Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease

Study Overview
=================
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.

Official Title
-----------------
PAD-TeGeCoach: Health Coaching and Telemetry Supported Walking Exercise for Improving Quality of Life

Conditions
-----------------
Cardiovascular Diseases, Peripheral Artery Disease, Atherosclerosis, Peripheral Arterial Disease, Arterial Occlusive Diseases, Vascular Diseases, Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Behavioral: TeGeCoach


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TeGeCoach<br>Home-based exercise program consisting of telephone health coaching, remote walking exercise monitoring based on wearable monitors and intensified primary care. | Behavioral: TeGeCoach<br>* 12-month long telephone health coaching carried out by specially trained coaches. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques. Primary care physicians will be constantly involved receiving regular health reports from the coach. The walking exercise is based on the principle of interval training. Patients will continuously wear an activity monitor device to review their exercise performance and for remote exercise monitoring by the coach. This activity information will be regularly reviewed by the coach to ensure that the patient adheres to the individual walking exercise prescription.<br>|
| No Intervention: Usual care group (TAU)<br>Patients randomized to TAU receive written information about courses offered by their statutory health insurance. Health insurance companies offer a variety of courses to encourage regular exercise and to promote lifestyle changes, including SEPs (vascular and cardio exercise), physical therapy, nutritional assistance programs, smoking cessation programs, weight loss programs, and patient education programs for obesity and diabetes. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on Walking Impairment Questionnaire (WIQ) | The patient-reported WIQ is a valid clinical tool to classify patient-perceived walking impairment in patients with PAD in terms of pain, walking speed, walking distance and the climbing of stairs. The WIQ has been shown to be responsive to treatment effects and thus can be used as an alternative to treadmill testing for an objective assessment of walking claudication. | baseline, 12-month and 24-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score on Walking Estimated Limitation Calculated by History (WELCH) questionnaire | The WELCH is a four-item questionnaire to estimate walking limitation in patients with suspected peripheral artery disease. | baseline, 12-month and 24-month follow-up | 
| Change in score on EQ5D-5L questionnaire | The EQ5D-5L is a standardized instrument developed by the EuroQoL Group for the measurement of health-related quality of life. There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ5D-5L has been validated for the general German population. | baseline, 12-month and 24-month follow-up | 
| Change in score on Short Form Health Survey (SF-12) | The SF-12 is a self-report questionnaire for the measurement of generic health status involving multiple health dimensions: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. SF-12 is a short version of the SF-36, with good psychometric properties. The German version has been cross-validated with the original English version. | baseline, 12-month and 24-month follow-up | 
| Change in score on Vascular Quality of Life Questionnaire (VascuQoL-25) | The VascuQol-25 is a highly-responsive validated questionnaire for the measurement of PAD-specific health-related quality of life, with a high level of construct and convergence validity. The questionnaire consists of five domains (Activity, Symptom, Pain, Emotional and Social) and has 25 items in total. | baseline, 12-month and 24-month follow-up | 
| Change in score on Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a brief valid questionnaire for the diagnosis of depression that can also be used to identify depression outcome measures and changes over time. The German version has been validated twice. | baseline, 12-month and 24-month follow-up | 
| Change in score on Generalized Anxiety Disorder (GAD-7) questionnaire | The GAD-7 is brief questionnaire for the detection of Generalized Anxiety Disorder, which has been validated in primary care setting and in the general population. | baseline, 12-month and 24-month follow-up | 
| Change in score on Alcohol Use Disorders Identification Test (AUDIT-C) | The AUDIT-C is a brief screening instrument to identify harmful alcohol consumption, consisting of three questions. Regarding its psychometric properties, the AUDIT-C has been shown to be reliable and valid instrument to screen alcohol misuse in primary care settings. | baseline, 12-month and 24-month follow-up | 
| Change in score on Fagerström Test for Nicotine Dependence (FTND) | To identify tobacco dependence, the 6-item long Fagerström Test for Nicotine Dependence (FTND) will be used, which has been shown to be validly assessing the physical addiction to nicotine. | baseline, 12-month and 24-month follow-up | 
| Change in score on Health Literacy Questionnaire (HLQ) | The HLQ is a comprehensive tool with excellent psychometric properties for the measurement of health literacy. The HLQ examines nine dimensions of health literacy. | baseline, 12-month and 24-month follow-up | 
| Change in score on Patient Activation Measure (PAM-13) | PAM-13 has been shown to be a valuable tool for the measurement of patient activation by dividing people into one of four activation levels. The German version has been validated, with good psychometric properties. | baseline, 12-month and 24-month follow-up | 
| Change in utilization of medical services | Routine health insurance data: time period until hospitalization; probability of hospitalization; number and duration of inpatient hospitalization; outpatient medical treatment; drug dose (defined daily dose - DDD). | baseline, 12-month and 24-month follow-up | 
| Change in severe (adverse) events | Routine health insurance data: death, amputation, revascularization, etc. | baseline, 12-month and 24-month follow-up | 
| Change in total health care costs | Routine health insurance data: hospital billing and insurance reimbursement; inpatient hospital cost; inpatient rehabilitation costs; ambulatory care costs; costs for drugs and other medical supplies; sick pay costs. | baseline, 12-month and 24-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, Peripheral Artery Disease, Peripheral Arterial Disease