Inflammatory ArthritisFAME-WNCT05138445
Effectiveness of Fatigue and Activity Management in Work (FAME-W) for Individuals With Inflammatory Arthritis
A study testing FAME-W self-management intervention and FAME-W Handbook in people with Inflammatory Arthritis, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- FAME-W self-management intervention and FAME-W Handbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 28 Jan 2021to 30 Sep 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Inflammatory Arthritis,
- In full-time or part-time employment
- Must be able to provide informed consent,
- Must be able to participate in a four-week group-based self-management intervention
- Must have access to an electronic device and stable internet access
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Trinity College Dublin
Dublin, Leinster, D08 EF20
Deirdre Connolly, PhD, +35318963216 ext. 3216, connoldm@tcd.ie
Shalaleh Karkon, MSc, +35318963216, karkons@tcd.ie
About this study
Official title: Testing the Effectiveness of Fatigue and Activity Management in Work (FAME-W) Self-management Intervention for Individuals With Inflammatory Arthritis
Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Loss of ability to continue paid employment results in physical, emotional and financial hardship for individuals with IA and has societal and economic implications. Previous research has identified pain and fatigue as dominant symptoms that interfere with work capacity and therefore interventions are required to reduce the impact of these symptoms on work activities. The purpose of this study therefore is to test the effectiveness of a 4-week Fatigue and Activity Management Education for Work intervention. The study will use a mixed methods design. A randomized control trial will test the effectiveness of the intervention and a qualitative process evaluation with explore acceptability and participants' experiences of the intervention. Individuals with IA, of working age, will be recruited in Rheumatology outpatient departments of three hospitals. Study participants will be randomly assigned to a four-week online self-management intervention or a self-guided symptom management workbook. Study measures consist of self-report questionnaires related to work and symptom management. All participants will also be invited to an interview to discuss their experience of participating in the study.
Read the detailed description
Rheumatic diseases (RD) include over 100 different types of arthritis, the most frequently occurring being Rheumatoid Arthritis, Osteoarthritis, Scleroderma, Systemic Lupus erythmatosus and ankylsoing Spondylitis. However, Inflammatory Arthritis (IA) are one of the most common causes of work disability and despite improvements in medical management of IA, up to 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity.
This study builds on existing research investigating the impact of IA on work performance of individuals. These earlier studies examined how symptoms of fatigue, pain and stress impact on work capacity of individuals with IA. Based on the findings of these studies a self-management program, FAtigue Management Education for Work (FAME-W) was designed to reduce the impact of fatigue, pain and stress on work performance of individuals with IA. Pilot testing of FAME-W, with a non-experimental design, showed improvements in fatigue, work performance, pain and mood following participation in FAME-W. The proposed study will build on this research by testing the effectiveness of FAME-W as a work-focused self-management intervention to increase work performance of individuals with IA.
Project Design and Methodology
Study Aim
The purpose of this study is to test the effectiveness and acceptability of FAME-W to manage the physical, mental and social demands of work of individuals with IA.
Study Objectives
- To test the effectiveness of FAME-W in reducing the impact of fatigue, pain and stress on work performance of individuals with Inflammatory Arthritis.
- To test the effectiveness of FAME-W in improving work ability of individuals with Inflammatory Arthritis
- To explore the acceptability of FAME-W as a work-based self-management intervention for individuals with Inflammatory Arthritis
Study Design
The study methodology will follow the United Kingdom Medical Research Council (MRC) framework for evaluating complex interventions. A complex intervention consists of a number of interacting components such as those included in the FAME-W intervention. The MRC framework recommends collecting quantitative and qualitative data when evaluating complex interventions. This study will therefore use a sequential exploratory mixed methods design.
The quantitative phase will be a pragmatic randomized control trial (RCT) to test the effectiveness of FAME-W as a work focused self-management intervention to improve individuals' ability to manage their work demands. The CONSORT guidelines for the design and reporting of RCTs will be used at all stages from recruitment, randomization, data collection, analysis and reporting. For the purposes of the proposed study, participants will be randomly allocated to either the group based FAME-W intervention or to a handbook only group. Participants randomized to the group-based FAME-W group will attend an online four-week FAME-W program. The participants in handbook only group will be given a self-guided FAME-W handbook.
The qualitative phase will use a Qualitative Descriptive (QD) design to explore participants' experiences and acceptability of FAME-W. QD is frequently used in health research to evaluate the acceptability and sustainability of health-related interventions. It is considered an appropriate methodology for needs assessments and for informing the planning and delivery of clinical interventions.
Sample Size
Based on the previous studies the individual scores for Work Role Functioning (WRF) questionnaire this study is powered for an effect size of 0.7. To detect an 0.7, 100 participants are required (50 for the group intervention and 50 for handbook only group) to show significance at 5% level, 80% power. Participants will be recruited in groups of 12-14 and then allocated to the intervention or control group using random allocation software.
Data collection methods
Quantitative Data:
Patient Reported Outcome Measures (PROMS, outlined below) will be used to collect quantitative data
Qualitative phase: Qualitative data will be collected from individual interviews and focus groups.
Data collection will be carried out immediately before FAME-W commences, immediately following completion of FAME-W, and 3 months following completion of the program.
Data analysis Quantitative data: Baseline characteristics will be analyzed using descriptive statistics. Multilevel linear regression will be used to examine differences between groups for the primary and secondary outcome measures. Statistical significance at p<0.05 will be assumed throughout.
Qualitative data: Semi-structured interviews will be audio-taped and transcribed. Data analysis will be guided by Braun and Clarke's seven stage thematic analysis of qualitative data.
- Conditions
- Inflammatory Arthritis
- Being tested
- FAME-W self-management intervention, FAME-W Handbook
- Keywords
- Work disability, Self-management, Fatigue management, Occupational Therapy
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAME-W self-management interventionBehavioural
FAME-W is an occupational therapy led, four-week group based self-management intervention. It focuses on providing people with IA skills and confidence to manage demands of their employment and daily life through education on IA, self-management techniques, managing symptoms of fatigue, pain and stress and managing physical and mental health.
FAME-W HandbookBehavioural
Individuals in this arm receive a self-guided FAME-W handbook containing the same information as that covered in the four week FAME-W program
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: FAME-W intervention | Experimental | Four-week self-management education programme Receives: Behavioral: FAME-W self-management intervention |
| Arm 2: FAME-W handbook | Active comparator | Self-guided FAME-W handbook Receives: Behavioral: FAME-W Handbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Role Functioning Questionnaire
Work Role Functioning questionnaire is a 27-self-report questionnaire that measures an individual's ability to meet demands of five categories of work: scheduling, output, psychical, mental and social demands. All 27 items are scored on a five point scale, with a score of four given for the response 'difficult none of the time' and a score of zero representing 'difficult all of the time'. Each of the five sub-scales are scored separately. A score is established by adding the response of each item, calculating the average and multiplying this by 25 to achieve an overall percentage. The overall percent can range from 0% (difficult all of the time), to 100% (never difficult) meeting the demands of the job.
Measured: Three months
Secondary outcomes (7)
Euro QoL 5 Dimensions -5 levels (5D-5L)
Euro QoL 5 Dimensions -5 levels scale evaluates the health-related quality of life and compromises two components: a health descriptive component and a visual analog scale (VAS) . It has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each category is scored from 1 (no problem) to 5 (extreme problems). Scores range from 1-25. Higher scores represent higher levels of difficulty. A visual analogue scale measures self-perception of health-related quality of life on a scale of 0-100. Higher scores represent better levels of health-related quality of life.
Measured: Three months
Multidimensional Fatigue Inventory
Multidimensional Fatigue Inventory evaluates five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. It is a 20-item self-report questionnaire scored from 4 to 20. Higher scores indicate higher levels of fatigue
Measured: Three months
Arthritis Work Spillover
Arthritis Work Spillover is designed to assess the extent to which the demands of arthritis interfere with work performance and the extent to which work interferes with managing arthritis. Items are scored on a 5-point Likert scale where 1= strongly disagree and 5 = strongly agree. Scores range from 6 - 30. Higher scores indicate higher level of interference between work and arthritis
Measured: Three months
Hospital Anxiety and Depression scale (HADS)
This scale is a self-report measure with two sub scales for measuring anxiety and depression. Each scale contains seven items and ranges from a score of 0 to 21. Higher scores indicate higher levels of anxiety and depression.
Measured: Three months
The Stanford Arthritis Self-Efficacy Scale Short Form
The Stanford Arthritis Self-Efficacy Scale Short Form is a self-administered, 20-item disease-specific questionnaire suitable for all types of arthritis. It consists of three sub scales: physical function, other symptoms, and pain.Each item is scored between one (very uncertain) and 10 (very certain) with higher scores indicating higher levels of self-efficacy.
Measured: Three months
The Arthritis Impact Measurement Scale
The Arthritis Impact Measurement Scale was developed to measure the physical, mental, and emotional well-being of individuals with arthritis. It consists of five domains: physical functioning, symptoms, mood/affect, social interaction, and work-role components. Scores range from 0-10. Higher scores indicate poorer overall health.
Measured: Three months
The Short Form McGill Pain Questionnaire
The Short Form McGill Pain Questionnaire was developed to measure pain in adults with chronic pain, including individuals with rheumatic conditions. Scores range from zero to 10 with higher scores indicating higher levels of pain intensity
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start28 Jan 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- St. James Hospital, Tallaght University Hospital, University Hospital Waterford
- Responsible party
- Principal investigator, Deirdre Connolly, University of Dublin, Trinity College
- Investigators
- Deirdre Connolly, PhD, Principal investigator, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138445
- Sponsor's protocol ID
- UDublinOT
- Acronym
- FAME-W
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data may be shared for results presented in publications of quantitative data on request to the study contact person.
Publications
Karkon S, Bennett KE, O'Shea F, Doran M, Connolly D. Testing the effectiveness of a Fatigue and Activity Management Education for Work (FAME-W) intervention for individuals with inflammatory arthritis: Study protocol for a randomized control trial. Musculoskeletal Care. 2023 Dec;21(4):1629-1638. doi: 10.1002/msc.1839. Epub 2023 Nov 7.
PubMed 37937322
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Fatigue and Activity Management in Work (FAME-W) Self-management Intervention for Individuals With Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT05138445
- Acronym / sponsor ID
- FAME-W / UDublinOT
- Conditions
- Inflammatory Arthritis
- Keywords
- Work disability, Self-management, Fatigue management, Occupational Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- St. James Hospital, Tallaght University Hospital, University Hospital Waterford
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 1 Dec 2021 (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.
Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Loss of ability to continue paid employment results in physical, emotional and financial hardship for individuals with IA and has societal and economic implications. Previous research has identified pain and fatigue as dominant symptoms that interfere with work capacity and therefore interventions are required to reduce the impact of these symptoms on work activities. The purpose of this study therefore is to test the effectiveness of a 4-week Fatigue and Activity Management Education for Work intervention. The study will use a mixed methods design. A randomized control trial will test the effectiveness of the intervention and a qualitative process evaluation with explore acceptability and participants' experiences of the intervention. Individuals with IA, of working age, will be recruited in Rheumatology outpatient departments of three hospitals. Study participants will be randomly assigned to a four-week online self-management intervention or a self-guided symptom management workbook. Study measures consist of self-report questionnaires related to work and symptom management. All participants will also be invited to an interview to discuss their experience of participating in the study.
Detailed description
Rheumatic diseases (RD) include over 100 different types of arthritis, the most frequently occurring being Rheumatoid Arthritis, Osteoarthritis, Scleroderma, Systemic Lupus erythmatosus and ankylsoing Spondylitis. However, Inflammatory Arthritis (IA) are one of the most common causes of work disability and despite improvements in medical management of IA, up to 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity.
This study builds on existing research investigating the impact of IA on work performance of individuals. These earlier studies examined how symptoms of fatigue, pain and stress impact on work capacity of individuals with IA. Based on the findings of these studies a self-management program, FAtigue Management Education for Work (FAME-W) was designed to reduce the impact of fatigue, pain and stress on work performance of individuals with IA. Pilot testing of FAME-W, with a non-experimental design, showed improvements in fatigue, work performance, pain and mood following participation in FAME-W. The proposed study will build on this research by testing the effectiveness of FAME-W as a work-focused self-management intervention to increase work performance of individuals with IA.
Project Design and Methodology
Study Aim
The purpose of this study is to test the effectiveness and acceptability of FAME-W to manage the physical, mental and social demands of work of individuals with IA.
Study Objectives
- To test the effectiveness of FAME-W in reducing the impact of fatigue, pain and stress on work performance of individuals with Inflammatory Arthritis.
- To test the effectiveness of FAME-W in improving work ability of individuals with Inflammatory Arthritis
- To explore the acceptability of FAME-W as a work-based self-management intervention for individuals with Inflammatory Arthritis
Study Design
The study methodology will follow the United Kingdom Medical Research Council (MRC) framework for evaluating complex interventions. A complex intervention consists of a number of interacting components such as those included in the FAME-W intervention. The MRC framework recommends collecting quantitative and qualitative data when evaluating complex interventions. This study will therefore use a sequential exploratory mixed methods design.
The quantitative phase will be a pragmatic randomized control trial (RCT) to test the effectiveness of FAME-W as a work focused self-management intervention to improve individuals' ability to manage their work demands. The CONSORT guidelines for the design and reporting of RCTs will be used at all stages from recruitment, randomization, data collection, analysis and reporting. For the purposes of the proposed study, participants will be randomly allocated to either the group based FAME-W intervention or to a handbook only group. Participants randomized to the group-based FAME-W group will attend an online four-week FAME-W program. The participants in handbook only group will be given a self-guided FAME-W handbook.
The qualitative phase will use a Qualitative Descriptive (QD) design to explore participants' experiences and acceptability of FAME-W. QD is frequently used in health research to evaluate the acceptability and sustainability of health-related interventions. It is considered an appropriate methodology for needs assessments and for informing the planning and delivery of clinical interventions.
Sample Size
Based on the previous studies the individual scores for Work Role Functioning (WRF) questionnaire this study is powered for an effect size of 0.7. To detect an 0.7, 100 participants are required (50 for the group intervention and 50 for handbook only group) to show significance at 5% level, 80% power. Participants will be recruited in groups of 12-14 and then allocated to the intervention or control group using random allocation software.
Data collection methods
Quantitative Data:
Patient Reported Outcome Measures (PROMS, outlined below) will be used to collect quantitative data
Qualitative phase: Qualitative data will be collected from individual interviews and focus groups.
Data collection will be carried out immediately before FAME-W commences, immediately following completion of FAME-W, and 3 months following completion of the program.
Data analysis Quantitative data: Baseline characteristics will be analyzed using descriptive statistics. Multilevel linear regression will be used to examine differences between groups for the primary and secondary outcome measures. Statistical significance at p<0.05 will be assumed throughout.
Qualitative data: Semi-structured interviews will be audio-taped and transcribed. Data analysis will be guided by Braun and Clarke's seven stage thematic analysis of qualitative data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: FAME-W intervention | Experimental | Behavioral: FAME-W self-management interventionFour-week self-management education programme |
| Arm 2: FAME-W handbook | Active comparator | Behavioral: FAME-W HandbookSelf-guided FAME-W handbook |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Inflammatory Arthritis,
- In full-time or part-time employment
- Must be able to provide informed consent,
- Must be able to participate in a four-week group-based self-management intervention
- Must have access to an electronic device and stable internet access
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FAME-W self-management interventionFAME-W is an occupational therapy led, four-week group based self-management intervention. It focuses on providing people with IA skills and confidence to manage demands of their employment and daily life through education on IA, self-management techniques, managing symptoms of fatigue, pain and stress and managing physical and mental health. | Behavioural | Arm 1: FAME-W intervention |
| FAME-W HandbookIndividuals in this arm receive a self-guided FAME-W handbook containing the same information as that covered in the four week FAME-W program | Behavioural | Arm 2: FAME-W handbook |
Primary outcome
Work Role Functioning Questionnaire
Time frame: Three months
Work Role Functioning questionnaire is a 27-self-report questionnaire that measures an individual's ability to meet demands of five categories of work: scheduling, output, psychical, mental and social demands. All 27 items are scored on a five point scale, with a score of four given for the response 'difficult none of the time' and a score of zero representing 'difficult all of the time'. Each of the five sub-scales are scored separately. A score is established by adding the response of each item, calculating the average and multiplying this by 25 to achieve an overall percentage. The overall percent can range from 0% (difficult all of the time), to 100% (never difficult) meeting the demands of the job.
7 secondary outcomes
Euro QoL 5 Dimensions -5 levels (5D-5L)
Time frame: Three months
Multidimensional Fatigue Inventory
Time frame: Three months
Arthritis Work Spillover
Time frame: Three months
Hospital Anxiety and Depression scale (HADS)
Time frame: Three months
The Stanford Arthritis Self-Efficacy Scale Short Form
Time frame: Three months
The Arthritis Impact Measurement Scale
Time frame: Three months
The Short Form McGill Pain Questionnaire
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 37937322Karkon S, Bennett KE, O'Shea F, Doran M, Connolly D. Testing the effectiveness of a Fatigue and Activity Management Education for Work (FAME-W) intervention for individuals with inflammatory arthritis: Study protocol for a randomized control trial. Musculoskeletal Care. 2023 Dec;21(4):1629-1638. doi: 10.1002/msc.1839. Epub 2023 Nov 7.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data may be shared for results presented in publications of quantitative data on request to the study contact person.
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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.
Deirdre Connolly, PhD principal investigator
University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAME-W self-management intervention and FAME-W Handbook in people with Inflammatory Arthritis, run by University of Dublin, Trinity College at 1 site in Ireland.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Deirdre Connolly, PhD (+35318963216, connoldm@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Work Role Functioning Questionnaire (time frame: Three months). 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 NCT05138445, which also lists 1 linked publication.
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 1 Dec 2021.