HypertensionPhase 2/3RiskActNCT02802254
Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback.
A Phase 2/3 study testing Patient-targeted individual physical-activity-feedback and Pedometer in people with Hypertension and Coronary Disease, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Coronary Disease, Cardiac Diseases
- What is being tested?
- Patient-targeted individual physical-activity-feedback and Pedometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2016to Jun 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Heart Center, Medical Center Hamburg Eppendorf
Hamburg, 20246
Cardiologicum Hamburg
Hamburg, 22041
About this study
Official title: 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.
- Conditions
- Hypertension, Coronary Disease, Cardiac Diseases
- Being tested
- Patient-targeted individual physical-activity-feedback, Pedometer
- Keywords
- physical activity, patient feedback, risk perception, pedometer
- Medical subject headings
- Hypertension, Coronary Disease, Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-targeted individual physical-activity-feedbackBehavioural
At cardiac consultation receive an individual feedback on their personal physical activity level.
PedometerDevice
Patients receive a pedometer two weeks prior to cardiac consultation.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer+physical-activity-feedback | Experimental | At cardiac consultation patients receive a patient-targeted individual physical-activity-feedback. Receives: Behavioral: Patient-targeted individual physical-activity-feedback; Device: Pedometer |
| Pedometer-only | Active comparator | Patients use a Pedometer in order to measure their daily step number Receives: Device: Pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk perception of physical activity level
time of measurement: one month after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up
Secondary outcomes (10)
Risk perception of physical activity level
time of measurement: three months after cardiac consultation
Measured: Outcome measure is assessed at three months follow-up
Physical activity Level (Pedometer, time spent sitting, IPAQ)
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Adherence to the pedometer
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Satisfaction and acceptance of the feedback
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Depression severity (PHQ-9)
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Anxiety severity (GAD-7)
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Somatic symptom severity (PHQ-15)
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Quality of life (EQ-5D)
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
New York Heart Association Class
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Canadian Cardiology Society Class
time of measurement: one months and three months after cardiac consultation
Measured: Outcome measure is assessed at one month follow-up and three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sebastian Kohlmann, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Bernd Löwe, Prof. Dr., Study director, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802254
- Sponsor's protocol ID
- 1525/100
- Acronym
- RiskAct
- Status last verified
- Aug 2022
- First submitted
- 12 Jun 2016
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Risk Perception of Physical Activity Using Patient-targeted Feedback: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02802254
- Acronym / sponsor ID
- RiskAct / 1525/100
- Conditions
- Hypertension, Coronary Disease, Cardiac Diseases
- Keywords
- physical activity, patient feedback, risk perception, pedometer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer+physical-activity-feedback | Experimental | Behavioral: Patient-targeted individual physical-activity-feedback, Device: PedometerAt cardiac consultation patients receive a patient-targeted individual physical-activity-feedback. |
| Pedometer-only | Active comparator | Device: PedometerPatients use a Pedometer in order to measure their daily step number |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-targeted individual physical-activity-feedbackAt cardiac consultation receive an individual feedback on their personal physical activity level. | Behavioural | Pedometer+physical-activity-feedback |
| PedometerPatients receive a pedometer two weeks prior to cardiac consultation. | Device | Pedometer+physical-activity-feedback, Pedometer-only |
Primary outcome
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
10 secondary outcomes
Risk perception of physical activity level
Time frame: 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
Adherence to the pedometer
Time frame: 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
Depression severity (PHQ-9)
Time frame: 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
Somatic symptom severity (PHQ-15)
Time frame: 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
New York Heart Association Class
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Löwe, Prof. Dr. study director
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Patient-targeted individual physical-activity-feedback and Pedometer in people with Hypertension and Coronary Disease, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk perception of physical activity level (time frame: Outcome measure is assessed at one month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.