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; Heider, Dirk; Härter, Martin; König, Hans‐Helmut; Bienert, Frank; Brinkmann, Julia; Herbarth, Lutz; Kramer, Edith; Steinisch, Patrick; Freudenstein, Frank; Terhalle, René; Grosse, Yvonne; Bock, Susanne; Posselt, Jacqueline; Beutel, Corinna; Reif, Franziska; Kirchhoff, F.; Neuschwander, Carolin; Löffler, Franziska; Brunner, Lisa; Dickmeis, Patrick; Heidenthal, Thomas; Schmitz, Lara; Chase, Daniela; Seelenmeyer, Claudia; Alscher, Mark Dominik; Tegtbur, Uwe; Dirmaier, Jörg

doi:10.1136/bmjopen-2019-032146

Cited by 8 publications

(4 citation statements)

References 96 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We are aware that the balancing of randomized controlled trials and the interpretation of the results may seem controversial to some readers. That is why we chose to report the balanced analyses that were previously announced in the study protocol [ 31 ] less prominently as another form of sensitivity analysis. Nevertheless, we would argue that at least in our case, backed by the numbers, the randomization was successful though not perfect, when it comes to the mere mean baseline values.…”

Section: Discussionmentioning

confidence: 99%

“…Analyses were in accordance with the CONSORT guidelines and conducted by intention-to-treat (ITT), modified intention-to-treat (mITT), per protocol (PP) and as treated (AS) approaches. As outlined in the study protocol [ 31 ], unbalanced ITT was the main analysis. Patients randomized into the intervention group who did not follow the TeGeCoach-program as intended or discontinued it, or for whom no doctor could be named (i.e.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial

Heider,

Rezvani,

Matschinger

et al. 2023

Eur J Health Econ

Self Cite

View full text Add to dashboard Cite

Background Peripheral artery disease (PAD) is the third most prevalent atherosclerotic cardiovascular disease. In 2016, costs per patient associated with PAD exceeded even the health-economic burden of coronary heart disease. Although affecting over 200 million people worldwide, a clear consensus on the most beneficial components to be included in home-based exercise programs for patients with peripheral artery disease is lacking. The aim of the study was to examine the health care use and costs caused by the 12-month patient-centered ‘Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease’ (TeGeCoach) program in a randomized controlled trial. Methods This is a two-arm, parallel-group, open-label, pragmatic, randomized, controlled clinical trial (TeGeCoach) at three German statutory health insurance funds with follow-up assessments after 12 and 24-months. Study outcomes were medication use (daily defined doses), days in hospital, sick pay days and health care costs, from the health insurers’ perspective. Claims data from the participating health insurers were used for analyses. The main analytic approach was an intention-to-treat (ITT) analysis. Other approaches (modified ITT, per protocol, and as treated) were executed additionally as sensitivity analysis. Random-effects regression models were calculated to determine difference-in-difference (DD) estimators for the first- and the second year of follow-up. Additionally, existing differences at baseline between both groups were treated with entropy balancing to check for the stability of the calculated estimators. Results One thousand six hundred eighty-five patients (Intervention group (IG) = 806; Control group (CG) = 879) were finally included in ITT analyses. The analyses showed non-significant effects of the intervention on savings (first year: − 352€; second year: − 215€). Sensitivity analyses confirmed primary results and showed even larger savings. Conclusion Based on health insurance claims data, a significant reduction due to the home-based TeGeCoach program could not be found for health care use and costs in patients with PAD. Nevertheless, in all sensitivity analysis a tendency became apparent for a non-significant cost reducing effect. Trial registration NCT03496948 (www.clinicaltrials.gov), initial release on 23 March 2018

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial

Heider,

Rezvani,

Matschinger

et al. 2023

Eur J Health Econ

Self Cite

View full text Add to dashboard Cite

show abstract

“…pre-intervention) drawn from a larger data set that was collected as part of a multicenter, randomized-controlled trial (RCT) designed to test the effectiveness of a 12-month long telemedicine-guided home-based exercise program for patients with IC, PAD-TeGeCoach (CT.gov trial registration: NCT03496948). Methods of the PAD-TeGeCoach effectiveness trial are reported elsewhere in detail [ 37 ]. Ethical approval was granted by the ethics committee of the Medical Association of Hamburg.…”

Section: Methodsmentioning

confidence: 99%

Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis

et al. 2022

Self Cite

View full text Add to dashboard Cite

Introduction Intermittent claudication is the leading symptom of peripheral artery disease (leg pain when walking). The present study investigates the extent to which walking impairment is associated with health-related quality of life, mental health and health risk behavior. Methods A theory-based, cross-sectional path model was empirically examined using pre-intervention baseline data from a multicenter, randomized-controlled trial of patients with intermittent claudication (PAD-TeGeCoach). Data were available from 1 696 patients who completed a battery of questionnaires between April 14, 2018 and March 12, 2019, including measures of walking impairment (Walking Impairment Questionnaire), health-related quality of life (SF-12), mental burden (GAD-7, PHQ-9), nicotine- and alcohol-related risk behavior (Fagerström-Test, AUDIT-C). Sociodemographic characteristics and comorbid conditions were included in the postulated model a priori to minimize confounding effects. Results Walking impairment was associated with an increase in depressive (β = -.36, p < .001) and anxiety symptoms (β = -.24, p < .001). The prevalence of depressive and anxiety symptoms was 48.3% and 35.5%, respectively, with female patients and those of younger age being at greater risk. Depressive symptoms were predictive of an increased tobacco use (β = .21; p < .001). Walking impairment had adverse effects on physical quality of life, both directly (β = .60, p < .001) and indirectly mediated through depressive symptoms (β = -.16, p < .001); and indirectly on mental quality of life mediated through depressive (β = -.43, p < .001) and anxiety symptoms (β = -.35, p < .001). Discussion The findings underscore the need for a comprehensive treatment strategy in patients with intermittent claudication. Measures to improve walking impairment (e.g. exercise training) are key to enhance quality of life and should be the primary treatment. As a key mediator of mental quality of life, depressive and anxiety symptoms should be addressed by rigorously including mental health treatment. Risky health behaviors should be approached by promoting behavior change (e.g. smoking cessation) as a secondary prevention of peripheral artery disease.

show abstract

“…Even though SET is easy to practice and highly cost-effective, adherence to regular SET performance is relatively low [ 6 , 7 ]. The underuse of exercise can be partly explained by the lack of institutional resources [ 8 ] and both patients’ and physicians’ lack of interest in exercise [ 4 , 9 ].…”

Section: Introductionmentioning

confidence: 99%

Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial

Paldán¹,

Steinmetz²,

Simanovski³

et al. 2021

JMIR Mhealth Uhealth

View full text Add to dashboard Cite

Background Mobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease. Objective This pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients’ peripheral arterial disease–related quality of life. Methods This was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version. Results The intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (–38.8 meters, SD 53.7; P=.01). The peripheral arterial disease–related quality of life increased significantly in terms of “symptom perception” and “limitations in physical functioning.” Users’ feedback showed increased motivation and a changed attitude toward performing supervised exercise training. Conclusions Besides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future. Trial Registration ClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228

show abstract

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

Cited by 8 publications

References 96 publications

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial

The effect of telephone health coaching and remote exercise monitoring for peripheral artery disease (TeGeCoach) on health care cost and utilization: results of a randomized controlled trial

Effects of walking impairment on mental health burden, health risk behavior and quality of life in patients with intermittent claudication: A cross-sectional path analysis

Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial

Contact Info

Product

Resources

About