Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback.

Phase 2

Completed

• Conditions: Hypertension; Coronary Disease; Cardiac Diseases
• Interventions: Device: Pedometer; Behavioral: Patient-targeted individual physical-activity-feedback

• Registration Number: NCT02802254
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The aim of this study is to evaluate the efficiency of a minimal intervention on risk perception of physical inactivity in patients with known coronary heart disease (CHD) and patients at risk for CHD. Therefore half of the patients (intervention group) get a personal feedback on their individual level of physical activity measured by pedometers and self-report questionnaires plus information about the risk factor 'physical inactivity' for heart diseases. Following the hypotheses the feedback should increase the patients risk perception of physical inactivity and furthermore increase physical activity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-12
• Study First Submitted QC: 2016-06-12
• Study First Posted: 2016-06-16
• Study Start: 2016-08
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Known coronary heart disease or at least 2 risk factors for coronary heart disease
• Age: 18 years up to 75 years
• Sufficient language skills
• Access to a telephone
• Willingness to participate in telephone interviews
• "Informed consent"

Exclusion Criteria

• Life threatening health status
• Severe somatic or/and psychological disorder that needs urgent treatment
• Hospital stay within the last 7 days
• Surgical intervention plus hospital stay for at least 3 days within the last 2 months
• Myocardial infarction within the last 3 month
• Musculoskeletal diseases, which have a strong influence on physical activity
• Severe cognitive or/and visual difficulties

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pedometer-only	Pedometer	Patients use a Pedometer in order to measure their daily step number
Pedometer+physical-activity-feedback	Patient-targeted individual physical-activity-feedback	At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.
Pedometer+physical-activity-feedback	Pedometer	At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.

Primary Outcome Measures

Name	Time	Method
Risk perception of physical activity level	Outcome measure is assessed at one month follow-up	time of measurement: one month after cardiac consultation

Secondary Outcome Measures

Name	Time	Method
Risk perception of physical activity level	Outcome measure is assessed at three months follow-up	time of measurement: three months after cardiac consultation
Physical activity Level (Pedometer, time spent sitting, IPAQ)	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Somatic symptom severity (PHQ-15)	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Adherence to the pedometer	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Satisfaction and acceptance of the feedback	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Depression severity (PHQ-9)	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Anxiety severity (GAD-7)	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Quality of life (EQ-5D)	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
New York Heart Association Class	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation
Canadian Cardiology Society Class	Outcome measure is assessed at one month follow-up and three months follow-up	time of measurement: one months and three months after cardiac consultation

Trial Locations

Locations (2)

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany

University Heart Center, Medical Center Hamburg Eppendorf; 🇩🇪 Hamburg, Germany