MedTrace Logo

Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication

NCT04390282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-18

No results posted yet for this study

Summary

A randomized controlled pilot trial will be used to test Lifepod®PAD as secondary prevention support system. Approximately 60 patients with intermittent claudication at the Department of vascular diseases at Skåne University hospital will be invited. The intervention group (n=30) will test Lifepod PAD for 3 months and the control group (n=30) will receive secondary prevention as usual. Primary outcome is pain free walking distance and secondary outcomes will be quality of life, illness perception, ankle brachial pressure, self-efficacy, adherence to medical treatment and blood pressure. Acceptability, delivery of the intervention, expected sample size and effect size, procedure of randomization and follow-ups will be evaluated. The outcome will be used to design a main randomized trial. Combinations of quantitative measures and qualitative interviews will be used to understand the process in detail.

Conditions

  • Intermittent Claudication
  • Vascular Diseases

Interventions

BEHAVIORAL

Application-based support system

All participants (experimental and control group) will be invited to a separate appointment at the vascular open clinic at baseline and after three months and measured regarding weight, blood pressure, Ankle Brachial Pressure Index, six minutes walking test and pain. To calculate the estimate 10-year risk of manifesting clinical cardiovascular disease, the Framingham Risk Score will be used. Further, a questionnaire will be answered at baseline and after three months containing the instruments, VascuQoL-6, Health Education Impact Questionnaire and Medication Adherence Report Scale-5.

Sponsors & Collaborators

  • Skane University Hospital

    collaborator OTHER

  • Malmö University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-02-22
Completion
2022-02-28

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390282 on ClinicalTrials.gov