuals with PD.
The therapists will be instructed to report to the study supervisor and the principal researcher if there are any safety complications during the sessions.
Feasibility Questionnaires (experimental group only): Two feasibility questionnaires, based on the purposes of the study and the program's intentions, will be administered to participants. Questionnaire # 1 will evaluate the relevance, acceptability, and usability of each session. Participants will complete these, online, after each weekly session. Questionnaire #2 will evaluate the relevance, acceptability, usability, and logistical aspects of the whole program. It will be administered once, at the completion of the program. The responses on the feasibility questionnaires use a five-point Likert scale (Likert, 1932) (0 = 'strongly disagree' to 4 = 'strongly agree). A research assistant, independent from other parts of the study, will send the individualized links for each questionnaire to participants by email. Data collected on the Feasibility Questionnaires will be cleaned and analyzed at the completion of all data collection. This will ensure that this researcher remains masked to group allocation during the study data collection.
Focus Groups: After completion of the program, 15 participants will be recruited to participate in one of three focus groups (n=5) using maximum variation sampling based on disease duration, fatigue severity, and gender. Participants will provide separate consent prior to participating. An experienced, independent research assistant will conduct the focus groups via videoconference using a prepared interview guide. Participants will be encouraged to discuss the feasibility of the program (relevance, usability, acceptability, and logistics), barriers to completion of the program, acceptability of study measures, and any perceived impact/changes (improvements/adverse events).
Data collection - Aim 2: To evaluate the preliminary effectiveness of MFIP in people living with PD and the feasibility of potential outcome measures a collection of patient-reported outcome measures will be used. The outcomes for this study are occupational performance, occupational balance, fatigue impact, quality of life, sleep quality and self-efficacy. Effectiveness data will also be used to inform the power calculation for a definitive trial. The study outcome measures will be administered at baseline, at post-intervention and at three months following completion of the program.
The principal researcher, who will be masked to group allocation, will be responsible for administering all the study outcome measures online using the Opinio Survey Software Application while videoconferencing with the researcher.
Data Analysis: All quantitative data in this study will be analysed using STATA software (release 15 for Windows). After data entry, data will be examined for skewness, outliers, and systematic missing data. Extreme outliers, defined as greater than ±2SD from the mean will be removed from the data if they are less than 5% of all data (Allison, 2001)
Data from the feasibility questionnaires will be analyzed using descriptive analysis, including frequencies and proportions for categorical data (e.g. demographic data), and means, and standard deviations for continuous data (e.g. questionnaires).
Using general linear mixed model analysis, the preliminary effectiveness of the program will be determined. This analysis method will account for missing data at the measurement level. Also, in this study, we do not expect missing data at the item-level as all the measurements are completed with the supervision of the principal researcher. If there are missing data, they will be managed using the required steps based on the protocol of each measurement tool. If the maximum number of missing items has not been included in the protocol of measurements it will be set at 20%. If the scoring algorithm does not provide for missing data, values will be imputed using mean substitution.
Using calculated effect sizes, this study will 1) estimate the preliminary effectiveness and the required sample size for future RCTs, and 2) evaluate the sensitivity and responsiveness of the study outcome measures. Measurement tools with the highest effect size and the smallest significance level are the most sensitive measures to change due to the intervention (Corzillius, Fortin, \& Stucki, 1999. In regard to the responsiveness of measures, measurement tools that have higher levels of variability in participants at baseline, in relation to mean change scores, will have a smaller effect and therefore, are less responsive (Husted, Cook, Farewell, \& Gladman, 2000. Qualitative data obtained from participants in focus group, together with the quantitative data will be used to recommend outcome measures for the future RCT.
The efficiency of the recruitment strategies will be examined using data from the number of individuals who contact the research team, the number of participants who meet the study criteria, the number who withdraw from the study or are lost to follow-up (attrition rates), and the variation in sociodemographic characteristics of the participants.
Focus groups will be audiotaped and transcribed verbatim. Any potentially identifying information will be removed prior to analysis. Data will be analyzed using the six-stage content analysis framework by Braun and Clarke (2014). Data will be managed using the NVIVO qualitative data analysis software (QSR International Pty Ltd., Version 11, 2015). The text will be coded without any changes in meaning. Coded material will be categorized semantically until themes emerge. Codes and themes will be reviewed and refined until the final distinctive themes can be created (Bob-Milliar, 2014).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This feasibility study will use a mixed-methods approach, nested in a pilot 2-arm randomized control design (experimental and no intervention control). We will collect qualitative and quantitative data simultaneously which will expand our understanding of the feasibility of the program.
| Arm | Type | Receives |
|---|---|---|
| Managing Fatigue:The Individual Program | Experimental | Other: Individual Managing Fatigue ProgramParticipants in the experimental group will receive the 6-week MFIP. Individuals in experimental group : * will participate in six one-to-one sessions (each takes 60 to 90 minutes) * will complete the Feasibility Questionnaire #1, after each session (10 questions) (Appendix 6) * will complete Feasibility Questionnaire #2 after completing all six-sessions (12 questions) (Appendix 7) * will complete the post-test measurement after completion of the program (approximately 60 minutes to complete) * will complete the follow-up measurement, three months after the completion of the program (approximately 60 minutes to complete) * will be advised to continue with their current healthcare services. * may participate in one focus group (one-hour session) |
| Control Group | No intervention | –Participants in the control group will not receive the IMFP and they will be advised to continue with their current healthcare services. Participants in the control group: * will complete post-test measurements after 6 weeks (approximately 60 minutes), * will complete the follow-up measurements three months later after completing the program (approximately 60 minutes). * will be advised to continue with their current healthcare services. Following the study, participants in the control group will be offered the manual of the program and a three-hour training workshop after (three months after the baseline testing). In this workshop, they will learn about the about the program, including the pre-session activities, in-session activities, and homework. This workshop will be conducted by occupational therapists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be adults living in Nova Scotia,
- Self-report Parkinson's disease, and fatigue severe enough to interfere with daily life (measured by a score of ≥4 on the FSS).
- Read and speak in English
- Have access to the internet, an electronic device and a private place for Zoom videoconferences.
- Provide informed consent prior to participation.
Key exclusion criteria (4 listed)
- They have previously completed the study program (IMFP )
- They have co-morbidity that causes severe fatigue (e.g. heart failure, cancer)
- They indicate a severe cognitive deficit in the MMSE test ( MMSE <13).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Managing Fatigue ProgramAlso: Energy conservation, Self-management, Occupational therapyThe Individual Managing Fatigue Program includes six weekly sessions that focus on sleep, communication and body mechanics, activity stations, priorities and standards, and balancing daily schedule. Each session includes three parts: 1) a pre-session activity 2) in-session activities/information and 3) homework. Prior to coming to each session, participants will be asked to complete activities that will help them prepare for the in-session discussions. During each session participants will discuss and practice the topics most important to them. Based on their discussions, participants and therapists will decide on activities to complete during each session and as homework. The therapist will help the participant begin the homework at the end of each session, and the participant will finish it outside of the session at home. At the beginning of the following session, the therapist and participant will review the homework. | Other | Managing Fatigue:The Individual Program |
Primary outcome
Multidimensional Fatigue Inventory (MFI)
Time frame: Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.
Fatigue impact will be measured with the Multidimensional Fatigue Inventory (MFI) (Smets et al., 1995). The MFI is a self-report fatigue tool with 20 items measuring five dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motion, and Reduced Activity. Elbers and colleagues (2012) evaluated the MFI in the PD population (N=153). After combining General Fatigue and Physical Fatigue dimensions they reported the reliability and validity of the four-domain scale (Physical Fatigue, Mental Fatigue, Reduced Motivation, and reduced activity) as higher than the original five-domain scale. Testing of the MFI shows good internal consistency (Cronbach's alpha >0.80) and construct validity compared to a Visual Analogue Scale measuring fatigue (0.22<r<0.78) (Smets et al., 1995).
Occupational Balance Questionnaire
Time frame: Changes from baseline occupational balance to six weeks later, at post-test, and after a three-month follow up.
Occupational balance will be measured with the Occupational Balance Questionnaire (OBQ) (Wagman \& Håkansson, 2014). The OBQ is an 11-item measure developed by Wagman et al., (2014), which assesses individuals' satisfaction and perception with the amount and variation of meaningful occupations. The OBQ measures satisfaction with the amount of time that one takes to accomplish tasks. It uses a 4-level ordinal response scale for each item ranging from 0 "completely disagree" to 3 "completely agree". The OBQ total score ranges from 0 (no occupational balance) to 35 (maximum occupational balance). The psychometric properties of the OBQ have not been explored in PD. However, in the general population, it has shown good internal consistency (Cronbach's alpha= 0.936) and test, re-test reliability (Spearman's Rho= 0.926) for its total score (N=67). Neither ceiling nor floor effects were reported (Håkansson, Wagman, \& Hagell, 2019).
Canadian Occupational Performance Measure
Time frame: Changes from baseline occupational performance to six weeks later, at post-test, and after a three-month follow up.
Occupational performance will be measured with the Canadian Occupational Performance Measure (COPM) (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998). The COPM was selected since it has proven to be sensitive to change and was able to detect significant differences between study groups at three months (mean difference =1.2 (95% CI 0.8-1.6) and after 6 months follow-up (mean differences= 0.9 ( 95%CI 0.5-1.3) (I. Sturkenboom et al., 2013). The COPM is a client-centred, standardized, cost-effective, occupation-focused measure used in occupational therapy. It is an individualized outcome measure administered using a semi-structured interview. It measures occupational performance and occupational satisfaction (Law, M. Baptiste, S., Carswell, A. McColl, M. A., Polatajko, H. \& Pollock, 1998).
Parkinson's Disease Quality of Life-8 (PDQ-8)
Time frame: Changes from baseline quality of life to six weeks later, at post-test, and after a three-month follow up.
Quality of life will be measured with the Parkinson's Disease Quality of Life-8 (PDQ-8) (Tan et al., 2004). The PDQ-8 is a short-form version of the Parkinson Disease Questionaire-39 which assesses the impact of PD on HRQoL over the past month. The PDQ-8 is a summary index with eight items, each representing one dimension of the PDQ-39 (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). It uses a 0-4 response scale. Scores are summed, then converted into a percentage. Lower scores indicate better quality of life (Peto et al., 1995). The PDQ-8 psychometric properties have been confirmed in several studies (Franchignoni, Giordano, \& Ferriero, 2008; Katsarou et al., 2004; Luo et al., 2009; Tan, Luo, Nazri, Li, \& Thumboo, 2004). Franchignon et al (2008) and Tan et al (2004) demonstrated good internal consistency (Cronbach's alpha 0.72, 0.81) and construct validity between PDQ-8 and a measure of autonomy and
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Changes from baseline sleep quality to six weeks later, at post-test, and after a three-month follow up.
Sleep quality will be measured with the Pittsburgh Sleep Quality Index (PSQI) (Buysse et al., 1989). PSQI is the most common assessment tool used to evaluate sleep quality (Mollayeva et al., 2016). It is a 19-item self-report assessment that measures seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction (Buysse, Reynolds, Monk, Berman, \& Kupfer, 1989). Component scores range from 0 (no difficulty) to 3 (severe difficulty) and are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. A meta-analysis by Mollayeva et al. (2016) evaluated the measurement properties of the PSQI. This meta-analysis (N=37) demonstrated that the PSQI has good internal consistency based on Cronbach's alpha, strong reliability and validity, and moderate structural validity in a variety of samples. The PSQI has been used as an outcome measure to test the effectiveness
Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)
Time frame: Changes from baseline self-efficacy to six weeks later, at post-test, and after a three-month follow up.
The Self-efficacy will be measured by the Self Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA) (Liepold \& Mathiowetz, 2005). The SEPECSA was developed based on the Managing Fatigue Program (Liepold \& Mathiowetz, 2005) and measures the individual's self-confidence to perform the strategies they learned in the program. The item response scale of the SEPECSA ranges from 1 (not at all confident) to 10 (completely confident). The final score is mean of the item scores. In a study of individuals with MS (N=36), Liepold \& Mathiowetz (2005) demonstrated that the SEPECSA has high test and retest reliability (r = .776, ICC = .771), good validity, and very high internal consistency (Cronbach's alpha = .953). The SPECSA has not been used with the PD population, however, it has been used in previous similar studies (Ghahari et al., 2010; Matuska, Mathiowetz, \& Finlayson, 2007).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 29198450Amara AW, Memon AA. Effects of Exercise on Non-motor Symptoms in Parkinson's Disease. Clin Ther. 2018 Jan;40(1):8-15. doi: 10.1016/j.clinthera.2017.11.004. Epub 2017 Dec 1.
- Background: PubMed 847061Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.
- Background: PubMed 23938046Beckerman H, Blikman LJ, Heine M, Malekzadeh A, Teunissen CE, Bussmann JB, Kwakkel G, van Meeteren J, de Groot V; TREFAMS-ACE study group. The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme. Trials. 2013 Aug 12;14:250. doi: 10.1186/1745-6215-14-250.
- Background: PubMed 20586741Beiske AG, Svensson E. Fatigue in Parkinson's disease: a short update. Acta Neurol Scand Suppl. 2010;(190):78-81. doi: 10.1111/j.1600-0404.2010.01381.x.
- Background: PubMed 28404841Bivard A, Lillicrap T, Krishnamurthy V, Holliday E, Attia J, Pagram H, Nilsson M, Parsons M, Levi CR. MIDAS (Modafinil in Debilitating Fatigue After Stroke): A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial. Stroke. 2017 May;48(5):1293-1298. doi: 10.1161/STROKEAHA.116.016293. Epub 2017 Apr 12.
- Background: PubMed 23399455Blikman LJ, Huisstede BM, Kooijmans H, Stam HJ, Bussmann JB, van Meeteren J. Effectiveness of energy conservation treatment in reducing fatigue in multiple sclerosis: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2013 Jul;94(7):1360-76. doi: 10.1016/j.apmr.2013.01.025. Epub 2013 Feb 8.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 15043967Chaudhuri A, Behan PO. Fatigue in neurological disorders. Lancet. 2004 Mar 20;363(9413):978-88. doi: 10.1016/S0140-6736(04)15794-2.
- Background: PubMed 10568903Corzillius M, Fortin P, Stucki G. Responsiveness and sensitivity to change of SLE disease activity measures. Lupus. 1999;8(8):655-9. doi: 10.1191/096120399680411416.
- Background: PubMed 24279835Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013 Dec;48(6 Pt 2):2134-56. doi: 10.1111/1475-6773.12117. Epub 2013 Oct 23.
- Background: PubMed 12785249Cup EH, Scholte op Reimer WJ, Thijssen MC, van Kuyk-Minis MA. Reliability and validity of the Canadian Occupational Performance Measure in stroke patients. Clin Rehabil. 2003 Jul;17(4):402-9. doi: 10.1191/0269215503cr635oa.
- Background: PubMed 15473118Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004 Sep;18(6):660-7. doi: 10.1191/0269215504cr746oa.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya Packer, PhD study director
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Managing Fatigue Program in people with Parkinson Disease, run by Dalhousie University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidimensional Fatigue Inventory (MFI) (time frame: Changes from baseline fatigue impact to six weeks later at post-test, and after a three-month follow up.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267107, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.