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

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Intermittent Claudication
• Intervention / Treatment: Behavioral: Application-based support system

Detailed Description

A randomized controlled pilot trial will be used to test the application-based support systems Lifepod®PAD that are developed in collaboration with Cross Technology Solutions based on results from our systematic review and previous research testing the Lifepod® system in patients with myocardial infarction.

Sample Approximately 60 patients with intermittent claudication diagnosed at the Department of vascular diseases at Skåne University hospital will be invited to participate. The participants should have access to a smartphone or tablet. For the randomization, envelopes will be prepared by a member of the research group and then mixed by another member of the group. After receiving informed consent, the participants are randomized by drawing one of the sealed envelopes with the information in which group they are included. The trial will have two arms; one group will test Lifepod®PAD (n=30) for three months and one control group (n=30) will receive secondary prevention as usual.

Data collection All participants will be invited to a separate appointment at the vascular open clinic at baseline and after three months and measured regarding weight, blood pressure, ABPI, 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 (hei-Q) and Medication Adherence Report Scale-5.

Patients randomized to Lifepod®PAD will get access and be introduced to the Lifepod®PAD support system software. Patients in the control group will receive usual care meaning advice about lifestyle changes and medication from the physician at the visit in the vascular open clinic.

After completing the intervention, a random number of patients who have tested Lifepod®PAD will be invited to take part in focus group interviews to discuss their experiences of using the devices. The interviews will be analyzed by thematic content analysis.

The intervention Lifepod®PAD is a web-based application designed to support adherence to lifestyle advice and medication and is built as a two-side system. One side is the patient interface, the web-based application, accessible through a smartphone or tablet. The patients can log information about their lifestyle, symptoms and medication and review their data in relation to recommended targets. They get positive feedback, recommendations about healthy behaviours and receive notifications as short messages depending on their individual health status. The other side is the medical interface managed by the health care professionals. All information the patient is reporting into the app can be accessed by the treating nurse and the system ranks the patients, thus gives high priority to patients who have the greatest needs.

Analysis Primary outcome will be pain free walking distance according to six minutes walking test at baseline and after three months. Secondary outcomes are quality of life, illness perception, self-efficacy, adherence to medical treatment, blood pressure and ABPI. Acceptability, delivery of the intervention, expected sample size and effect size, procedure of randomization and follow-ups will be further evaluated.

Descriptive statistics will be used to describe the study sample. T-tests will be used to compare groups and chi-square tests will be used to study differences in proportions. Effect size will be calculated to estimate the magnitude of the potential effects and constitute a base for power calculation and sample size in a full-size RCT. The outcome will be used to design a main multicenter randomized trial Ethical considerations Verbal and written information about the purpose of the studies will be given and a written informed consent will be obtained in all studies. Additionally, they will be informed that participating is voluntary and the can withdraw at any time without providing any reason. Approval for the project are provided by the Swedish Regional Ethical Review Board (Dnr 2017/609)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20506
    • Christine Kumlien

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with intermittent claudication diagnosed at the Department of vascular diseases at Skåne University hospital.

The participants should have access to a smartphone or tablet and be able to speak and understand Swedish.

Exclusion Criteria:

• Patients with intermittent claudication who are considered for revascularization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application-based support system Lifepod®PAD; Patients in the experimental group will be introduced to and use Lifepod®PAD, a web-based application designed to support adherence to lifestyle advice and medication for three months. Lifepod®PAD is built as a two-side system. One side is the patient interface, the web-based application, accessible through a smartphone or tablet. The patients can log information about their lifestyle, symptoms and medication and review their data in relation to recommended targets. They get positive feedback, recommendations about healthy behaviours and receive notifications as short messages depending on their individual health status. The other side is the medical interface managed by the health care professionals. All information the patient is reporting into the app can be accessed by the treating nurse and the system ranks the patients, thus gives high priority to patients who have the greatest needs.	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.; Other Names: Life style support according usual clinical practice
No Intervention: Life style advice according to usual practice; Patients in the control group will receive usual care meaning advice about lifestyle changes and medication from the physician at the visit in the vascular open clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain free walking distance	Pain free walking distance will be measured by 6 minutes walking test.	Change from baseline in pain free walking distance baseline at three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Measured by the quality of life questionnaire Vascuqol 6	Change from baseline in Vascuqol 6 total score (min 6 max 24, higher total score means better quality of life) at three months
Ankle brachial pressure index	Index based on calculation of ankle pressure and systolic blood pressure	Change from baseline in ankle brachial pressure index at three months
Illness perception	Measured by Illness Perception Questionnaire	Change from baseline in Illness Perception scale (Include three sections that each have a totalscore, a high totalscore means a personal understanding of illness) at three months
Medication adherence	Measured by Medication Adherence Report Scale	Change from baseline in Medication Adherence Report Scale (min 5 max 25 in total score a higher total score indicates higher level of adherence) at three months
Self efficacy	Measured by General Self-Efficacy Scale	Change from baseline in General Self- Efficacy Scale (min 10 max 40 in total score a higher total score indicates more self efficacy) at three months

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Skane University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Secondary prevention; Health literacy; Life Style, Healthy; Internet-Based intervention; Illness percetion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: CKtrial2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No