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

Hypertension Clinical Trial

— RiskAct  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02802254
• Other study ID #: 1525/100
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Diseases
• Coronary Disease
• Heart Diseases
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Germany	Cardiologicum Hamburg	Hamburg
Germany	University Heart Center, Medical Center Hamburg Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk perception of physical activity level	time of measurement: one month after cardiac consultation	Outcome measure is assessed at one month follow-up
Secondary	Risk perception of physical activity level	time of measurement: three months after cardiac consultation	Outcome measure is assessed at three months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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