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

Study Overview
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Brief Summary
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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.

Official Title
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Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback: Randomized Controlled Trial.

Conditions
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Hypertension, Coronary Disease, Cardiac Diseases

Intervention / Treatment
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* Behavioral: Patient-targeted individual physical-activity-feedback
* Device: Pedometer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer+physical-activity-feedback<br>At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback. | Behavioral: Patient-targeted individual physical-activity-feedback<br>* At cardiac consultation receive an individual feedback on their personal physical activity level.<br>Device: Pedometer<br>* Patients receive a pedometer two weeks prior to cardiac consultation.<br>|
| Active Comparator: Pedometer-only<br>Patients use a Pedometer in order to measure their daily step number | Device: Pedometer<br>* Patients receive a pedometer two weeks prior to cardiac consultation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk perception of physical activity level | time of measurement: one month after cardiac consultation | Outcome measure is assessed at one month follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, patient feedback, risk perception, pedometer