SclerodermaNCT04588714
Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
A study testing Resilience-based, Energy Management to Enhance Wellbeing (RENEW) in people with Scleroderma, run by University of Michigan at 1 site in United States.
Trial summary
Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to 31 May 2021
- 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
- Have a diagnosis of systemic sclerosis including:
- Diffuse or limited cutaneous
- Have access to a reliable, internet-connected device (e.g. computer, tablet)
- Be able to read, speak, and understand English
- Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions.
Who cannot join
- Complex, unstable health issues that would preclude full participation in the study
- Planning to start new treatment for fatigue, pain, mood during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.
- Conditions
- Scleroderma
- Being tested
- Resilience-based, Energy Management to Enhance Wellbeing (RENEW)
- Keywords
- Peer mentor, Web-based
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilience-based, Energy Management to Enhance Wellbeing (RENEW)Behavioural
The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.
| Study group | Role | What they receive |
|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing (RENEW) | Experimental | RENEW is a 12-week program in which participants are paired with a peer mentor who serves as their health coach throughout the intervention period. The website serves as the program "workbook" to help promote skill practice and attainment in areas like goal setting, pacing, relaxation, etc. Receives: Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as assessed by intervention participant retention
Number of participants who complete the study
Measured: 12 weeks
Feasibility as assessed by the participation in intervention related phone calls
Number of completed peer-mentor calls
Measured: 12 weeks
Secondary outcomes (3)
Feasibility as assessed by active participant involvement
Number of minutes spent accessing the RENEW website/app
Measured: 12 weeks
Feasibility as assessed by the peer mentor health coach time
Measured: 12 weeks
Feasibility as assessed by the time spent in preparation for intervention phone calls
Preparation time of peer mentors will be documented in minutes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start27 Oct 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study, one arm, pre-test, post-test trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, ScD, OTR/L, Principal investigator, University of MichiganDinesh Khanna, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588714
- Sponsor's protocol ID
- HUM00186877
- Status last verified
- Sep 2022
- First submitted
- 9 Oct 2020
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
- ClinicalTrials.gov ID
- NCT04588714
- Acronym / sponsor ID
- HUM00186877
- Conditions
- Scleroderma
- Keywords
- Peer mentor, Web-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 19 Oct 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.
Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study, one arm, pre-test, post-test trial
| Arm | Type | Receives |
|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing (RENEW) | Experimental | Behavioral: Resilience-based, Energy Management to Enhance Wellbeing (RENEW)RENEW is a 12-week program in which participants are paired with a peer mentor who serves as their health coach throughout the intervention period. The website serves as the program "workbook" to help promote skill practice and attainment in areas like goal setting, pacing, relaxation, etc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of systemic sclerosis including:
- Have access to a reliable, internet-connected device (e.g. computer, tablet)
- Be able to read, speak, and understand English
- Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions.
Key exclusion criteria (2 listed)
- Complex, unstable health issues that would preclude full participation in the study
- Planning to start new treatment for fatigue, pain, mood during the study period
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 |
|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing (RENEW)The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor. | Behavioural | Resilience-based, Energy Management to Enhance Wellbeing (RENEW) |
Primary outcome
Feasibility as assessed by intervention participant retention
Time frame: 12 weeks
Number of participants who complete the study
Feasibility as assessed by the participation in intervention related phone calls
Time frame: 12 weeks
Number of completed peer-mentor calls
3 secondary outcomes
Feasibility as assessed by active participant involvement
Time frame: 12 weeks
Feasibility as assessed by the peer mentor health coach time
Time frame: 12 weeks
Feasibility as assessed by the time spent in preparation for intervention phone calls
Time frame: 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 23 Sep 2022.
- 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.
Susan Murphy, ScD, OTR/L principal investigator
University of Michigan
Dinesh Khanna, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilience-based, Energy Management to Enhance Wellbeing (RENEW) in people with Scleroderma, run by University of Michigan at 1 site in United States.
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 2 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 23 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 United States. 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 as assessed by intervention participant retention (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2022.