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An E-health Intervention for Patients With Peripheral Artery Disease (I-PAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05029739
Recruitment Status : Recruiting
First Posted : September 1, 2021
Last Update Posted : November 9, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Skane University Hospital
Karlstad Central Hospital
Jonkoping County Hospital
Sidekick Health
Information provided by (Responsible Party):
Joakim Nordanstig, Sahlgrenska University Hospital, Sweden

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease Not Applicable

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

  1. 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.
  2. 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.
  3. 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.
  4. Healthcare cost will be reduced at 12 month follow-up in the intervention arm.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter prospective randomized open blinded end-point (PROBE)
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will be blinded for group assignment at the 12 weeks and 12 month follow-up visit.
Primary Purpose: Treatment
Official Title: An Interactive E-health Intervention to Promote Walking Capacity and Life-style Changes in Peripheral Artery Disease (iPAD)
Actual Study Start Date : October 12, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E-intervention group
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.
Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease
See description of the e-intervention group as above.

Active Comparator: Standard of care - control group.
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.
Device: A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease
See description of the e-intervention group as above.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Smoking status [ Time Frame: 12 weeks and 12 months ]
    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

  2. Increased readiness to quit smoking. [ Time Frame: 12 weeks and 12 months ]
    This outcome will be measured through the smoking 'Readiness to quit' questionnaire (The Contemplation Ladder) at baseline, 12 weeks and 12 months.

  3. Medication adherence improvement [ Time Frame: 12 weeks and 12 months ]
    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.

  4. Disease-specific health-related quality of life. [ Time Frame: 12 weeks and 12 months ]
    Health related quality of life; measured by the disease-specific questionnaire VascuQoL-6 at baseline, 12 weeks and 12 months.

  5. Comparing outcomes to health literacy [ Time Frame: 12 weeks and 12 months ]
    Comparing outcomes to health literacy measured through a questionnaire; HLS-EU-Q16 at baseline.

  6. Quality Adjusted Life Years (QALYs) [ Time Frame: 12 months ]
    Calculated based on recorded accumulated costs and registered EQ5D-5L outcomes

  7. Change in self-assessed stress levels [ Time Frame: 12 weeks ]
    Self-reported ordinal scale ranging from 0 to 10

  8. Change in self-assessed sleep quality levels [ Time Frame: 12 weeks ]
    Self-reported ordinal scale ranging from 0 to 10

  9. Change in self-assessed energy levels [ Time Frame: 12 weeks ]
    Self-reported ordinal scale ranging from 0 to 10

  10. Change in free living physical activity [ Time Frame: 12 Weeks ]
    Measured as total step count per day



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05029739


Contacts
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Contact: Joakim Nordanstig, MD,PhD 0046708259496 joakim.nordanstig@vgregion.se
Contact: Vishal Amlani, MD 0046739137374 vishal.amlani@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: Joakim Nordanstig         
Jönköping Central Hospital Recruiting
Jönköping, Sweden
Contact: Manne Andersson         
Karlstad Central Hospital Recruiting
Karlstad, Sweden
Contact: Birgitta Sigvant         
Skane University Hospital Recruiting
Malmö, Sweden
Contact: Anders Gottsäter         
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Carl-Magnus Wahlgren         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Skane University Hospital
Karlstad Central Hospital
Jonkoping County Hospital
Sidekick Health
Investigators
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Principal Investigator: Joakim Nordanstig, MD,PhD Institute of Medicine at the Sahlgrenska Academy, University of Gothenburg, Sweden.
  Study Documents (Full-Text)

Documents provided by Joakim Nordanstig, Sahlgrenska University Hospital, Sweden:
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Responsible Party: Joakim Nordanstig, Associate Professor of Vascular Surgery, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT05029739    
Other Study ID Numbers: I-PAD
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized IPD may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joakim Nordanstig, Sahlgrenska University Hospital, Sweden:
Peripheral Artery Disease
E-intervention
Best medical therapy
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases