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

NCT ID: NCT02802254

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension Coronary Disease Cardiac Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pedometer+physical-activity-feedback

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

Group Type EXPERIMENTAL

Patient-targeted individual physical-activity-feedback

Intervention Type BEHAVIORAL

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

Pedometer

Intervention Type DEVICE

Patients receive a pedometer two weeks prior to cardiac consultation.

Pedometer-only

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

Group Type ACTIVE_COMPARATOR

Pedometer

Intervention Type DEVICE

Patients receive a pedometer two weeks prior to cardiac consultation.

Interventions

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Patient-targeted individual physical-activity-feedback

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

Intervention Type BEHAVIORAL

Pedometer

Patients receive a pedometer two weeks prior to cardiac consultation.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sebastian Kohlmann

Dr. rer. nat. Dipl. Psych.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernd Löwe, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Heart Center, Medical Center Hamburg Eppendorf

Hamburg, , Germany

Site Status

Cardiologicum Hamburg

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1525/100

Identifier Type: -

Identifier Source: org_study_id

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