Clinical trial NCT02802254: Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback.
Official title: Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypertension
Coronary Disease
Cardiac Diseases
Keywords: physical activity
patient feedback
risk perception
pedometer
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Risk perception of physical activity level
timeFrame: Outcome measure is assessed at one month follow-up
Secondary outcomes:
measure: Risk perception of physical activity level
timeFrame: Outcome measure is assessed at three months follow-up
measure: Physical activity Level (Pedometer, time spent sitting, IPAQ)
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Adherence to the pedometer
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Satisfaction and acceptance of the feedback
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Depression severity (PHQ-9)
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Anxiety severity (GAD-7)
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Somatic symptom severity (PHQ-15)
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Quality of life (EQ-5D)
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: New York Heart Association Class
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
measure: Canadian Cardiology Society Class
timeFrame: Outcome measure is assessed at one month follow-up and three months follow-up
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart Center, Medical Center Hamburg Eppendorf
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Bernd Löwe, Prof. Dr.
role: STUDY_DIRECTOR
References: