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Feasibility of an electronic health tool to promote physical activity in primary care: pilot cluster randomized controlled trial
Agarwal P, Kithulegoda N, Bouck Z, Bosiak B, Birnbaum I, Reddeman L, Steiner L, Altman L, Mawson R, Propp R, Thornton J, Ivers N
Journal of Medical Internet Research 2020 Feb;22(2):e15424
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; 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: Physical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common. Objective: This study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients' PA levels. METHODS: A pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory. RESULTS: A total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention (n = 296) and control (n = 234)). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non-statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1,027; 95% CI -155 to 2,209; p = 0.09). No statistically significant differences were observed for secondary outcomes. CONCLUSIONS: Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data. TRIAL REGISTRATION: ClinicalTrials.gov NCT03181295; https://ClinicalTrials.gov/ct2/show/NCT03181295.

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