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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT02802254

Collaborator

(none)

121

Enrollment

Locations

Arms

Actual Duration (Months)

60.5

Patients Per Site

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Coronary Disease Cardiac Diseases	Behavioral: Patient-targeted individual physical-activity-feedback Device: Pedometer	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Pedometer+physical-activity-feedback

At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.

Behavioral: Patient-targeted individual physical-activity-feedback

At cardiac consultation receive an individual feedback on their personal physical activity level.

Device: Pedometer

Patients receive a pedometer two weeks prior to cardiac consultation.

Active Comparator: Pedometer-only

Patients use a Pedometer in order to measure their daily step number

Device: Pedometer

Patients receive a pedometer two weeks prior to cardiac consultation.

Outcome Measures

Primary Outcome Measures

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

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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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