SPIN Self-Management Feasibility Trial

NCT03914781 | Completed

• 1 other identifier: 2019-1146
• Study Type: interventional
• Target: 40
• 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). 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.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Eligibility: Number of patients in the SPIN Cohort who meet the cut-off thresholds for eligibility

  Measure: count of eligible patients

  Baseline

• Enrolment: Percentage of patients who consent to participation

  Measure: count of consenting patients

  Baseline

• Participant feedback on usability

  Participant interviews

  3 months

• Intervention use: Number of logins and time spent on the SPIN-SELF program

  Measure: usage log data

  3 months

• Usage log data: Completeness of the automatic usage log data values collected

  Measure: usage log data

  3 months

• Usage log data: Linking of data from the SPIN Cohort and SPIN-SELF platforms

  Measure: usage log data

  3 months

• Technological problems

  Measure: count of technological problems reported by staff and participants

  3 months

Secondary Outcomes (2)

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

  Baseline, 3 months

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

  Baseline, 3 months

Study Arms (2)

SPIN-SELF program

EXPERIMENTAL

Offered access to the online SPIN-SELF program in addition to usual care

Behavioral: SPIN-SELF Program

Not Offered the SPIN-SELF program

NO INTERVENTION

Usual care

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.

SPIN-SELF program

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, 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).

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.

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3S 1Y9, Canada

Location

Related Publications (1)

• 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.

  PMID: 35219340 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, Lady Davis Institute for Medical Research, Jewish General Hospital

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: July 5, 2019
• Primary Completion: November 25, 2019
• Study Completion: November 25, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)