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

Primary Purpose

Hypertension, Coronary Disease, Cardiac Diseases

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Patient-targeted individual physical-activity-feedback
Pedometer
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring physical activity, patient feedback, risk perception, pedometer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Heart Center, Medical Center Hamburg Eppendorf
  • Cardiologicum Hamburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pedometer+physical-activity-feedback

Pedometer-only

Arm Description

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

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

Outcomes

Primary Outcome Measures

Risk perception of physical activity level
time of measurement: one month after cardiac consultation

Secondary Outcome Measures

Risk perception of physical activity level
time of measurement: three months after cardiac consultation
Physical activity Level (Pedometer, time spent sitting, IPAQ)
time of measurement: one months and three months after cardiac consultation
Adherence to the pedometer
time of measurement: one months and three months after cardiac consultation
Satisfaction and acceptance of the feedback
time of measurement: one months and three months after cardiac consultation
Depression severity (PHQ-9)
time of measurement: one months and three months after cardiac consultation
Anxiety severity (GAD-7)
time of measurement: one months and three months after cardiac consultation
Somatic symptom severity (PHQ-15)
time of measurement: one months and three months after cardiac consultation
Quality of life (EQ-5D)
time of measurement: one months and three months after cardiac consultation
New York Heart Association Class
time of measurement: one months and three months after cardiac consultation
Canadian Cardiology Society Class
time of measurement: one months and three months after cardiac consultation

Full Information

First Posted
June 12, 2016
Last Updated
August 8, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT02802254
Brief Title
Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback.
Acronym
RiskAct
Official Title
Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback: Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Coronary Disease, Cardiac Diseases
Keywords
physical activity, patient feedback, risk perception, pedometer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pedometer+physical-activity-feedback
Arm Type
Experimental
Arm Description
At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback.
Arm Title
Pedometer-only
Arm Type
Active Comparator
Arm Description
Patients use a Pedometer in order to measure their daily step number
Intervention Type
Behavioral
Intervention Name(s)
Patient-targeted individual physical-activity-feedback
Intervention Description
At cardiac consultation receive an individual feedback on their personal physical activity level.
Intervention Type
Device
Intervention Name(s)
Pedometer
Intervention Description
Patients receive a pedometer two weeks prior to cardiac consultation.
Primary Outcome Measure Information:
Title
Risk perception of physical activity level
Description
time of measurement: one month after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up
Secondary Outcome Measure Information:
Title
Risk perception of physical activity level
Description
time of measurement: three months after cardiac consultation
Time Frame
Outcome measure is assessed at three months follow-up
Title
Physical activity Level (Pedometer, time spent sitting, IPAQ)
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Adherence to the pedometer
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Satisfaction and acceptance of the feedback
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Depression severity (PHQ-9)
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Anxiety severity (GAD-7)
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Somatic symptom severity (PHQ-15)
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Quality of life (EQ-5D)
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
New York Heart Association Class
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up
Title
Canadian Cardiology Society Class
Description
time of measurement: one months and three months after cardiac consultation
Time Frame
Outcome measure is assessed at one month follow-up and three months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Löwe, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Study Director
Facility Information:
Facility Name
University Heart Center, Medical Center Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Cardiologicum Hamburg
City
Hamburg
ZIP/Postal Code
22041
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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