SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)

NCT04246528 | Completed

• 1 other identifier: 2021-2777
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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. 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). 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, patients will have access 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 proposed study is a feasibility trial with progression to full-scale randomized controlled trial (RCT), depending on whether stoppage criteria are met, of the SPIN Self-Management Program. The SPIN-SELF Program was previously feasibility tested as an online only, self-help intervention. However, uptake was low, thus the investigators have moved to a group-based format. SPIN-SELF participants randomized to intervention will access and use online self-management material, and this will be supported by videoconference group sessions, led by trained peer facilitators. In the SPIN-SELF feasibility trial with progression to full-scale trial, the investigators will evaluate the disease management self-efficacy of participants who use SPIN-SELF compared to usual care. Eligible SPIN Cohort participants and externally recruited participants, with low disease-management self-efficacy, will be randomized to the SPIN-SELF Program or to usual care only. In the feasibility portion, 40 eligible participants will be randomized. Unless the trial team determines, based on stoppage criteria, that trial procedures need important modifications thereby re-setting the full scale trial as a new trial, the outcome data of the participants in the feasibility portion will be utilized in the analyses of the full-scale trial. In the full-scale RCT, 524 participants will be randomized.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Scleroderma; Self-management; E-health; Intervention; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (7)

• Self-Efficacy for Managing Chronic Disease (SEMCD) Scale

  6 months

• Patient Activation Measure (PAM-13)

  3 months, 6 months

• Social Appearance Anxiety Scale (SAAS)

  3 months, 6 months

• Patient Reported Outcomes Measurement Information System (PROMIS-29) profile version 2.0

  3 months, 6 months

• Participant Satisfaction: SPIN-SELF Program

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Access to the online SPIN-SELF program

Behavioral: SPIN-SELF Program

Control group

NO INTERVENTION

Usual care, no access to the online SPIN-SELF program

Interventions

SPIN-SELF Program BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, and have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7).
• For the full-scale trial, eligible patients must be able to use the online intervention in English or French, and have low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease (SEMCD) ≤ 7).

You may not qualify if:

• 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.
• Spanish speaking participants will be excluded from the full-scale trial.
• Participants in the feasibility trial will be excluded in the full-scale trial.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E3, Canada

Location

Related Publications (1)

• Nordlund J, Henry RS, Kwakkenbos L, Carrier ME, Levis B, Nielson WR, Bartlett SJ, Dyas L, Tao L, Fedoruk C, Nielsen K, Hudson M, Pope J, Frech T, Gholizadeh S, Johnson SR, Piotrowski P, Jewett LR, Gordon J, Chung L, Bilsker D, Levis AW, Turner KA, Cumin J, Welling J, Fortune C, Leite C, Gottesman K, Sauve M, Rodriguez-Reyna TS, Larche M, van Breda W, Suarez-Almazor ME, Wurz A, Culos-Reed N, Malcarne VL, Mayes MD, Boutron I, Mouthon L, Benedetti A, Thombs BD; SPIN Investigators. The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm parallel partially nested randomized controlled feasibility trial with progression to full-scale trial. Trials. 2021 Nov 27;22(1):856. doi: 10.1186/s13063-021-05827-z.

  PMID: 34838105 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: September 15, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the collection of the primary outcome
• Access Criteria: Approval of proposed purpose for data access

Locations

CA (1)