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Related Concept Videos

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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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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The Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program: protocol for a two-arm

Julia Nordlund1, Richard S Henry1,2, Linda Kwakkenbos3,4

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Summary

This study tests a revised Systemic Sclerosis (SSc) self-management program, the SPIN-SELF Program, delivered via group videoconference. The program aims to improve self-efficacy and other health outcomes for SSc patients.

Keywords:
Patient activationRandomized controlled trialSclerodermaSelf-efficacySelf-managementSystemic sclerosise-Health

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Area of Science:

  • Rheumatology
  • Autoimmune Diseases
  • Health Services Research

Background:

  • Systemic sclerosis (SSc), a rare autoimmune connective tissue disease, presents challenges in patient self-management.
  • Previous feasibility trials indicated low uptake for an online self-administered Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.
  • A revised, group-based SPIN-SELF Program incorporating facilitator-led videoconference sessions will be tested in a new feasibility trial.

Purpose of the Study:

  • To assess the feasibility of a group-based SPIN-SELF Program for Systemic Sclerosis (SSc) patients.
  • To evaluate the revised intervention delivery format for potential progression to a full-scale randomized controlled trial (RCT).
  • To determine the effect of the SPIN-SELF Program on disease management self-efficacy and other patient-reported outcomes.

Main Methods:

  • A feasibility trial using a two-arm, partially nested RCT design will recruit SSc patients with low to moderate self-efficacy.
  • Participants (n=40) will be randomized (1:1) to the group-based SPIN-SELF Program or usual care for 3 months.
  • Feasibility will be assessed using pre-defined criteria to determine progression to a full-scale RCT (n=524).

Main Results:

  • The primary outcome for the full-scale trial is disease management self-efficacy (SEMCD Scale) at 3 months post-randomization.
  • Secondary outcomes include SEMCD scores at 6 months, patient activation, social appearance anxiety, and functional health outcomes at 3 and 6 months.
  • Stoppage criteria will guide modifications to trial procedures or the SPIN-SELF Program before initiating the full-scale RCT.

Conclusions:

  • The group-based SPIN-SELF Program shows potential for improving disease management self-efficacy in SSc patients.
  • The program may also positively impact patient activation, social appearance anxiety, and functional health outcomes.
  • SPIN collaborates with international patient organizations to offer its programs freely.