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

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.

Needs and Requirements in the Designing of Mobile Interventions for Patients With Peripheral Arterial Disease: Questionnaire Study.

BACKGROUND: The development of mobile interventions for noncommunicable diseases has increased in recent years. However, there is a dearth of apps for patients with peripheral arterial disease (PAD), who frequently have an impaired ability to walk. OBJECTIVE: Using a patient-centered approach for the development of mobile interventions, we aim to describe the needs and requirements of patients with PAD regarding the overall care situation and the use of mobile interventions to perform supervised exercise therapy (SET). METHODS: A questionnaire survey was conducted in addition to a clinical examination at the vascular outpatient clinic of the West-German Heart and Vascular Center of the University Clinic Essen in Germany. Patients with diagnosed PAD were asked to answer questions on sociodemographic characteristics, PAD-related need for support, satisfaction with their health care situation, smartphone and app use, and requirements for the design of mobile interventions to support SET. RESULTS: Overall, a need for better support of patients with diagnosed PAD was identified. In total, 59.2% (n=180) expressed their desire for more support for their disease. Patients (n=304) had a mean age of 67 years and half of them (n=157, 51.6%) were smartphone users. We noted an interest in smartphone-supported SET, even for people who did not currently use a smartphone. "Information," "feedback," "choosing goals," and "interaction with physicians and therapists" were rated the most relevant components of a potential app. CONCLUSIONS: A need for the support of patients with PAD was determined. This was particularly evident with regard to disease literacy and the performance of SET. Based on a detailed description of patient characteristics, proposals for the design of mobile interventions adapted to the needs and requirements of patients can be derived.

Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial.

BACKGROUND: Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, the ongoing decrease of the pain-free walking distance occurs with a significant reduction in patients' quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health technologies is mainly targeted at patients with cardiovascular disease in general. The special requirement of patients with PAD is the need to reach a certain pain level to improve the pain-free walking distance. Unfortunately, both poor adherence and availability of institutional resources are major problems in patient-centered care. OBJECTIVE: The objective of this trackPAD pilot study is to evaluate the feasibility of a mobile phone-based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. We also aim for a subsequent patient centered adjustment of the app prototype based on the results of the app evaluation and process evaluation. METHODS: This study was designed as a closed user group trial, with assessors blinded, and parallel group study with face-to-face components for assessment with a follow-up of 3 months. Patients with symptomatic PAD (Fontaine stage IIa or IIb) and possession of a mobile phone were eligible. Eligible participants were randomly assigned into study and control group, stratified by their distance covered in the 6-min walk test, using the software TENALEA. Participants randomized to the study 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 only usual care. TrackPAD records the frequency and duration of training sessions and pain level using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (6-min walk test, ankle-brachial index, and duplex ultrasound at the lower arteries) and self-reported quality of life. Usability and quality of the app was determined using the user version of the Mobile Application Rating Scale. RESULTS: The study enrolled 45 participants with symptomatic PAD (44% male). Of these participants, 21 (47%) were randomized to the study group and 24 (53%) were randomized to the control group. The distance walked in the 6-min walk test was comparable in both groups at baseline (study group: mean 368.1m [SD 77.6] vs control group: mean 394.6m [SD 100.6]). CONCLUSIONS: This is the first trial to test a mobile intervention called trackPAD that was designed especially for patients with PAD. Its results will provide important insights in terms of feasibility, effectiveness, and patient preferences of an app-based mobile intervention supporting SET for the conservative treatment of PAD. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13651.