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

August 8, 2022 updated by: Dr. Sebastian Kohlmann, Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Risk perception of physical activity level
Time Frame: Outcome measure is assessed at one month follow-up
time of measurement: one month after cardiac consultation
Outcome measure is assessed at one month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk perception of physical activity level
Time Frame: Outcome measure is assessed at three months follow-up
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 Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Adherence to the pedometer
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Satisfaction and acceptance of the feedback
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Depression severity (PHQ-9)
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Anxiety severity (GAD-7)
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Somatic symptom severity (PHQ-15)
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Quality of life (EQ-5D)
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
New York Heart Association Class
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up
Canadian Cardiology Society Class
Time Frame: 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
Outcome measure is assessed at one month follow-up and three months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bernd Löwe, Prof. Dr., Universitatsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1525/100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Disease

Clinical Trials on Patient-targeted individual physical-activity-feedback

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings