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NCT04390282: PRESIC

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

Completed NA Last updated 18 April 2023
What this trial tests

NA trial testing Application-based support system in Intermittent Claudication in 30 participants. Completed in 28 February 2022.

Timeline
1 September 2021
Primary endpoint
22 February 2022
28 February 2022

Quick facts

Lead sponsorMalmö University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment30
Start date1 September 2021
Primary completion22 February 2022
Estimated completion28 February 2022
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Malmö University

Who can join

18 and older, any sex, with Intermittent Claudication or Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Intermittent Claudication

Currently open trials in the same condition.

Other Malmö University trials

Trials by the same sponsor.

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Data sources for this page

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