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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02802254
Acronym
RiskAct
Enrollment
121
Registered
2016-06-16
Start date
2016-08-31
Completion date
2017-06-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Diseases, Coronary Disease, Hypertension

Keywords

physical activity, patient feedback, risk perception, pedometer

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.

Interventions

BEHAVIORALPatient-targeted individual physical-activity-feedback

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

DEVICEPedometer

Patients receive a pedometer two weeks prior to cardiac consultation.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Risk perception of physical activity levelOutcome measure is assessed at one month follow-uptime of measurement: one month after cardiac consultation

Secondary

MeasureTime frameDescription
Physical activity Level (Pedometer, time spent sitting, IPAQ)Outcome measure is assessed at one month follow-up and three months follow-uptime of measurement: one months and three months after cardiac consultation
Adherence to the pedometerOutcome measure is assessed at one month follow-up and three months follow-uptime of measurement: one months and three months after cardiac consultation
Satisfaction and acceptance of the feedbackOutcome measure is assessed at one month follow-up and three months follow-uptime 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-uptime of measurement: one months and three months after cardiac consultation
Risk perception of physical activity levelOutcome measure is assessed at three months follow-uptime of measurement: three months after cardiac consultation
Somatic symptom severity (PHQ-15)Outcome measure is assessed at one month follow-up and three months follow-uptime 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-uptime of measurement: one months and three months after cardiac consultation
New York Heart Association ClassOutcome measure is assessed at one month follow-up and three months follow-uptime of measurement: one months and three months after cardiac consultation
Canadian Cardiology Society ClassOutcome measure is assessed at one month follow-up and three months follow-uptime 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-uptime of measurement: one months and three months after cardiac consultation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026