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Feasibility, usability and implementation context of an internet-based pain education and exercise program for chronic musculoskeletal pain: a pilot trial of the REABILITADOR program
Fioratti I, Miyamoto GC, Fandim JV, Ribeiro CPP, Batista GD, Freitas GE, Palomo AS, Reis F, Costa LOP, Maher CG, Saragiotto BT
JMIR Formative Research 2022 Aug;6(8):e35743
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Internet-based self-management programs and telerehabilitation initiatives have grown with the development of new technologies and have been extensively used for delivering healthcare in many areas. These programs overcome common barriers that patients face with traditional face-to-face healthcare, such as travel, lack of time, and high demand on the public health system. In the past years, during the emergence of the COVID-19 pandemic, this mode of delivery has become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility and factors involved in the implementation of an online program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable and adequate for its purposes and optimising resource allocation. OBJECTIVE: To evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (Reabilitador) in people with chronic musculoskeletal pain compared with an online self-management booklet. METHODS: DESIGN: Parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomised controlled trial with economic evaluation. SETTINGS: Waiting lists of physiotherapy and rehabilitation centres and advertisements on social media networks. PARTICIPANTS: 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. INTERVENTIONS: A 8-week telerehabilitation program based on exercises and pain education (intervention group) compared with an online self-management booklet (control group). MAIN OUTCOME MEASURES: Implementation outcomes of patient's perceptions of acceptability, appropriateness, feasibility, and usability of the program; societal costs and feasibility to the main trial at 8-week post-treatment follow-up. Adverse events were also analysed. RESULTS: 56 participants were analysed at the 8-week follow-up. The intervention group showed responses with a mean (SD) of 4.5 points (0.62) for acceptability, 4.5 points (0.5) for appropriateness and 4.5 points (0.57) for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence of the feasibility of the main trial. For costs spending related to the interventions, healthcare, patients, and loss of productivity at 8 weeks, we found a total expend of US$278.3 per patient in the intervention group and US$141.52 per patient expended in the control group. No adverse events were reported during the intervention period. CONCLUSIONS: We found that the Reabilitador program is feasible, appropriate, and acceptable from the users' implementation perspective. The system has been considered usable by all participants and the main trial seems feasible. Cost data were viable to be collected and the program is likely to be safe. Both groups reported being satisfied with the platform and the proposed program content. CLINICALTRIAL: Nct04274439.

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