Intermittent ClaudicationPRESICNCT04390282
Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication
A study testing Application-based support system in people with Intermittent Claudication and Vascular Diseases, run by Malmö University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication, Vascular Diseases
- What is being tested?
- Application-based support system
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with intermittent claudication who are considered for revascularization.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Intermittent Claudication, Vascular Diseases
- Being tested
- Application-based support system
- Keywords
- Secondary prevention, Life Style, Healthy, Internet-Based intervention, Illness percetion, Health literacy
- Medical subject headings
- Intermittent Claudication, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application-based support systemBehavioural
Also called Life style support according usual clinical practice
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.
| Study group | Role | What they receive |
|---|---|---|
| Application-based support system Lifepod®PAD | Experimental | 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. Receives: Behavioral: Application-based support system |
| Life style advice according to usual practice | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain free walking distance
Pain free walking distance will be measured by 6 minutes walking test.
Measured: Change from baseline in pain free walking distance baseline at three months
Secondary outcomes (5)
Quality of life assessment
Measured by the quality of life questionnaire Vascuqol 6
Measured: 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
Measured: Change from baseline in ankle brachial pressure index at three months
Illness perception
Measured by Illness Perception Questionnaire
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Sep 2021
- Primary completion22 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Principal investigator, Christine Kumlien, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390282
- Sponsor's protocol ID
- CKtrial2020
- Acronym
- PRESIC
- Status last verified
- Apr 2023
- First submitted
- 5 May 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention and Application-based Lifestyle Support for Patients With Intermittent Claudication
- ClinicalTrials.gov ID
- NCT04390282
- Acronym / sponsor ID
- PRESIC / CKtrial2020
- Conditions
- Intermittent Claudication, Vascular Diseases
- Keywords
- Secondary prevention, Life Style, Healthy, Internet-Based intervention, Illness percetion, Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application-based support system Lifepod®PAD | Experimental | Behavioral: Application-based support systemPatients 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. |
| Life style advice according to usual practice | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with intermittent claudication who are considered for revascularization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application-based support systemAlso: Life style support according usual clinical practiceAll 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. | Behavioural | Application-based support system Lifepod®PAD |
Primary outcome
Pain free walking distance
Time frame: Change from baseline in pain free walking distance baseline at three months
Pain free walking distance will be measured by 6 minutes walking test.
5 secondary outcomes
Quality of life assessment
Time frame: 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
Time frame: Change from baseline in ankle brachial pressure index at three months
Illness perception
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Intermittent Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application-based support system in people with Intermittent Claudication and Vascular Diseases, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain free walking distance (time frame: Change from baseline in pain free walking distance baseline at three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.