Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04390282 |
| Other study ID # |
CKtrial2020 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
February 28, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Malmö University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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)
