An E-health Intervention for Patients With Peripheral Artery Disease

Intermittent Claudication Clinical Trial

— I-PAD  

Official title:

An Interactive E-health Intervention to Promote Walking Capacity and Life-style Changes in Peripheral Artery Disease (iPAD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05029739
• Other study ID #: I-PAD
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 155
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease

Intervention

Device:
• A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease
See description of the e-intervention group as above.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Jönköping Central Hospital	Jönköping
Sweden	Karlstad Central Hospital	Karlstad
Sweden	Skane University Hospital	Malmö
Sweden	Karolinska University Hospital	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Jonkoping County Hospital, Karlstad Central Hospital, Karolinska University Hospital, Sidekick Health, Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test.	Change in objectively measured (pain-free and maximal) walking capacity (as measured with the 6-Minute Walk Distance Test) from baseline to 12 weeks and 12 months	12 weeks and 12 months
Secondary	Smoking status	Change in patients´ daily smoking patterns from pre to post-intervention and at 12-months. This outcome will be measured through a carbon mononoxide exhalor test and by patient-reported daily frequency of cigarettes smoked at baseline, 12 weeks and 12 months	12 weeks and 12 months
Secondary	Increased readiness to quit smoking.	This outcome will be measured through the smoking 'Readiness to quit' questionnaire (The Contemplation Ladder) at baseline, 12 weeks and 12 months.	12 weeks and 12 months
Secondary	Medication adherence improvement	To determine patients' adherence to their medications after the usage of the smartphone application as compared to standard of care. This secondary outcome will be measured through a questionnaire; Morisky Medication Adherence Scale, MMAS-8 at baseline, 12 weeks and 12 months.	12 weeks and 12 months
Secondary	Disease-specific health-related quality of life.	Health related quality of life; measured by the disease-specific questionnaire VascuQoL-6 at baseline, 12 weeks and 12 months.	12 weeks and 12 months
Secondary	Comparing outcomes to health literacy	Comparing outcomes to health literacy measured through a questionnaire; HLS-EU-Q16 at baseline.	12 weeks and 12 months
Secondary	Quality Adjusted Life Years (QALYs)	Calculated based on recorded accumulated costs and registered EQ5D-5L outcomes	12 months
Secondary	Change in self-assessed stress levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Secondary	Change in self-assessed sleep quality levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Secondary	Change in self-assessed energy levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Secondary	Change in free living physical activity	Measured as total step count per day	12 Weeks