Three-week inpatient energy management education (IEME) for persons with multiple sclerosis–related fatigue. A feasibility study
- Conditions
- G35Multiple sclerosis
- Registration Number
- DRKS00011634
- Lead Sponsor
- Rehabilitationszentrum Valens
- Brief Summary
Background: Multiple sclerosis (MS)-related fatigue limits participation in everyday activities and has a considerable impact on quality of life (QoL), thereby affecting productivity and employment. Outpatient education interventions involving energy conservation strategies and cognitive behavioral therapy techniques are helpful. However, no inpatient program is currently available. The inpatient energy management education (IEME) program is a novel group-based intervention that lasts for 6.5 h and is conducted by a trained occupational therapist (OT) during a 3-week period of inpatient rehabilitation. Persons with MS (pwMS) and OTs previously evaluated the IEME positively in a pilot study test run. The aim of this study was to evaluate the feasibility of a research protocol and collect preliminary data on the IEME effect size. Methods: To assess the feasibility of conducting a randomized clinical trial, pwMS-related fatigue were recruited during a 3-week inpatient rehabilitation. Six IEME (experimental) group sessions or progressive muscle relaxation (PMR, control) group sessions comprised part of a personalized rehabilitation program. The recruitment and assessment procedures, dropout and follow-up assessment rates and the treatment fidelity were evaluated, and six telephone interviews were conducted with IEME participants after they returned home. Outcomes were fatigue impact, occupational performance, self-efficacy regarding energy conservation strategies, and QoL at baseline, discharge, and 4 months. Paired-sample and independent-samples t-tests were used to assess withinand between-group effects. Effect sizes were estimated using Cohen's d. Results: Between August and November 2017, 47 pwMS were included and randomized. The dropout rate (4.2%) was low and the sample was balanced. The PMR was a well-accepted control intervention. The OTs reported no problems in conducting the IEME, and treatment fidelity was high. IEME participants confirmed the adequacy of the IEME. Within-group differences in fatigue impact and some QoL dimensions at discharge were significant (p < 0.05) in both groups. The IEME alone resulted in significant improvements in self-efficacy regarding energy conservation strategies, with a large effect size (Cohen's d: 1.32; 95% CI: 0.54–2.1), and in the QoL physical functioning dimension at T2 (Cohen's d: 1.32; 95% CI: 2.11–0.53). IEME participants spent significantly less time in individual OT sessions. A sample size of 192 participants in a randomized controlled trial would be sufficient to detect clinically relevant between-group differences. Conclusion: This feasibility study has provided promising preliminary data about the effect of the IEME. The research protocol was confirmed to be feasible and a future study is justified.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 47
The inclusion criteria for the participants’ eligibility are a minimum three-week inpatient rehabilitation period and definite MS diagnosis.
>18 years,
Fatigue severity scale 6 (FSS) score >4,
Expanded disability status scale 7 (EDSS) =6.5,
Insufficient knowledge of the project language (German)
Reduced cognitive capacity; telephone mini-mental state examination (tMMSE) =21
Depression; Beck depression inventory for fast screening (BDI-FS) >4
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1:<br>We evaluate the satisfaction of patients with the inpatient energy management education (IEME) conducting a focus group (duration 60 min.)<br>We evaluate the compliance of OTs during the IEME conducting a focus group (duration 60 min.) and the and adherence with fidelity checklists.<br>Part 2 <br>We evaluate recruitment, drop out and follow-up rate and document the recruitment process<br>We use five different self-assessments questionnaires at baseline, at week three (end of interventions) and week 19 (follow up) to calculate meaningful change in outcome measurements. <br>Modified fatigue impact scale (MFIS),<br>Occupational self-assessment(OSA), <br>Health related quality of life(SF36),<br>Self-efficacy scale(UW-SES), <br>Self-efficacy for performing energy conservation strategies assessment(SEPECSA).<br><br>
- Secondary Outcome Measures
Name Time Method not applicable