Background <p>The Spinal Cord Injury and You (SCI&amp;U) intervention aims to improve self-management skills for persons living with SCI using a web-based, peer health-coaching model. This study assessed feasibility of a future definitive trial of SCI&amp;U, specifically feasibility of recruitment and retention, program usability and quality, effect size estimates for self-management outcomes and rehospitalisation rates (i.e. health-related quality of life).</p> Methods <p>A two-group, randomised, controlled, pilot trial with prospective recruitment, concealed group allocation, blinded outcome evaluation and waitlist control was conducted. We aimed to recruit 60 adult participants living in the community at least 6&#xa0;months post-injury who could speak and read English and had a family physician. The intervention included up to 14 1-h online client-coach videoconferencing sessions, goal setting, action planning and a sortable resource library. Data were collected at baseline, 2, 6 and 12&#xa0;months post-randomisation. SCI&amp;U was offered to waitlist participants at 12&#xa0;months.</p> Results <p>Trial methodology and procedures were feasible. Recruitment and retention targets were achieved. Individuals were randomised to intervention (<i>n</i> = 31) and waitlist control (<i>n</i> = 34). Mean time since SCI was 25.6&#xa0;years (intervention) and 20.2&#xa0;years (control). Timeline for completion of online sessions was extended from 2 months to 6&#xa0;months. Outcome data were gathered for 86% (6&#xa0;months) and 89% (12&#xa0;months) of participants. Program usability and quality were highly rated on the Mobile App Rating Scale. Difference in Skill and Technique Acquisition subscale between intervention and control was 0.56 (95%CI -0.41, 1.52) at 6&#xa0;months and 0.72 (95%CI -0.28, 1.72) at 12&#xa0;months. Other Health Education Impact Questionnaire subscales had large effect sizes: self-monitoring and insight 1.51 (95% CI 0.39, 2.69); emotional distress -1.40 (95%CI -3.04, 0.23). In 12&#xa0;months post-recruitment, 5 intervention and 4 control participants spent median 11 (95% CI 3-19) and 24 (95% CI 5-95) nights in hospital, respectively.</p> Conclusions <p>Trial methodology and procedures were feasible. The SCI&amp;U intervention was acceptable to participants and positively impacted an individual’s ability to self-manage. A definitive trial is warranted to build on these findings, particularly in those with recently acquired SCI. Future recruitment efforts will focus on inpatient rehabilitation hospitals to recruit individuals &lt; 5&#xa0;years post-injury.</p> Trial registration <p>ClinicalTrials.gov, NCT04474171, retrospectively registered 07/13/2020; <a href="https://clinicaltrials.gov/study/NCT04474171#study-record-dates">https://clinicaltrials.gov/study/NCT04474171#study-record-dates</a>.</p>

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A pilot randomised controlled trial of the Spinal Cord Injury and You (SCI&U) online peer health coaching self-management program

  • Susan B. Jaglal,
  • Sonya J. Allin,
  • B. Catharine Craven,
  • Sara J. T. Guilcher,
  • A. Gary Linassi,
  • Christopher B. McBride,
  • Rahim Moineddin,
  • W. Ben Mortenson,
  • Sarah Munce,
  • Nancy M. Salbach,
  • John D. Shepherd,
  • Shane N. Sweet,
  • Teri Thorson,
  • Jennifer R. Tomasone

摘要

Background

The Spinal Cord Injury and You (SCI&U) intervention aims to improve self-management skills for persons living with SCI using a web-based, peer health-coaching model. This study assessed feasibility of a future definitive trial of SCI&U, specifically feasibility of recruitment and retention, program usability and quality, effect size estimates for self-management outcomes and rehospitalisation rates (i.e. health-related quality of life).

Methods

A two-group, randomised, controlled, pilot trial with prospective recruitment, concealed group allocation, blinded outcome evaluation and waitlist control was conducted. We aimed to recruit 60 adult participants living in the community at least 6 months post-injury who could speak and read English and had a family physician. The intervention included up to 14 1-h online client-coach videoconferencing sessions, goal setting, action planning and a sortable resource library. Data were collected at baseline, 2, 6 and 12 months post-randomisation. SCI&U was offered to waitlist participants at 12 months.

Results

Trial methodology and procedures were feasible. Recruitment and retention targets were achieved. Individuals were randomised to intervention (n = 31) and waitlist control (n = 34). Mean time since SCI was 25.6 years (intervention) and 20.2 years (control). Timeline for completion of online sessions was extended from 2 months to 6 months. Outcome data were gathered for 86% (6 months) and 89% (12 months) of participants. Program usability and quality were highly rated on the Mobile App Rating Scale. Difference in Skill and Technique Acquisition subscale between intervention and control was 0.56 (95%CI -0.41, 1.52) at 6 months and 0.72 (95%CI -0.28, 1.72) at 12 months. Other Health Education Impact Questionnaire subscales had large effect sizes: self-monitoring and insight 1.51 (95% CI 0.39, 2.69); emotional distress -1.40 (95%CI -3.04, 0.23). In 12 months post-recruitment, 5 intervention and 4 control participants spent median 11 (95% CI 3-19) and 24 (95% CI 5-95) nights in hospital, respectively.

Conclusions

Trial methodology and procedures were feasible. The SCI&U intervention was acceptable to participants and positively impacted an individual’s ability to self-manage. A definitive trial is warranted to build on these findings, particularly in those with recently acquired SCI. Future recruitment efforts will focus on inpatient rehabilitation hospitals to recruit individuals < 5 years post-injury.

Trial registration

ClinicalTrials.gov, NCT04474171, retrospectively registered 07/13/2020; https://clinicaltrials.gov/study/NCT04474171#study-record-dates.