Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06025526
Other study ID # 23_5 ACTIVE-CaRe Pilot
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2023
Est. completion date May 2024

Study information

Verified date August 2023
Source Ludwig Boltzmann Institute for Digital Health and Prevention
Contact Stefan T Kulnik, PhD MRes
Phone 004357255
Email tino.kulnik@dhp.lbg.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical pilot / feasibility study is to determine the feasibility of conducting a large-scale clinical effectiveness trial of the aktivplan digital intervention in cardiac rehabilitation patients. The main questions this study aims to answer are: - Is it feasible to conduct a large-scale (fully powered) effectiveness trial of the aktivplan digital intervention? - What is the usability, user experience and user acceptance of the aktivplan digital intervention? Patients enrolled in a phase II cardiac rehabilitation programme will be randomly allocated to either the intervention group (aktivplan digital intervention) ot the usual care control group and followed-up for 10 weeks after discharge from cardiac rehabilitation. Patients in the intervention group will be given the aktivplan application (app) on their smartphone. A rehabilitation professional will plan a personalised heart-healthy physical activity plan together with the patient and enter it to the aktivplan app. The patient will be asked to follow their personal physical activity plan for 10 weeks, using the aktivplan app to document completed physical activity sessions. Patients in the control group will receive the usual standard of care without the aktivplan digital intervention. Researchers will analyse information such as the rate of recruitment, participant attrition, data completeness and technical stability of the app to determine the feasibility of conducting a large-scale clinical effectiveness trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Enrollment to a cardiac rehabilitation programme phase II, or a rehabilitation programme phase II due to non-cardiac indication but displaying cardiovascular risk factors - Ownership and use of a smartphone compatible with the aktivplan digital intervention and with internet connection - Agreement to attend the study follow-up visit - Written informed consent to take part in the study Exclusion Criteria: - Existing use of a digital intervention for regular heart-healthy physical activity - Medical contraindications for incremental cycle ergometry test - Medical contraindications for regular heart-healthy physical activity and sports - Medical contraindications for use of a smartphone - Inability to carry out cardiovascular training (e.g., due to significant musculoskeletal restrictions) - Participation in another clinical study within the past 6 months - Addiction or other medical conditions causing reduced decisional capacity - Pregnant women in the third trimester - Pregnant women in the first and second trimester with medical contraindication for physical activity and sports - Breastfeeding women with medical contraindication for physical activity and sports - Indication that patient is unlikely to follow study procedures (limited cooperation)

Study Design


Intervention

Other:
aktivplan
The aktivplan digital intervention consists of a digital planning calendar for regular heart-healthy physical activity Towards the end of rehabilitation phase II, health professionals introduce aktivplan and plan a personalised physical activity plan together with their patients using shared decision-making. The physical activity plan is devised for the time after discharge from cardiac rehabilitation. In the aktivplan smatphone app, the patient can view their personalised physical activity plan, check off completed activities, enter additional unplanned activities, and open short videos with exercise instructions. Additional functions of aktivplan include patient-centered goal-setting, automated messages to the patient (motivational messages and reminders), and the possibility for health professionals to monitor all their patients' adherence to the physical activity plan and to contact individual patients directly via the app.
Usual care
Usual care (standard of care) according to international and national cardiac rehabilitation guidelines.

Locations

Country Name City State
Austria REHA Zentrum Salzburg Salzburg
Austria Reha-Klinik Montafon Schruns Vorarlberg

Sponsors (3)

Lead Sponsor Collaborator
Ludwig Boltzmann Institute for Digital Health and Prevention REHA Zentrum Salzburg, Reha-Klinik Montafon

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rate Number of recruits per week 10 weeks
Primary Drop-out rate Number of drop-outs in at the 10-week follow-up visit 10 weeks
Primary Data completeness Percentage of missing data fields in the study database 10 weeks
Primary Adherence to the aktivplan digital intervention Automated usage logging of the aktivplan mobile application (Matomo platform) 10 weeks
Primary Usability of the aktivplan digital intervention mHealth App Usability Questionnaire (MAUQ) 10 weeks
Primary User experience of the aktivplan digital intervention AttrakDiff Short Questionnaire 10 weeks
Primary User acceptance of the aktivplan digital intervention Mobile Application Rating Scale (MARS) 10 weeks
Primary Technical stability of the aktivplan digital intervention Number and types of technical problems (qualitative data) 10 weeks
Primary Use of alternative and additional strategies for supporting physical activity Number and types of additional strategies (qualitative data) 10 weeks
Primary Experiences and perspectives of patients regarding their study participation Qualitative data from semi-structured interviews 10 weeks
Primary Experiences and perspectives of rehabilitation professionals regarding the intervention and study procedures Qualitative data from focus groups 10 weeks
Secondary Exercise capacity Incremental cycle ergometry test 10 weeks
Secondary Physical activity behaviour Moderate to vigorous physical activity (MVPA) 10 weeks
Secondary Weight Weight in kg 10 weeks
Secondary Blood pressure Blood pressure in mmHg 10 weeks
Secondary Blood cholesterol Total cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol / HDL-cholesterol ratio 10 weeks
Secondary HbA1c HbA1c level 10 weeks
Secondary Smoking Number and type of smoking products per week (qualitative data) 10 weeks
Secondary Health-related quality of life EQ-5D-5L Questionnaire 10 weeks
Secondary Exercise self-efficacy Exercise Self-Efficacy Scale (ESES) 10 weeks
Secondary Patient safety Adverse events reporting (number and severity of adverse events) assessed by the Medical Device Coordination Group (MDCG) form 10 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)