Scleroderma Patient-centered Intervention Network (SPIN) Hand Program Feasibility Study

Summary

The Scleroderma Patient-centered Intervention Network (SPIN) is an organization established by researchers, health care providers, and people living with scleroderma from Canada, the USA, and Europe. The objectives of SPIN are (1) to assemble a large cohort of scleroderma patients to complete outcome assessments regularly in order to learn more about important problems faced by people living with scleroderma and (2) to develop and test a series of internet-based interventions to help patients manage aspects of scleroderma, including hand limitations.

In the SPIN-HAND feasibility trial, SPIN Cohort participants with at least mild hand function limitations and an indicated interest in using an online hand exercise program will be randomized to be offered the SPIN hand exercise program or to usual care only. The core SPIN hand exercise program consists of 4 modules that address specific aspects of hand function, including Thumb Flexibility and Strength; Finger Bending; Finger Extension; and Wrist Flexibility and Strength. The program also integrates tools to support key components of successful self-management programs, including goal-setting.

The aim of the SPIN-HAND feasibility study is to collect data to assess the feasibility of the steps that need to take place as part of the main trial; required resources; and scientific aspects (e.g., withdrawal rate, outcomes measures). Data will be used to determine whether it is feasible to carry out the main study or whether changes need to be made before conducting a full-scale RCT of the SPIN-HAND program.

Conditions

• Scleroderma
• Systemic Sclerosis

Interventions

OTHER

SPIN-HAND program

The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.

Sponsors & Collaborators

• Hôpital Cochin

  collaborator OTHER

• Lady Davis Institute

  lead OTHER

Principal Investigators

• Luc Mouthon, MD, PhD · Hôpital Cochin, Paris, France

• Serge Poiraudeau, MD, PhD · Hôpital Cochin, Paris, France

• Brett Thombs, PhD · Lady Davis Institute, Montreal, Quebec, Canada

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-01

Primary Completion

2017-10-17

Completion

2017-10-17

Countries

• Canada

Study Locations