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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Author Spotlight: Methodologies and Advancements of Chronic Pain Management Research
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The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a Randomized Feasibility

Marie-Eve Carrier1, Linda Kwakkenbos2, Warren R Nielson3

  • 1Lady Davis Institute of the Jewish General Hospital, Montreal, QC, Canada.

JMIR Research Protocols
|April 25, 2020
PubMed
Summary
This summary is machine-generated.

This study tested the feasibility of a web-based self-management program for Systemic Sclerosis (SSc). The results will inform a larger trial to improve self-efficacy and quality of life for SSc patients.

Keywords:
feasibility studiesscleroderma, systemicself-managementtrial protocols

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Area of Science:

  • Rheumatology
  • Digital Health
  • Health Services Research

Background:

  • Systemic sclerosis (SSc) significantly impacts daily living and well-being.
  • Current SSc treatment focuses on symptom management and improving quality of life.
  • Web-based self-management programs show promise for enhancing self-efficacy in chronic diseases.

Purpose of the Study:

  • To assess the feasibility of a full-scale randomized controlled trial (RCT) for the SPIN-SELF program.
  • To evaluate implementation processes, resources, scientific aspects, and participant engagement.
  • To guide necessary adjustments before a large-scale RCT.

Main Methods:

  • A feasibility trial using the SPIN Cohort and a cohort multiple RCT design.
  • 40 SSc participants with low self-efficacy randomized (3:2) to SPIN-SELF or usual care for 3 months.
  • Feasibility outcomes included trial processes, resources, scientific validity, and user acceptability.

Main Results:

  • Participant enrollment completed between July 5-27, 2019.
  • Data collection concluded by November 25, 2019.
  • Data analysis is ongoing; results anticipated in 2020.

Conclusions:

  • The SPIN-SELF program may enhance self-management self-efficacy and HRQoL in SSc patients.
  • The feasibility trial ensures robust and acceptable trial methodology.
  • Findings will inform adjustments for a future full-scale RCT.