Clinical trial NCT05029739: An E-health Intervention for Patients With Peripheral Artery Disease
Official title: An Interactive E-health Intervention to Promote Walking Capacity and Life-style Changes in Peripheral Artery Disease (iPAD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intermittent Claudication
Keywords: Peripheral Artery Disease
E-intervention
Best medical therapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Skane University Hospital
name: Karlstad Central Hospital
name: Jonkoping County Hospital
name: Sidekick Health
First posted: 2021-09-01
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter prospective randomized open blinded end-point (PROBE)
Primary purpose: TREATMENT

Brief summary: The specific study aim is to determine whether a 12-week digitally delivered behavior change intervention for patients with peripheral artery disease increases walking ability, reduces smoking, improves quality of life and improves medication adherence. The primary and secondary endpoints will primarily be captured at a 12 weeks follow-up visit, but a follow-up visit after 12 months is also planned; to assess longer term effect on outcomes and healthcare cost.

Detailed description: Peripheral artery disease (PAD) is a highly prevalent atherosclerotic syndrome with an estimated global population burden of \~200 million people. PAD patients are at heightened risk for adverse cardiovascular- and limb events and impaired quality of life. Cigarette smoking is the most important modifiable risk factor. Patients with PAD who smoke have higher disease progression rates, greater risk of complications, poor post-procedural outcomes, compromised functional status, and increased hospitalizations.

A significant goal of PAD treatment includes risk factor modification and prevention of cardiovascular events. Guideline-directed therapy includes cardioprotective pharmacotherapies, and lifestyle modification. Nevertheless, adherence to pharmacologic and lifestyle recommendations in PAD is uncertain. Effective non-pharmacologic therapies for PAD also exist, including smoking cessation, exercise support, and diet counseling. However, limited data is available on mobile applications offering digitally delivered lifestyle change support, including a structured exercise program and smoking cessation support. This study aims to digitally provide lifestyle change support, including a structured and PAD-focused lifestyle program and smoking cessation support via a mobile platform (Sidekick Health) with the primary aim to increase patients' walking ability and secondary aims to reduce smoking and improve medication adherence.

Hypotheses

1. At the end of the 12 weeks, the interventional arm will reach a clinically meaningful change in walking ability, as compared to controls, measured by a change in the 6-MWT at twelve-week, and 12 months; the minimal clinically important difference (MCID) is defined as +12m.
2. At the end of the 12 weeks, ≥15% interventional treatment arm participants will give up smoking or have significantly reduced their daily smoking compared to less than \<10% in the control arm.
3. At the end of the 12 weeks, ≥50% of interventional treatment arm participants will improve their medication adherence from pre- until post-intervention as compared to \<30% in the control arm.
4. Healthcare cost will be reduced at 12 month follow-up in the intervention arm.

Eligibility criteria: Inclusion Criteria:

* Adults with confirmed PAD referred to a vascular surgery unit for evaluation and treatment, currently on best medical treatment and own/have access to a mobile smartphone
* Stable PAD disease and limb symptoms during the last 3 months.
* PAD is the activity-limiting disease
* Abnormal resting ankle-brachial index (ABI) (≤0.90), falsely elevated ABI above 1.3 or a 30% post-exercise ABI reduction.

Exclusion Criteria:

* Critical limb ischemia, prior amputation, or other diseases/ impairment that limit the walking ability and the 6-minute walk test's proper conduct
* Cognitive impairment
* Prior revascularization less than one year ago
* A planned revascularization procedure during the upcoming 12 months (known at baseline).

Primary outcomes:
measure: Six-minute walk test.
timeFrame: 12 weeks and 12 months
Secondary outcomes:
measure: Smoking status
timeFrame: 12 weeks and 12 months
measure: Increased readiness to quit smoking.
timeFrame: 12 weeks and 12 months
measure: Medication adherence improvement
timeFrame: 12 weeks and 12 months
measure: Disease-specific health-related quality of life.
timeFrame: 12 weeks and 12 months
measure: Comparing outcomes to health literacy
timeFrame: 12 weeks and 12 months
measure: Quality Adjusted Life Years (QALYs)
timeFrame: 12 months
measure: Change in self-assessed stress levels
timeFrame: 12 weeks
measure: Change in self-assessed sleep quality levels
timeFrame: 12 weeks
measure: Change in self-assessed energy levels
timeFrame: 12 weeks
measure: Change in free living physical activity
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Jönköping
country: Sweden
facility: Jönköping Central Hospital
city: Karlstad
country: Sweden
facility: Karlstad Central Hospital
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.
name: Joakim Nordanstig, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: