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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Hypertension; Cardiac Diseases
• Intervention / Treatment: Behavioral: Patient-targeted individual physical-activity-feedback; Device: Pedometer

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22041
    • Cardiologicum Hamburg
  • Hamburg, Germany, 20246
    • University Heart Center, Medical Center Hamburg Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Study Director: Bernd Löwe, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: June 12, 2016
• First Submitted That Met QC Criteria: June 12, 2016
• First Posted (ESTIMATE): June 16, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; pedometer; risk perception; patient feedback
• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Heart Diseases; Coronary Disease
• Other Study ID Numbers: 1525/100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO