Intermittent ClaudicationI-PADNCT05029739
An E-health Intervention for Patients With Peripheral Artery Disease
A study testing A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease in people with Intermittent Claudication, run by Sahlgrenska University Hospital at 5 sites in Sweden.
Trial summary
The specific study aim is to determine whether a 12-week digitally delivered behavior change intervention for patients with peripheral artery disease increases walking ability, reduces smoking, improves quality of life and improves medication adherence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 5 sitesSweden
- Study dates
- 12 Oct 2021to Dec 2024
- 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
- Adults with confirmed PAD referred to a vascular surgery unit for evaluation and treatment, currently on best medical treatment and own/have access to a mobile smartphone
- Stable PAD disease and limb symptoms during the last 3 months.
- PAD is the activity-limiting disease
- Abnormal resting ankle-brachial index (ABI) (≤0.90), falsely elevated ABI above 1.3 or a 30% post-exercise ABI reduction.
Who cannot join
- Critical limb ischemia, prior amputation, or other diseases/ impairment that limit the walking ability and the 6-minute walk test's proper conduct
- Cognitive impairment
- Prior revascularization less than one year ago
- A planned revascularization procedure during the upcoming 12 months (known at baseline).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Sahlgrenska University Hospital
Gothenburg
Jönköping Central Hospital
Jönköping
Karlstad Central Hospital
Karlstad
Skane University Hospital
Malmö
Karolinska University Hospital
Stockholm
About this study
Official title: An Interactive E-health Intervention to Promote Walking Capacity and Life-style Changes in Peripheral Artery Disease (iPAD)
The specific study aim is to determine whether a 12-week digitally delivered behavior change intervention for patients with peripheral artery disease increases walking ability, reduces smoking, improves quality of life and improves medication adherence. The primary and secondary endpoints will primarily be captured at a 12 weeks follow-up visit, but a follow-up visit after 12 months is also planned; to assess longer term effect on outcomes and healthcare cost.
Read the detailed description
Peripheral artery disease (PAD) is a highly prevalent atherosclerotic syndrome with an estimated global population burden of ~200 million people. PAD patients are at heightened risk for adverse cardiovascular- and limb events and impaired quality of life. Cigarette smoking is the most important modifiable risk factor. Patients with PAD who smoke have higher disease progression rates, greater risk of complications, poor post-procedural outcomes, compromised functional status, and increased hospitalizations.
A significant goal of PAD treatment includes risk factor modification and prevention of cardiovascular events. Guideline-directed therapy includes cardioprotective pharmacotherapies, and lifestyle modification. Nevertheless, adherence to pharmacologic and lifestyle recommendations in PAD is uncertain. Effective non-pharmacologic therapies for PAD also exist, including smoking cessation, exercise support, and diet counseling. However, limited data is available on mobile applications offering digitally delivered lifestyle change support, including a structured exercise program and smoking cessation support. This study aims to digitally provide lifestyle change support, including a structured and PAD-focused lifestyle program and smoking cessation support via a mobile platform (Sidekick Health) with the primary aim to increase patients' walking ability and secondary aims to reduce smoking and improve medication adherence.
Hypotheses
- At the end of the 12 weeks, the interventional arm will reach a clinically meaningful change in walking ability, as compared to controls, measured by a change in the 6-MWT at twelve-week, and 12 months; the minimal clinically important difference (MCID) is defined as +12m.
- At the end of the 12 weeks, ≥15% interventional treatment arm participants will give up smoking or have significantly reduced their daily smoking compared to less than <10% in the control arm.
- At the end of the 12 weeks, ≥50% of interventional treatment arm participants will improve their medication adherence from pre- until post-intervention as compared to <30% in the control arm.
- Healthcare cost will be reduced at 12 month follow-up in the intervention arm.
- Conditions
- Intermittent Claudication
- Being tested
- A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease
- Keywords
- Peripheral Artery Disease, E-intervention, Best medical therapy
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery DiseaseDevice
See description of the e-intervention group as above.
| Study group | Role | What they receive |
|---|---|---|
| E-intervention group | Experimental | Participants will be instructed to download a life-style-changing mobile app to which they will have access for 12 weeks. After the first week of the program, participants who smoke will be offered to incorporate smoking cessation support into their PAD program. These changes are minor and not intended to divide the intervention group in two but instead to personalize the study experience. The program aims to empower positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm. Receives: Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease |
| Standard of care - control group. | Active comparator | All patients in the control arm will receive best medical therapy including start or optimization of secondary preventive pharmacotherapy, smoking cessation advise and advise on modifiable risk factors. The control arm will also receive an information leaflet about relevant lifestyle modifications for PAD. After the baseline measurements and data collection, there will be no scheduled visits to a health care provider until week 12. Receives: Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test.
Change in objectively measured (pain-free and maximal) walking capacity (as measured with the 6-Minute Walk Distance Test) from baseline to 12 weeks and 12 months
Measured: 12 weeks and 12 months
Secondary outcomes (10)
Smoking status
Change in patients´ daily smoking patterns from pre to post-intervention and at 12-months. This outcome will be measured through a carbon mononoxide exhalor test and by patient-reported daily frequency of cigarettes smoked at baseline, 12 weeks and 12 months
Measured: 12 weeks and 12 months
Increased readiness to quit smoking.
This outcome will be measured through the smoking 'Readiness to quit' questionnaire (The Contemplation Ladder) at baseline, 12 weeks and 12 months.
Measured: 12 weeks and 12 months
Medication adherence improvement
To determine patients' adherence to their medications after the usage of the smartphone application as compared to standard of care. This secondary outcome will be measured through a questionnaire; Morisky Medication Adherence Scale, MMAS-8 at baseline, 12 weeks and 12 months.
Measured: 12 weeks and 12 months
Disease-specific health-related quality of life.
Health related quality of life; measured by the disease-specific questionnaire VascuQoL-6 at baseline, 12 weeks and 12 months.
Measured: 12 weeks and 12 months
Comparing outcomes to health literacy
Comparing outcomes to health literacy measured through a questionnaire; HLS-EU-Q16 at baseline.
Measured: 12 weeks and 12 months
Quality Adjusted Life Years (QALYs)
Calculated based on recorded accumulated costs and registered EQ5D-5L outcomes
Measured: 12 months
Change in self-assessed stress levels
Self-reported ordinal scale ranging from 0 to 10
Measured: 12 weeks
Change in self-assessed sleep quality levels
Self-reported ordinal scale ranging from 0 to 10
Measured: 12 weeks
Change in self-assessed energy levels
Self-reported ordinal scale ranging from 0 to 10
Measured: 12 weeks
Change in free living physical activity
Measured as total step count per day
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start12 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective randomized open blinded end-point (PROBE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital, Karlstad Central Hospital, Jonkoping County Hospital, Sidekick Health
- Responsible party
- Principal investigator, Joakim Nordanstig, Sahlgrenska University Hospital
- Investigators
- Joakim Nordanstig, MD,PhD, Principal investigator, Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029739
- Sponsor's protocol ID
- I-PAD
- Acronym
- I-PAD
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interactive E-health Intervention to Promote Walking Capacity and Life-style Changes in Peripheral Artery Disease (iPAD)
- ClinicalTrials.gov ID
- NCT05029739
- Acronym / sponsor ID
- I-PAD / I-PAD
- Conditions
- Intermittent Claudication
- Keywords
- Peripheral Artery Disease, E-intervention, Best medical therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Skane University Hospital, Karlstad Central Hospital, Jonkoping County Hospital, Sidekick Health
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2021 (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.
The specific study aim is to determine whether a 12-week digitally delivered behavior change intervention for patients with peripheral artery disease increases walking ability, reduces smoking, improves quality of life and improves medication adherence. The primary and secondary endpoints will primarily be captured at a 12 weeks follow-up visit, but a follow-up visit after 12 months is also planned; to assess longer term effect on outcomes and healthcare cost.
Detailed description
Peripheral artery disease (PAD) is a highly prevalent atherosclerotic syndrome with an estimated global population burden of ~200 million people. PAD patients are at heightened risk for adverse cardiovascular- and limb events and impaired quality of life. Cigarette smoking is the most important modifiable risk factor. Patients with PAD who smoke have higher disease progression rates, greater risk of complications, poor post-procedural outcomes, compromised functional status, and increased hospitalizations.
A significant goal of PAD treatment includes risk factor modification and prevention of cardiovascular events. Guideline-directed therapy includes cardioprotective pharmacotherapies, and lifestyle modification. Nevertheless, adherence to pharmacologic and lifestyle recommendations in PAD is uncertain. Effective non-pharmacologic therapies for PAD also exist, including smoking cessation, exercise support, and diet counseling. However, limited data is available on mobile applications offering digitally delivered lifestyle change support, including a structured exercise program and smoking cessation support. This study aims to digitally provide lifestyle change support, including a structured and PAD-focused lifestyle program and smoking cessation support via a mobile platform (Sidekick Health) with the primary aim to increase patients' walking ability and secondary aims to reduce smoking and improve medication adherence.
Hypotheses
- At the end of the 12 weeks, the interventional arm will reach a clinically meaningful change in walking ability, as compared to controls, measured by a change in the 6-MWT at twelve-week, and 12 months; the minimal clinically important difference (MCID) is defined as +12m.
- At the end of the 12 weeks, ≥15% interventional treatment arm participants will give up smoking or have significantly reduced their daily smoking compared to less than <10% in the control arm.
- At the end of the 12 weeks, ≥50% of interventional treatment arm participants will improve their medication adherence from pre- until post-intervention as compared to <30% in the control arm.
- Healthcare cost will be reduced at 12 month follow-up in the intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter prospective randomized open blinded end-point (PROBE)
| Arm | Type | Receives |
|---|---|---|
| E-intervention group | Experimental | Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery DiseaseParticipants will be instructed to download a life-style-changing mobile app to which they will have access for 12 weeks. After the first week of the program, participants who smoke will be offered to incorporate smoking cessation support into their PAD program. These changes are minor and not intended to divide the intervention group in two but instead to personalize the study experience. The program aims to empower positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm. |
| Standard of care - control group. | Active comparator | Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery DiseaseAll patients in the control arm will receive best medical therapy including start or optimization of secondary preventive pharmacotherapy, smoking cessation advise and advise on modifiable risk factors. The control arm will also receive an information leaflet about relevant lifestyle modifications for PAD. After the baseline measurements and data collection, there will be no scheduled visits to a health care provider until week 12. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with confirmed PAD referred to a vascular surgery unit for evaluation and treatment, currently on best medical treatment and own/have access to a mobile smartphone
- Stable PAD disease and limb symptoms during the last 3 months.
- PAD is the activity-limiting disease
- Abnormal resting ankle-brachial index (ABI) (≤0.90), falsely elevated ABI above 1.3 or a 30% post-exercise ABI reduction.
Key exclusion criteria (4 listed)
- Critical limb ischemia, prior amputation, or other diseases/ impairment that limit the walking ability and the 6-minute walk test's proper conduct
- Cognitive impairment
- Prior revascularization less than one year ago
- A planned revascularization procedure during the upcoming 12 months (known at baseline).
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 |
|---|---|---|
| A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery DiseaseSee description of the e-intervention group as above. | Device | E-intervention group, Standard of care - control group. |
Primary outcome
Six-minute walk test.
Time frame: 12 weeks and 12 months
Change in objectively measured (pain-free and maximal) walking capacity (as measured with the 6-Minute Walk Distance Test) from baseline to 12 weeks and 12 months
10 secondary outcomes
Smoking status
Time frame: 12 weeks and 12 months
Increased readiness to quit smoking.
Time frame: 12 weeks and 12 months
Medication adherence improvement
Time frame: 12 weeks and 12 months
Disease-specific health-related quality of life.
Time frame: 12 weeks and 12 months
Comparing outcomes to health literacy
Time frame: 12 weeks and 12 months
Quality Adjusted Life Years (QALYs)
Time frame: 12 months
Change in self-assessed stress levels
Time frame: 12 weeks
Change in self-assessed sleep quality levels
Time frame: 12 weeks
Change in self-assessed energy levels
Time frame: 12 weeks
Change in free living physical activity
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No. Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
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.
Joakim Nordanstig, MD,PhD principal investigator
Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease in people with Intermittent Claudication, run by Sahlgrenska University Hospital at 5 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Six-minute walk test. (time frame: 12 weeks and 12 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 17 Apr 2024.