SclerodermaSPIN-SELF-FNCT03914781
SPIN Self-Management Feasibility Trial
A study testing SPIN-SELF Program in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute at 1 site in Canada.
Trial summary
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the United Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic Sclerosis
- What is being tested?
- SPIN-SELF Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2019to 25 Nov 2019
- 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
- SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English, French or Spanish.
- For the feasibility trial, eligible patients must be able to use the online intervention in English, have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7), have indicated high interest in using an online self-management intervention (≥6 on 0-10 scale).
Who cannot join
- Patients not able to access or respond to questionnaires via the internet are excluded.
- Participants who are currently participating in another SPIN intervention trial and have not yet completed their final assessment measures will be excluded.
- French and Spanish speaking participants will be excluded from the feasibility trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Trial of an Internet-based Self-management Program to Improve Disease-management Self-efficacy in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the United Kingdom. The objectives of SPIN are (1) to assemble a large cohort of SSc patients who complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage problems related to SSc, including a self-management program (SPIN-SELF Program).
In the SPIN-SELF feasibility trial, eligible SPIN Cohort participants will be randomized to be offered the SPIN-SELF Program (in addition to usual care) or to usual care only. The SPIN-SELF Program was designed by SPIN members based on key tenets of behaviour change that have been successfully incorporated in programs for more common diseases and on patient input. It utilizes social modelling through educational videos of SSc patients describing their challenges and what they have done to cope with SSc, as well as videos teaching key self-management techniques. After an introduction to self-management and instructions on how to navigate the program, a short quiz comprised of one-item questions will direct patients to modules that are most relevant to their symptoms and disease management challenges. The program's modules address (1) pain; (2) skin care, finger ulcers, and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) emotions and stress; (8) body image concerns due to disfigurement; and (9) effective communication with healthcare providers.
The aim of the SPIN-SELF feasibility study is to collect data to assess the feasibility of planned procedures for the full-scale trial; required resources; and scientific aspects of the study (e.g., withdrawal rate, outcomes measures). These data will be used to determine whether it is feasible to carry out the main trial or whether changes need to be made before conducting a full-scale RCT of the SPIN-SELF Program.
Read the detailed description
The SPIN Cohort currently includes over 1800 SSc patients from 41 sites in Canada, the United States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN Cohort participants complete outcome measures via the Internet upon enrolment and subsequently every three months. SPIN utilizes the cohort multiple RCT (cmRCT) design as a framework for conducting trials of interventions. SPIN Cohort participants consent to allow personal data to be used for observational research, to assess intervention trial eligibility and, if eligible, to be randomized. Participants also consent that, if eligible and randomized to usual care, the participants' data can be used to evaluate intervention effectiveness without the participants being notified that they have been randomized to the usual care group and not offered the intervention. Thus, in SPIN trials, trial status is masked for participants in the control arm, who are not aware that they are participating in the trial, but not for participants in the intervention arm. The investigative team does not interact with patients for care provision or outcome assessment, which are done automatically via the internet.
The SPIN-SELF feasibility study is embedded in the SPIN Cohort and will evaluate the feasibility of conducting a full-scale RCT of the SPIN-SELF Program. Investigators will randomize 40 SPIN Cohort participants with low disease management self-efficacy and an indicated interest in using an online self-management program to be offered the SPIN-SELF Program or usual care only.
Randomization will occur at the time of participants' regular SPIN Cohort assessments. Eligible participants, based on questionnaire responses, will be randomized automatically using simple 3:2 randomization, using a feature in the SPIN Cohort platform, which provides immediate randomization and complete allocation sequence concealment.
Feasibility outcomes include participant eligibility and recruitment, and numbers and percentages of participants who do not respond to follow-up measures. Use of the online intervention will be described by presenting the frequency of logins and time spent on the SPIN-SELF Program. Analysis of outcome measures will include the completeness of data and presence of floor or ceiling effects. Descriptive statistics will be used to provide means and standard deviations for the measures. Qualitative information and information related to management and usability of the SPIN-SELF Program will inform any necessary changes to the intervention or trial procedures.
- Conditions
- Scleroderma, Systemic Sclerosis
- Being tested
- SPIN-SELF Program
- Keywords
- Scleroderma, Systemic Sclerosis, Self-management, E-health, Intervention
- 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.
SPIN-SELF ProgramBehavioural
The SPIN-SELF program utilizes social modelling through educational videos of scleroderma patients who describe their own challenges and what they have done to cope with living with scleroderma, as well as videos of patients and health professionals who teach key self-management techniques. The program includes sections on general self-management skills, including goal-setting and self-monitoring), progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with using self-management techniques to cope with SSc symptoms. The program's 9 modules focus on (1) coping with pain; (2) skin care, finger ulcers and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) managing emotions and stress; (8) coping with body image concerns due to disfigurement; and (9) effective communication with healthcare providers.
| Study group | Role | What they receive |
|---|---|---|
| SPIN-SELF program | Experimental | Offered access to the online SPIN-SELF program in addition to usual care Receives: Behavioral: SPIN-SELF Program |
| Not Offered the SPIN-SELF program | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility: Number of patients in the SPIN Cohort who meet the cut-off thresholds for eligibility
Measure: count of eligible patients
Measured: Baseline
Enrolment: Percentage of patients who consent to participation
Measure: count of consenting patients
Measured: Baseline
Participant feedback on usability
Participant interviews
Measured: 3 months
Intervention use: Number of logins and time spent on the SPIN-SELF program
Measure: usage log data
Measured: 3 months
Usage log data: Completeness of the automatic usage log data values collected
Measure: usage log data
Measured: 3 months
Usage log data: Linking of data from the SPIN Cohort and SPIN-SELF platforms
Measure: usage log data
Measured: 3 months
Technological problems
Measure: count of technological problems reported by staff and participants
Measured: 3 months
Secondary outcomes (2)
Self-Efficacy for Managing Chronic Disease (SEMCD) Scale
The 6-item SEMCD Scale measures self-efficacy among patients with chronic medical conditions by asking them to rate their confidence that they can perform certain tasks related to managing their disease. Items are rated on a numerical scale ranging from 1 (not confident at all) to 10 (totally confident). The score for the scale is the mean of all item scores, with higher scores reflecting greater self-efficacy
Measured: Baseline, 3 months
Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0
Measures 8 domains of health status with 4 items for each of 7 domains (physical function, anxiety, depression, fatigue, sleep disturbance, social roles and activities, pain interference) plus a single item for pain intensity. Items are scored on a 5-point scale (range 1-5), with different response options for different domains, and the single pain intensity item is measured on an 11-point rating scale. Higher scores represent more of the domain being measured
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start5 Jul 2019
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
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 SclerodermaStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett D Thombs, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914781
- Sponsor's protocol ID
- 2019-1146
- Acronym
- SPIN-SELF-F
- Status last verified
- Jan 2020
- First submitted
- 10 Apr 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request
Publications
Kwakkenbos L, Ostbo N, Carrier ME, Nielson WR, Fedoruk C, Levis B, Henry RS, Pope J, Frech T, Gholizadeh S, Johnson SR, Piotrowski P, Jewett LR, Gordon J, Chung L, Bilsker D, Tao L, Turner KA, Cumin J, Welling J, Fortune C, Leite C, Gottesman K, Sauve M, Reyna TSR, Hudson M, Larche M, van Breda W, Suarez-Almazor ME, Bartlett SJ, Malcarne VL, Mayes MD, Boutron I, Mouthon L, Benedetti A, Thombs BD; SPIN Investigators. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program. Pilot Feasibility Stud. 2022 Feb 26;8(1):45. doi: 10.1186/s40814-022-00994-5.
PubMed 35219340
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of an Internet-based Self-management Program to Improve Disease-management Self-efficacy in Patients With Scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Study
- ClinicalTrials.gov ID
- NCT03914781
- Acronym / sponsor ID
- SPIN-SELF-F / 2019-1146
- Conditions
- Scleroderma, Systemic Sclerosis
- Keywords
- Scleroderma, Systemic Sclerosis, Self-management, E-health, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 16 Apr 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.
The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma (systemic sclerosis; SSc) from Canada, the United States, Mexico, Australia, France, Spain, and the United Kingdom. The objectives of SPIN are (1) to assemble a large cohort of SSc patients who complete outcome assessments regularly in order to learn more about important problems faced by people living with SSc and (2) to develop and test a series of internet-based interventions to help patients manage problems related to SSc, including a self-management program (SPIN-SELF Program).
In the SPIN-SELF feasibility trial, eligible SPIN Cohort participants will be randomized to be offered the SPIN-SELF Program (in addition to usual care) or to usual care only. The SPIN-SELF Program was designed by SPIN members based on key tenets of behaviour change that have been successfully incorporated in programs for more common diseases and on patient input. It utilizes social modelling through educational videos of SSc patients describing their challenges and what they have done to cope with SSc, as well as videos teaching key self-management techniques. After an introduction to self-management and instructions on how to navigate the program, a short quiz comprised of one-item questions will direct patients to modules that are most relevant to their symptoms and disease management challenges. The program's modules address (1) pain; (2) skin care, finger ulcers, and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) emotions and stress; (8) body image concerns due to disfigurement; and (9) effective communication with healthcare providers.
The aim of the SPIN-SELF feasibility study is to collect data to assess the feasibility of planned procedures for the full-scale trial; required resources; and scientific aspects of the study (e.g., withdrawal rate, outcomes measures). These data will be used to determine whether it is feasible to carry out the main trial or whether changes need to be made before conducting a full-scale RCT of the SPIN-SELF Program.
Detailed description
The SPIN Cohort currently includes over 1800 SSc patients from 41 sites in Canada, the United States, Mexico, Australia, and France, Spain, and the United Kingdom. SPIN Cohort participants complete outcome measures via the Internet upon enrolment and subsequently every three months. SPIN utilizes the cohort multiple RCT (cmRCT) design as a framework for conducting trials of interventions. SPIN Cohort participants consent to allow personal data to be used for observational research, to assess intervention trial eligibility and, if eligible, to be randomized. Participants also consent that, if eligible and randomized to usual care, the participants' data can be used to evaluate intervention effectiveness without the participants being notified that they have been randomized to the usual care group and not offered the intervention. Thus, in SPIN trials, trial status is masked for participants in the control arm, who are not aware that they are participating in the trial, but not for participants in the intervention arm. The investigative team does not interact with patients for care provision or outcome assessment, which are done automatically via the internet.
The SPIN-SELF feasibility study is embedded in the SPIN Cohort and will evaluate the feasibility of conducting a full-scale RCT of the SPIN-SELF Program. Investigators will randomize 40 SPIN Cohort participants with low disease management self-efficacy and an indicated interest in using an online self-management program to be offered the SPIN-SELF Program or usual care only.
Randomization will occur at the time of participants' regular SPIN Cohort assessments. Eligible participants, based on questionnaire responses, will be randomized automatically using simple 3:2 randomization, using a feature in the SPIN Cohort platform, which provides immediate randomization and complete allocation sequence concealment.
Feasibility outcomes include participant eligibility and recruitment, and numbers and percentages of participants who do not respond to follow-up measures. Use of the online intervention will be described by presenting the frequency of logins and time spent on the SPIN-SELF Program. Analysis of outcome measures will include the completeness of data and presence of floor or ceiling effects. Descriptive statistics will be used to provide means and standard deviations for the measures. Qualitative information and information related to management and usability of the SPIN-SELF Program will inform any necessary changes to the intervention or trial procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPIN-SELF program | Experimental | Behavioral: SPIN-SELF ProgramOffered access to the online SPIN-SELF program in addition to usual care |
| Not Offered the SPIN-SELF program | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- SPIN Cohort patients must have a systemic sclerosis (SSc) diagnosis based on 2013 American College of Rheumatology/European League Against Rheumatism criteria confirmed by a SPIN physician, be ≥18 years old, be able to give informed consent, and be fluent in English, French or Spanish.
- For the feasibility trial, eligible patients must be able to use the online intervention in English, have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7), have indicated high interest in using an online self-management intervention (≥6 on 0-10 scale).
Key exclusion criteria (3 listed)
- Patients not able to access or respond to questionnaires via the internet are excluded.
- Participants who are currently participating in another SPIN intervention trial and have not yet completed their final assessment measures will be excluded.
- French and Spanish speaking participants will be excluded from the feasibility trial.
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 |
|---|---|---|
| SPIN-SELF ProgramThe SPIN-SELF program utilizes social modelling through educational videos of scleroderma patients who describe their own challenges and what they have done to cope with living with scleroderma, as well as videos of patients and health professionals who teach key self-management techniques. The program includes sections on general self-management skills, including goal-setting and self-monitoring), progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with using self-management techniques to cope with SSc symptoms. The program's 9 modules focus on (1) coping with pain; (2) skin care, finger ulcers and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) managing emotions and stress; (8) coping with body image concerns due to disfigurement; and (9) effective communication with healthcare providers. | Behavioural | SPIN-SELF program |
Primary outcome
Eligibility: Number of patients in the SPIN Cohort who meet the cut-off thresholds for eligibility
Time frame: Baseline
Measure: count of eligible patients
Enrolment: Percentage of patients who consent to participation
Time frame: Baseline
Measure: count of consenting patients
Participant feedback on usability
Time frame: 3 months
Participant interviews
Intervention use: Number of logins and time spent on the SPIN-SELF program
Time frame: 3 months
Measure: usage log data
Usage log data: Completeness of the automatic usage log data values collected
Time frame: 3 months
Measure: usage log data
Usage log data: Linking of data from the SPIN Cohort and SPIN-SELF platforms
Time frame: 3 months
Measure: usage log data
Technological problems
Time frame: 3 months
Measure: count of technological problems reported by staff and participants
2 secondary outcomes
Self-Efficacy for Managing Chronic Disease (SEMCD) Scale
Time frame: Baseline, 3 months
Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0
Time frame: Baseline, 3 months
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 28 Jan 2020.
- Derived from this study: PubMed 35219340Kwakkenbos L, Ostbo N, Carrier ME, Nielson WR, Fedoruk C, Levis B, Henry RS, Pope J, Frech T, Gholizadeh S, Johnson SR, Piotrowski P, Jewett LR, Gordon J, Chung L, Bilsker D, Tao L, Turner KA, Cumin J, Welling J, Fortune C, Leite C, Gottesman K, Sauve M, Reyna TSR, Hudson M, Larche M, van Breda W, Suarez-Almazor ME, Bartlett SJ, Malcarne VL, Mayes MD, Boutron I, Mouthon L, Benedetti A, Thombs BD; SPIN Investigators. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program. Pilot Feasibility Stud. 2022 Feb 26;8(1):45. doi: 10.1186/s40814-022-00994-5.
- Individual participant dataSharing planned: Yes. Upon request
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Scleroderma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPIN-SELF Program in people with Scleroderma and Systemic Sclerosis, run by Lady Davis Institute 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 2 inclusion and 3 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 28 Jan 2020. 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?
Eligibility: Number of patients in the SPIN Cohort who meet the cut-off thresholds for eligibility (time frame: Baseline). The study lists 7 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 NCT03914781, 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 28 Jan 2020.