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Completed

NCT Number: NCT02802254

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

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.

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Key information

Conditions

Hypertension Behavior Cardiac Diseases Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cardiologicum Hamburg, Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient-targeted individual physical-activity-feedback

Behavioral

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

Pedometer

Device

Patients receive a pedometer two weeks prior to cardiac consultation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: RiskAct

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2016
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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