SclerodermaRENEWNCT04908943
RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
A study testing RENEW in people with Scleroderma, run by University of Michigan at 1 site in United States.
Trial summary
The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- RENEW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2021to 29 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of Systemic Sclerosis (SSc), any subtype
- Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
- Have access to a computer and an internet connection
- Are able to speak and read English.
Who cannot join
- Currently undergoing structured rehabilitation or psychological treatment.
- Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.
- Conditions
- Scleroderma
- Being tested
- RENEW
- Keywords
- Systemic Sclerosis
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEWBehavioural
RENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being.
| Study group | Role | What they receive |
|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) | Experimental | RENEW was created by researchers, doctors, and patients with scleroderma. It is a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Receives: Behavioral: RENEW |
| Waitlist | No intervention | Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue
Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue.
Measured: Up to 12 weeks
Secondary outcomes (3)
Change in Pain Interference
Pain interference is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a scale Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from "not at all" to "very much". The minimum score is 4 and the maximum score is 20. Lower scores suggest less pain interference.
Measured: Up to 12 weeks
Change in Resilience
Resilience is measured by Connor-Davidson Resilience Scale 10 (CD-RISC-10). It is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience).
Measured: Up to 12 weeks
Change in Depressive symptoms
Depressive symptoms are measured by PROMIS depression 4a assesses self-reported negative mood (e.g., sadness), views of self (e.g., worthlessness), social cognition (e.g., loneliness), and decreased positive affect and engagement. Items are all answered on a 5-point scale from 1=Never to 5=Always. Scores can range from 0 meaning no anxiety/depression to 40 meaning high
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start28 Aug 2021
- Primary completion29 May 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan Murphy, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908943
- Sponsor's protocol ID
- HUM00195121
- Acronym
- RENEW
- Status last verified
- Nov 2023
- First submitted
- 26 May 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified data that underlie the results reported in the article will be shared with researchers who present a methodologically sound proposal.
Publications
Chen YT, Hassett AL, Khanna D, Murphy SL. Resilience partially mediates the association between perceived social isolation and life satisfaction in people with systemic sclerosis. J Scleroderma Relat Disord. 2024 Jun;9(2):154-161. doi: 10.1177/23971983241232853. Epub 2024 Mar 5.
PubMed 38910596Chen YT, Hassett AL, Huang S, Khanna D, Murphy SL. Peer-Led Symptom Management Intervention to Enhance Resilience in People With Systemic Sclerosis: Mediation Analysis From a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1278-1286. doi: 10.1002/acr.25352. Epub 2024 May 31.
PubMed 38622109Chen YT, Harper AE, Phanhdone T, Alore M, Hicks S, Pape A, Jay GM, Bolde S, Feldpausch J, Guetterman TC, Khanna D, Murphy SL. Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study. Rheumatol Adv Pract. 2024 Mar 8;8(2):rkae040. doi: 10.1093/rap/rkae040. eCollection 2024.
PubMed 38618141Murphy SL, Chen YT, Alore M, Hicks S, Pape A, Hassett AL, Kratz AL, Whibley D, Harper AE, Huang S, Jay G, Bolde S, Khanna D. Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2024 Mar;76(3):318-327. doi: 10.1002/acr.25253. Epub 2024 Jan 12.
PubMed 37846437
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RENEW Scleroderma: A Peer-Mentored, Web Intervention for Resilience-based, Energy Management to Enhance Wellbeing and Fatigue
- ClinicalTrials.gov ID
- NCT04908943
- Acronym / sponsor ID
- RENEW / HUM00195121
- Conditions
- Scleroderma
- Keywords
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Rheumatology Research Foundation
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 1 Jun 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.
The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) | Experimental | Behavioral: RENEWRENEW was created by researchers, doctors, and patients with scleroderma. It is a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. |
| Waitlist | No intervention | –Participants will be asked about changes in health status, and use of any new treatments or services at 6 and 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of Systemic Sclerosis (SSc), any subtype
- Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9
- Have access to a computer and an internet connection
- Are able to speak and read English.
Key exclusion criteria (2 listed)
- Currently undergoing structured rehabilitation or psychological treatment.
- Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
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 |
|---|---|---|
| RENEWRENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being. | Behavioural | Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) |
Primary outcome
Change in Fatigue
Time frame: Up to 12 weeks
Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue.
3 secondary outcomes
Change in Pain Interference
Time frame: Up to 12 weeks
Change in Resilience
Time frame: Up to 12 weeks
Change in Depressive symptoms
Time frame: Up to 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 30 Nov 2023.
- Derived from this study: PubMed 38910596Chen YT, Hassett AL, Khanna D, Murphy SL. Resilience partially mediates the association between perceived social isolation and life satisfaction in people with systemic sclerosis. J Scleroderma Relat Disord. 2024 Jun;9(2):154-161. doi: 10.1177/23971983241232853. Epub 2024 Mar 5.
- Derived from this study: PubMed 38622109Chen YT, Hassett AL, Huang S, Khanna D, Murphy SL. Peer-Led Symptom Management Intervention to Enhance Resilience in People With Systemic Sclerosis: Mediation Analysis From a Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1278-1286. doi: 10.1002/acr.25352. Epub 2024 May 31.
- Derived from this study: PubMed 38618141Chen YT, Harper AE, Phanhdone T, Alore M, Hicks S, Pape A, Jay GM, Bolde S, Feldpausch J, Guetterman TC, Khanna D, Murphy SL. Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study. Rheumatol Adv Pract. 2024 Mar 8;8(2):rkae040. doi: 10.1093/rap/rkae040. eCollection 2024.
- Derived from this study: PubMed 37846437Murphy SL, Chen YT, Alore M, Hicks S, Pape A, Hassett AL, Kratz AL, Whibley D, Harper AE, Huang S, Jay G, Bolde S, Khanna D. Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2024 Mar;76(3):318-327. doi: 10.1002/acr.25253. Epub 2024 Jan 12.
- Individual participant dataSharing planned: Yes. Individual participant de-identified data that underlie the results reported in the article will be shared with researchers who present a methodologically sound proposal.
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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 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 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 4 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 30 Nov 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 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?
Change in Fatigue (time frame: Up to 12 weeks). 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 NCT04908943, which also lists 4 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 30 Nov 2023.