Osteoarthritis, KneeAktiWebNCT04084834
Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis
A study testing Exercise in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorway
- Study dates
- 9 Oct 2019to 1 Jun 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with hip and/or knee osteoarthritis being referred to Diakonhjemmet Hospital
Who cannot join
- candidate for surgery
- unable to understand or write Norwegian
- unable to walk unaided and continuously for 15 minutes
- absolute or relative contradictions to maximal exercise testing
- have relatives with sudden death before 40 years of age
- have first-degree relatives with hypertrophic cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. The project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (OA). However, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. Development of innovative and effective treatment trajectories and follow-up strategies is urgently required. Peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. Thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. After discharge from examination in hospital, patients with hip/knee OA will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.
Read the detailed description
The study will be conducted as a pre-post single-arm feasibility study comprising 50 participants.
The main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee OA.
Specific research objectives are:
- to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity
- to assess the responsiveness of relevant primary and secondary outcome measures
In the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. Patients between 40 and 80 years of age that are not candidates for surgery will be recruited from Diakonhjemmet Hospital, Oslo, Norway.
To assess and evaluate feasibility, we will report on descriptive statistics. Responsiveness will be assessed using Receiver Operating Curve (ROC) analyses.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Exercise
- Keywords
- Exercise
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital, receiving information about the osteoarthritis disease, symptoms and the importance of exercise and physical activity. Participants will then be given a weekly web-based exercise program (12 weeks) consisting of three aerobic exercise sessions per week. The exercise program consists of five levels, and the participants will each week be guided to the most appropriate level based on their measured physical fitness level and the weekly exercise diary. The participants will at initial assessment at Diakonhjemmet Hospital be instructed to use Borgs scale to adjust exercise level. Based on the weekly exercise diary the participants will also get motivational messages by email.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants allocated to the intervention group will be familiarized with exercise intensity levels (heart rate and Borg RPE) during the assessment at Diakonhjemmet Hospital. Further, the patients will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital. Thereafter, the participants will get access to a web-based exercise program and guided to choose the appropriate exercise-level. Weekly, based on the individual progression, all participants will receive an exercise program by email consisting of individually tailored exercise sessions and motivational messages. At the end of each week, the participants complete an electronic exercise diary for monitoring adherence. All participants will be offered the possibility to seek peer-support; however, if preferred they may also follow the exercise program by themselves. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: time resources used by peer-supporters
Time (hours/minutes) per participant-peer-support contact (frequency of contacts divided by total time used by peer-supporters).
Measured: baseline to 12 weeks
Feasibility: time resources used on the exercise program delivery
Time (hours/minutes) per week per participant used on web-based exercise program delivery.
Measured: baseline to 12 weeks
Feasibility: time resources used on motivational messages delivery
Time (hours/minutes) per week per participant used on motivational message delivery.
Measured: baseline to 12 weeks
Feasibility: proportion of received exercise diaries
Proportion of received exercise diaries (0-12 per participant).
Measured: baseline to 12 weeks
Feasibility: proportion wearing the activity monitor
Proportion of participants providing activity monitor data (at least 4 days, including one weekend day, with minimum 10 hours recording per day) at baseline.
Measured: baseline
Feasibility: proportion completing treadmill test
Proportion of participants completing the indirect maximal cardiorespiratory exercise test according to test-protocol at baseline.
Measured: baseline
Eligible: proportion eligible
Proportion of potentially eligible participants approached that are invited.
Measured: baseline
Recruitment: proportion enrolled
Proportion of eligible patients enrolled.
Measured: baseline
Retention: proportion of enrolled participants
Proportion of enrolled participants providing data at 12 week post-test.
Measured: baseline and 12 weeks
Adverse events: number of adverse events
Total number of adverse events (by cause if possible) evaluated by answers at post-test: The four questions addressing possible adverse events: 1) Have you carried out any type of treatment during the last 3 months? (With treatment we mean medication, physical exercise, self-management course or any alternative treatments) (yes/no), 2) If yes, have you experienced any adverse event as a result of the treatment? (yes/no). 3) If yes, which adverse events as a result of treatment? 4) In your opinion, which treatment(s) do you think the adverse event was/were caused by? (medication, physical exercise, self-management course, alternative treatments, other) (Elaborate).
Measured: 12 weeks
Secondary outcomes (13)
Changes in objectively measured physical activity
Assessed by accelerometer (ActiGraph GT3X+): Change in physical activity level measured as counts per minute (CPM), which is the total number of registered counts for all valid days divided by wear time. Thresholds for CPM will be used in calculation of time (minutes per week/day) spent on sitting (<100 CPM), and on light (100-2019 CPM), moderate-(>2019-5998 CPM) and vigorous (>5998) intensity physical activity.
Measured: baseline and 12 weeks
Change in physical fitness (VO2 peak)
Change in VO2 peak measured by indirect maximal cardiorespiratory exercise test (modified Balke-protocol). The indirect estimation of VO2 peak by prediction equations is based on incline, grade and speed at end stage, weight and age.
Measured: baseline and 12 weeks
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Change in the last week disability on five subscales; pain (10 items, scale 0-40), symptoms (5 items, scale 0-20), function in daily living (17 items, scale 0-68), function in sport and recreation (4 items, scale 0-16) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability).
Measured: baseline and 12 weeks
Change in Knee disability and Osteoarthritis Outcome Score (KOOS)
Change in the last week disability on five subscales; pain (9 items, scale 0-36), symptoms (7 items, scale 0-28), function in daily living (17 items, scale 0-68), function in sport and recreation (5 items, scale 0-20) and quality of life (4 items, scale 0-16). Items are scored by a five-point Likert scale ranging from 0 (least severe) to 4 (most severe). Total sum-score and subscale sum-scores will be converted to normalized scores ranging from 0 (extreme disability) to 100 (no disability).
Measured: baseline and 12 weeks
Change in Patient-specific functional scale (PSFS)
Patients will address one to three activities they have problems performing due to osteoarthritis. The degree of difficulty with performing these activities is rated from 0 (cannot perform the activity) to 10 (no problems).
Measured: baseline and 12 weeks
Change in self-reported physical activity (International Physical Activity Questionnaire-Short Form)
Measured by The International Physical Activity Questionnaire-Short Form: Change in time (minutes per week/day) and Metabolic Equivalent of Task (MET-minutes per week/day) spent on sitting, walking, and moderate- and vigorous intensity physical activity the last week (0-7 days). METs are calculated by using the corresponding MET-values for walking (3.3 MET), and moderate-(4.0 MET) and vigorous (8.0 MET) intensity physical activity.
Measured: baseline and 12 weeks
Change in self-reported physical activity (HUNT)
Measured by the three questions from the Nord-Trøndelag Health study (HUNT): change in average frequency (never/<1 per week/1 per week/2-3 per week/almost every day), intensity (easy without losing my breath or breaking into a sweat/so hard that I lose my breath and break into a sweat/I push myself to near-exhaustion) and duration (less than 15 minutes/15-29 minutes/30 minutes to 1 hour/more than 1 hour) of physical activity.
Measured: baseline and 12 weeks
Change in self-reported pain intensity the last week
Measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain).
Measured: baseline and 12 weeks
Change in self-reported fatigue the last week
Measured by numeric rating scale ranging from 0 (no fatigue) to 10 (worst fatigue).
Measured: baseline and 12 weeks
Change in self-reported disease activity the last week
Measured by numeric rating scale ranging from 0 (good, no symptoms) to 10 (very bad, much symptoms).
Measured: baseline and 12 weeks
Change in Health-related quality of life (EQ-5D-5L)
EQ-5D-5L will be used for measuring health-related quality of life (www.euroqol.org): comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of answers (no problems, slight problems, moderate problems, severe problems, and extreme problems). The average score on each dimension will be reported, and the total score can be calculated into an index value ranging from -0.59 to 1, where -0.59 represents worst possible state and 1 represents perfect health.
Measured: baseline and 12 weeks
Change in Arthritis Self-Efficacy Scale (ASES)
Measured by Arthritis Self-Efficacy Scale (ASES): comprises 11 items addressing pain and symptoms (scored on a 5-point scale ranging from not confident at all to very confident). The scores are summed up to a 0-100 score where higher score indicate better self-efficacy.
Measured: baseline and 12 weeks
Change in exercise self-efficacy
Measured by Exercise Beliefs and Exercise Habits questionnaire: comprises 20 items addressing exercise self-efficacy (4 items), barriers to exercise (3 items), benefits of exercise (5 items), and impact of exercise on arthritis (8 items), scored on a 5-point Likert scale ranging from strongly disagree to strongly agree. The scores on each subscale is summed up where higher scores indicate better self-efficacy.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start9 Oct 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A pre-post single arm feasibility study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Norwegian Rheumatism Association, University of Melbourne, Extrastiftelsen
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, National Resource Center on Research in Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084834
- Sponsor's protocol ID
- 2018/2198-feasibility
- Acronym
- AktiWeb
- Status last verified
- Sep 2022
- First submitted
- 21 Aug 2019
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can possibly be made available on request
Publications
Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis. J Rehabil Med. 2023 Aug 14;55:jrm7139. doi: 10.2340/jrm.v55.7139.
PubMed 37578100Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. The AktiWeb study: feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis. Pilot Feasibility Stud. 2022 Jul 20;8(1):150. doi: 10.1186/s40814-022-01110-3.
PubMed 35859065
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Web-based, Peer-supported Exercise Program for Patients With Hip and/or Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04084834
- Acronym / sponsor ID
- AktiWeb / 2018/2198-feasibility
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- The Norwegian Rheumatism Association, University of Melbourne, Extrastiftelsen
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 10 Sep 2019 (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.
In this project, a web-based exercise program is developed in co-creation between specialized health care, the Norwegian Association for Rheumatic diseases (NRF) and a group of experienced patient representatives. The project emerges from the evidence that exercise is recommended as first-line treatment for patients with chronic diseases like hip- and knee-osteoarthritis (OA). However, the number of patients in need of targeted exercise will increase considerably the next decades, and their treatment needs cannot be fully handled within the health care system. Development of innovative and effective treatment trajectories and follow-up strategies is urgently required. Peer-support is recognized as an effective way to increase patients' long-term adherence to exercise. Thus, patient-organizations may be an unutilized resource in support and follow-up of patients who need long-term exercise as part of their treatment plan. After discharge from examination in hospital, patients with hip/knee OA will be recruited to follow-up in a novel web-based, peer-supported exercise program, and the feasibility of the intervention will be evaluated.
Detailed description
The study will be conducted as a pre-post single-arm feasibility study comprising 50 participants.
The main objective of the study will be to evaluate the feasibility of the web-based, peer-supported exercise intervention in patients with hip and/or knee OA.
Specific research objectives are:
- to assess feasibility of intervention delivery, data collection, eligibility and inclusion/exclusion criteria and intervention fidelity
- to assess the responsiveness of relevant primary and secondary outcome measures
In the feasibility study, all participants will be allocated to an intervention group, receiving a 12-week web-based, peer-supported aerobic exercise program including weekly motivational messages. Patients between 40 and 80 years of age that are not candidates for surgery will be recruited from Diakonhjemmet Hospital, Oslo, Norway.
To assess and evaluate feasibility, we will report on descriptive statistics. Responsiveness will be assessed using Receiver Operating Curve (ROC) analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A pre-post single arm feasibility study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: ExerciseParticipants allocated to the intervention group will be familiarized with exercise intensity levels (heart rate and Borg RPE) during the assessment at Diakonhjemmet Hospital. Further, the patients will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital. Thereafter, the participants will get access to a web-based exercise program and guided to choose the appropriate exercise-level. Weekly, based on the individual progression, all participants will receive an exercise program by email consisting of individually tailored exercise sessions and motivational messages. At the end of each week, the participants complete an electronic exercise diary for monitoring adherence. All participants will be offered the possibility to seek peer-support; however, if preferred they may also follow the exercise program by themselves. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with hip and/or knee osteoarthritis being referred to Diakonhjemmet Hospital
Key exclusion criteria (6 listed)
- candidate for surgery
- unable to understand or write Norwegian
- unable to walk unaided and continuously for 15 minutes
- absolute or relative contradictions to maximal exercise testing
- have relatives with sudden death before 40 years of age
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 |
|---|---|---|
| ExerciseParticipants will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital, receiving information about the osteoarthritis disease, symptoms and the importance of exercise and physical activity. Participants will then be given a weekly web-based exercise program (12 weeks) consisting of three aerobic exercise sessions per week. The exercise program consists of five levels, and the participants will each week be guided to the most appropriate level based on their measured physical fitness level and the weekly exercise diary. The participants will at initial assessment at Diakonhjemmet Hospital be instructed to use Borgs scale to adjust exercise level. Based on the weekly exercise diary the participants will also get motivational messages by email. | Other | Intervention group |
Primary outcome
Feasibility: time resources used by peer-supporters
Time frame: baseline to 12 weeks
Time (hours/minutes) per participant-peer-support contact (frequency of contacts divided by total time used by peer-supporters).
Feasibility: time resources used on the exercise program delivery
Time frame: baseline to 12 weeks
Time (hours/minutes) per week per participant used on web-based exercise program delivery.
Feasibility: time resources used on motivational messages delivery
Time frame: baseline to 12 weeks
Time (hours/minutes) per week per participant used on motivational message delivery.
Feasibility: proportion of received exercise diaries
Time frame: baseline to 12 weeks
Proportion of received exercise diaries (0-12 per participant).
Feasibility: proportion wearing the activity monitor
Time frame: baseline
Proportion of participants providing activity monitor data (at least 4 days, including one weekend day, with minimum 10 hours recording per day) at baseline.
Feasibility: proportion completing treadmill test
Time frame: baseline
Proportion of participants completing the indirect maximal cardiorespiratory exercise test according to test-protocol at baseline.
Eligible: proportion eligible
Time frame: baseline
Proportion of potentially eligible participants approached that are invited.
Recruitment: proportion enrolled
Time frame: baseline
Proportion of eligible patients enrolled.
Retention: proportion of enrolled participants
Time frame: baseline and 12 weeks
Proportion of enrolled participants providing data at 12 week post-test.
Adverse events: number of adverse events
Time frame: 12 weeks
Total number of adverse events (by cause if possible) evaluated by answers at post-test: The four questions addressing possible adverse events: 1) Have you carried out any type of treatment during the last 3 months? (With treatment we mean medication, physical exercise, self-management course or any alternative treatments) (yes/no), 2) If yes, have you experienced any adverse event as a result of the treatment? (yes/no). 3) If yes, which adverse events as a result of treatment? 4) In your opinion, which treatment(s) do you think the adverse event was/were caused by? (medication, physical exercise, self-management course, alternative treatments, other) (Elaborate).
13 secondary outcomes
Changes in objectively measured physical activity
Time frame: baseline and 12 weeks
Change in physical fitness (VO2 peak)
Time frame: baseline and 12 weeks
Change in Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: baseline and 12 weeks
Change in Knee disability and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline and 12 weeks
Change in Patient-specific functional scale (PSFS)
Time frame: baseline and 12 weeks
Change in self-reported physical activity (International Physical Activity Questionnaire-Short Form)
Time frame: baseline and 12 weeks
Change in self-reported physical activity (HUNT)
Time frame: baseline and 12 weeks
Change in self-reported pain intensity the last week
Time frame: baseline and 12 weeks
Change in self-reported fatigue the last week
Time frame: baseline and 12 weeks
Change in self-reported disease activity the last week
Time frame: baseline and 12 weeks
Change in Health-related quality of life (EQ-5D-5L)
Time frame: baseline and 12 weeks
Change in Arthritis Self-Efficacy Scale (ASES)
Time frame: baseline and 12 weeks
Change in exercise self-efficacy
Time frame: baseline and 12 weeks
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 22 Sep 2022.
- Derived from this study: PubMed 37578100Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. Adherence to a Web-based Exercise Programme: A Feasibility Study Among Patients with Hip or Knee Osteoarthritis. J Rehabil Med. 2023 Aug 14;55:jrm7139. doi: 10.2340/jrm.v55.7139.
- Derived from this study: PubMed 35859065Joseph KL, Dagfinrud H, Hagen KB, Norden KR, Fongen C, Wold OM, Hinman RS, Nelligan RK, Bennell KL, Tveter AT. The AktiWeb study: feasibility of a web-based exercise program delivered by a patient organisation to patients with hip and/or knee osteoarthritis. Pilot Feasibility Stud. 2022 Jul 20;8(1):150. doi: 10.1186/s40814-022-01110-3.
- Individual participant dataSharing planned: No. Data can possibly be made available on request
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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.
Anne Therese Tveter, PhD principal investigator
National Resource Center on Research in Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Diakonhjemmet Hospital at 1 site in Norway.
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 1 inclusion and 6 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 22 Sep 2022. 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 Norway. 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?
Feasibility: time resources used by peer-supporters (time frame: baseline to 12 weeks). The study lists 10 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 NCT04084834, which also lists 2 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 22 Sep 2022.