Clinical trial NCT03496948: Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease
Official title: PAD-TeGeCoach: Health Coaching and Telemetry Supported Walking Exercise for Improving Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Atherosclerosis
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Peripheral Vascular Diseases
Cardiovascular Diseases
Keywords: PAD
Peripheral Artery Disease
Peripheral Arterial Disease
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 1982
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)
Primary purpose: TREATMENT

Brief summary: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of the this study is to explore the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program, compared to usual care. TeGeCoach consists of telephone health coaching, remote walking exercise monitoring based on wearable activity monitors and intensified primary care. It is hypothesized that TeGeCoach will improve functional outcomes and will reduce total health care costs.

Detailed description: Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pressure and sedentary lifestyle. The most prominent symptom is leg pain while walking known as intermittent claudication, as the muscles do not get enough blood during exercise to meet the needs. To improve mobility, first line treatment for intermittent claudication are outpatient supervised exercise programs (SEPs); however, their implementation face manifold challenges: low patient adherence, no reimbursement by insurers, high costs of course implementation, and low course availability. These barriers led to the development of home-based exercise programs, which are similarly effective when combined with a structured approach by setting exercise goals, monitoring exercise activity, and regular follow up with a coach. Therefore, this trial aims to determine the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long structured home-based exercise program (HEP), compared with usual care of intermittent claudication. It is hypothesized that TeGeCoach will improve walking impairment and will lower the need of health care resources that are spent on patients with PAD at 24-month follow-up.

The investigators will conduct a prospective, open-label, pragmatic randomized controlled clinical trial in a health insurance setting. 1760 patients with peripheral artery disease at Fontaine stage II will be randomly assigned either to TeGeCoach or Care-as-usual (usual care). TeGeCoach consists of telemonitored walking exercise using wearable activity trackers, telephone health coaching and medical supervision by a physician. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques for supporting better patient engagement and activation, disease self-care, treatment adherence and lifestyle management. Depending on the individual functional status and exercise capacity, participants will be asked to walk up to seven times a week. Usual care participants regularly receive information leaflets and can access supervised exercise programs, physical therapy and a variety of programs for promoting a healthy lifestyle. Primary outcomes are functional capacity measured by the Walking Impairment Questionnaire (WIQ). Secondary outcome measures include quality of life, health literacy and health behavior. Claims data is used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes will be measured at three time points (0, 12, and 24 months).

Clearly, the current routine care of intermittent claudication in patients with PAD is partly ineffective und insufficient, with the consequence of a poorly served patient population and worsening disease condition. TeGeCoach may provide an effective and feasible alternative in the management of intermittent claudication by improving access to supervised exercise while at the same time potentially reducing health care costs.

Eligibility criteria: Inclusion Criteria:

* Insured with one of the three participating health insurance companies
* Sufficient German language skills to follow the telephone-based health coaching
* Access to a telephone (landline or mobile);
* Primary or secondary diagnosis of PAD at Fontaine stage IIa or IIb within the last 36 months, but no primary or secondary diagnosis of PAD at Fontaine stage I within the last 12 months; or at Fontaine stage III or IV within the last 36 months

Inpatient and outpatient diagnoses from routine statutory health insurance data will be used to identify eligible patients.

Exclusion Criteria:

* Immobility that goes beyond claudication (inability to carry out intervention and competing risks)
* Severe and persistent mental disorders (adherence reasons)
* Suicidality (safety reasons)
* Life-threatening somatic diseases (e.g., cancer; competing risk)
* Active or recent participation in any other PAD intervention trial
* Ongoing hospitalization; alcoholism and other drug dependency (adherence reasons)
* Heart failure graded New York Heart Association (NYHA) class III and IV (inability to carry out intervention and competing risks)

Ineligible patients are identified based on diagnoses that were made in inpatient settings only, given the considerable number of diagnostic errors in outpatient settings.

Primary outcomes:
measure: Change in score on Walking Impairment Questionnaire (WIQ)
timeFrame: baseline, 12-month and 24-month follow-up
Secondary outcomes:
measure: Change in score on Walking Estimated Limitation Calculated by History (WELCH) questionnaire
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on EQ5D-5L questionnaire
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Short Form Health Survey (SF-12)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Vascular Quality of Life Questionnaire (VascuQoL-25)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Generalized Anxiety Disorder (GAD-7) questionnaire
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Fagerström Test for Nicotine Dependence (FTND)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Health Literacy Questionnaire (HLQ)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in score on Patient Activation Measure (PAM-13)
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in utilization of medical services
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in severe (adverse) events
timeFrame: baseline, 12-month and 24-month follow-up
measure: Change in total health care costs
timeFrame: baseline, 12-month and 24-month follow-up
Other outcomes:
measure: Questionnaire on Satisfaction in Outpatient Care (ZAPA; intervention arm only)
timeFrame: 12-month follow-up
measure: Change in exercise adherence (intervention arm only)
timeFrame: baseline and 12-month follow-up
measure: Change in amount of steps/net walking time (intervention arm only)
timeFrame: baseline and 12-month follow-up
Locations:
city: Hamburg
country: Germany
facility: TK statutory health insurance
city: Hannover
country: Germany
facility: KKH statutory health insurance
city: Nürnberg
country: Germany
facility: Mhplus Statutory Health Insurance
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jörg Dirmaier, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: KKH statutory health insurance
name: Frank Bienert
role: STUDY_DIRECTOR
affiliation: KKH statutory health insurance
name: Lutz Herbarth, Dr.
role: STUDY_CHAIR
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