NCT02802254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

10 months

First QC Date

June 12, 2016

Last Update Submit

August 8, 2022

Conditions

HypertensionCoronary DiseaseCardiac Diseases

Keywords

physical activitypatient feedbackrisk perceptionpedometer

Outcome Measures

Primary Outcomes (1)

  • Risk perception of physical activity level

    time of measurement: one month after cardiac consultation

    Outcome measure is assessed at one month follow-up

Secondary Outcomes (10)

  • Risk perception of physical activity level

    Outcome measure is assessed at three months follow-up

  • Physical activity Level (Pedometer, time spent sitting, IPAQ)

    Outcome measure is assessed at one month follow-up and three months follow-up

  • Adherence to the pedometer

    Outcome measure is assessed at one month follow-up and three months follow-up

  • Satisfaction and acceptance of the feedback

    Outcome measure is assessed at one month follow-up and three months follow-up

  • Depression severity (PHQ-9)

    Outcome measure is assessed at one month follow-up and three months follow-up

  • +5 more secondary outcomes

Study Arms (2)

Pedometer+physical-activity-feedback

EXPERIMENTAL

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

Behavioral: Patient-targeted individual physical-activity-feedbackDevice: Pedometer

Pedometer-only

ACTIVE COMPARATOR

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

Device: Pedometer

Interventions

Patient-targeted individual physical-activity-feedbackBEHAVIORAL

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

Pedometer+physical-activity-feedback
PedometerDEVICE

Patients receive a pedometer two weeks prior to cardiac consultation.

Pedometer+physical-activity-feedbackPedometer-only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Heart Center, Medical Center Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Cardiologicum Hamburg

Hamburg, 22041, Germany

Location

MeSH Terms

Conditions

HypertensionCoronary DiseaseHeart DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesMyocardial IschemiaBehavior

Study Officials

  • Bernd Löwe, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. rer. nat. Dipl. Psych.

Study Record Dates

First Submitted

June 12, 2016

First Posted

June 16, 2016

Study Start

August 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)