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Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

ABSTRACT: INTRODUCTION:Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD. METHODS AND ANALYSIS:The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.

SUBMITTER: Rezvani F

PROVIDER: S-EPMC7279623 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

Rezvani Farhad F Heider Dirk D Härter Martin M König Hans-Helmut HH Bienert Frank F Brinkmann Julia J Herbarth Lutz L Kramer Edith E Steinisch Patrick P Freudenstein Frank F Terhalle René R Grosse Yvonne Y Bock Susanne S Posselt Jacqueline J Beutel Corinna C Reif Franziska F Kirchhoff Florian F Neuschwander Carolin C Löffler Franziska F Brunner Lisa L Dickmeis Patrick P Heidenthal Thomas T Schmitz Lara L Chase Daniela Patricia DP Seelenmeyer Claudia C Alscher Mark Dominik MD Tegtbur Uwe U Dirmaier Jörg J

BMJ open 20200604 6

<h4>Introduction</h4>Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exe ...[more]

PMID: 32503866

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Project description:Importance:Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. Objective:To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months in patients with PAD. Design, Setting, and Participants:Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. Interventions:The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. Main Outcomes and Measures:The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. Results:Among 200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P = .31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P = .002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. Conclusions and Relevance:Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD. Trial Registration:clinicaltrials.gov Identifier: NCT02462824.

Project description:OBJECTIVE:To assess whether telephone coaching is a cost-effective method for increasing physical activity and health-related quality of life for insufficiently active adults presenting to an ambulatory care clinic in a public hospital. DESIGN:An economic evaluation was performed alongside a randomised controlled trial. SETTING:Participants were recruited from an ambulatory care clinic in a public hospital in regional Australia. PARTICIPANTS:Seventy-two adults (aged 18-69) deemed insufficiently physically active via self-report. INTERVENTIONS:Participants were randomised to either an intervention group that received an education session and eight sessions of telephone coaching over a 12-week period, or to a control group that received the education session only. The intervention used in the telephone coaching was integrated motivational interviewing and cognitive behavioural therapy. OUTCOME MEASURES:The primary health outcome was change in moderate-to-vigorous physical activity (MVPA), objectively measured via accelerometry. The secondary outcome was the quality-adjusted life-year (QALY) determined by the 12-item Short Form Health Survey Questionnaire. Outcome data were measured at baseline, postintervention (3 months) and follow-up (6 months). Incremental cost-effectiveness ratios (ICERs) were calculated for each outcome. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS:The mean intervention cost was $279±$13 per person. At 6 months follow-up, relative to control, the intervention group undertook 18 more minutes of daily MVPA at an ICER of $15/min for each additional minute of MVPA. With regard to QALYs, the intervention yielded an ICER of $36 857 per QALY gained. Sensitivity analyses indicated that results were robust to varied assumptions. CONCLUSION:Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients. Additional research could explore the potential economic impact of the intervention from a broader healthcare perspective. TRIAL REGISTRATION NUMBER:ANZCTR: ACTRN12616001331426.

Dataset Information

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

Publications

Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.

Similar Datasets

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