Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease
Condition: Peripheral Artery Disease; Atherosclerosis; Peripheral Arterial Disease; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
Study type: Interventional

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.
    

Intervention name(s): TeGeCoach
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study arms: TeGeCoach (Intervention); Treatment-as-Usual (TAU)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PAD; Peripheral Artery Disease; Peripheral Arterial Disease