An E-health Intervention for Patients With Peripheral Artery Disease (I-PAD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intermittent Claudication
• Intervention / Treatment: Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease

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.

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Jönköping, Sweden
    • Jönköping Central Hospital
  • Karlstad, Sweden
    • Karlstad Central Hospital
  • Malmö, Sweden
    • Skåne University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E-intervention group; Participants will be instructed to download a life-style-changing mobile app to which they will have access for 12 weeks. After the first week of the program, participants who smoke will be offered to incorporate smoking cessation support into their PAD program. These changes are minor and not intended to divide the intervention group in two but instead to personalize the study experience. The program aims to empower positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm.	Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease; See description of the e-intervention group as above.
Active Comparator: Standard of care - control group.; All patients in the control arm will receive best medical therapy including start or optimization of secondary preventive pharmacotherapy, smoking cessation advise and advise on modifiable risk factors. The control arm will also receive an information leaflet about relevant lifestyle modifications for PAD. After the baseline measurements and data collection, there will be no scheduled visits to a health care provider until week 12.	Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease; See description of the e-intervention group as above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Comparing outcomes to health literacy	Comparing outcomes to health literacy measured through a questionnaire; HLS-EU-Q16 at baseline.	12 weeks and 12 months
Quality Adjusted Life Years (QALYs)	Calculated based on recorded accumulated costs and registered EQ5D-5L outcomes	12 months
Change in self-assessed stress levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Change in self-assessed sleep quality levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Change in self-assessed energy levels	Self-reported ordinal scale ranging from 0 to 10	12 weeks
Change in free living physical activity	Measured as total step count per day	12 Weeks

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: Karolinska University Hospital; Skane University Hospital; Karlstad Central Hospital; Jonkoping County Hospital; Sidekick Health
• Investigators: Principal Investigator: Joakim Nordanstig, MD,PhD, Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; E-intervention; Best medical therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: I-PAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No