An E-health Intervention for Patients With Peripheral Artery Disease

NCT05029739 | Active Not Recruiting

• 1 other identifier: I-PAD
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 5

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.

Conditions

Intermittent Claudication

Keywords

Peripheral Artery Disease; E-intervention; Best medical therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Smoking status

  12 weeks and 12 months

• Increased readiness to quit smoking.

  12 weeks and 12 months

• Medication adherence improvement

  12 weeks and 12 months

• Disease-specific health-related quality of life.

  12 weeks and 12 months

• Comparing outcomes to health literacy

  12 weeks and 12 months

Study Arms (2)

E-intervention group

EXPERIMENTAL

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

Standard of care - control group.

ACTIVE COMPARATOR

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

Interventions

A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease DEVICE

See description of the e-intervention group as above.

E-intervention group; Standard of care - control group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Karolinska University Hospital: collaborator
• Skane University Hospital: collaborator
• Karlstad Central Hospital: collaborator
• Jonkoping County Hospital: collaborator
• Sidekick Health: collaborator

Study Sites (5)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Jönköping Central Hospital

Jönköping, Sweden

Location

Karlstad Central Hospital

Karlstad, Sweden

Location

Skane University Hospital

Malmo, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Joakim Nordanstig, MD,PhD

  Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded for group assignment at the 12 weeks and 12 month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Model Details: Multicenter prospective randomized open blinded end-point (PROBE)

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 1, 2021
• Study Start: October 12, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)