Coronary Artery DiseaseNCT03629158
Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
A study testing CLIMB intervention in people with Coronary Artery Disease and Ischemic Heart Disease, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease, Coronary Heart Disease
- What is being tested?
- CLIMB intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to 9 Jul 2019
- Phase
- Interventional
- 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 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CAD as indicated by history of at least one myocardial infarction, at least one coronary artery bypass graft surgery, at least one coronary stent, and/or at least one coronary vessel with stenosis greater than or equal to 70%.
- Stable status as indicated by no myocardial infarctions, unstable angina, or other acute coronary syndromes within the past 3 months, no coronary revascularizations within the past 3 months, and no planned revascularizations.
Who cannot join
- Age < 30 years or > 79 years
- Cognitive impairment as indicated by diagnosis in medical chart
- Psychotic symptoms as indicated by diagnosis in medical chart
- Any documented non-skin malignancy, malignant melanoma, or advanced kidney disease (indicated by stage 4 or 5 or on dialysis)
- Ejection fraction < 30%
- Physician determination of inappropriateness for study, due to anticipated life expectancy of <1 year, presence of a survival limiting or uncontrolled illness, and/or hemodynamically important valvular disease.
Show all 10Show fewer
- Women who are pregnant or breast feeding
- Non-English-speaking
- Participation in another clinical trial concurrently or within 30 days before screening
- Psychological safety concerns, including plans to harm oneself within the past two months and/or suicide attempt within the past year
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). The investigators hypothesize that, compared to the TAU group, participants receiving the intervention will 1) experience greater confidence in managing their cardiac disease, as indicated by perceived self-efficacy and illness perceptions; 2) experience greater psychological adjustment as indicated by depressive, anxious, and demoralization symptoms; 3) experience greater engagement in health behaviors including healthy eating and physical activity.
Read the detailed description
Participants will be randomly assigned to one of two research groups: the intervention group (IG) and the treatment as usual (TAU) group. The IG will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB"). CLIMB is a 3-session (2-week) intervention. One session includes health behavior feedback, and patient selection of relevant lifestyle modules based on values clarification. In the remaining two sessions, participants will complete two of five elective lifestyle modules: Healthy Eating, Physical Activity, Reducing Stress and Worry, Mood Management, and Smoking Cessation Education. Intervention components include information provision, goal setting, problem solving, and elements of cognitive behavioral therapy.
Participants in the IG will complete a Baseline assessment, three intervention sessions, a 30-day follow-up, and a 3-month follow-up. Baseline and Session 1 will take place on the same day. Sessions 1, 2, and 3 will be spaced approximately one week apart from one another (1 week in-between Sessions 1 and 2, and 1 week in-between Sessions 2 and 3). The 30-day follow-up will occur approximately 30-days after Session 3. The 3-month follow-up will occur approximately 3 months after Session 3. Assessment measures will be filled out at Baseline, at Post-treatment (end of Session 3), at 30-day follow-up, and at 3-month follow-up. The TAU group will fill out assessment measures at comparable time points, with the exception that there will be no 3-month follow-up. After completing their 30-day follow-up measures, TAU members may elect to receive the CLIMB intervention.
- Being tested
- CLIMB intervention
- Keywords
- Behavioral Medicine, Clinical Trial, Cardiology, Health Behavior, Healthy Lifestyle, Self Efficacy
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIMB interventionBehavioural
The intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks. Sessions range from 1-2 hours in length, including questionnaire completion. Participants will be given information and taught relevant skills to increase engagement in lifestyle behaviors relevant to cardiac health.
| Study group | Role | What they receive |
|---|---|---|
| CLIMB intervention | Experimental | The intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks. Receives: Behavioral: CLIMB intervention |
| Treatment as usual (TAU) | No intervention | The TAU group will continue to receive their regular medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy for managing coronary artery disease
Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 1 (minimum) to 10 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).
Measured: 2-weeks/post-treatment
Self-efficacy for managing coronary artery disease
Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 6 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).
Measured: 30-day follow-up
Illness perceptions
Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).
Measured: 2-weeks/post-treatment
Illness perceptions
Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).
Measured: 30-day follow-up
Participant-reported depressive symptoms
The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).
Measured: 2-weeks/post-treatment
Participant-reported depressive symptoms
The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).
Measured: 30-day follow-up
Participant-reported anxiety symptoms
The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).
Measured: 2-weeks/post-treatment
Participant-reported anxiety symptoms
The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).
Measured: 30-day follow-up
Secondary outcomes (6)
Participant-reported symptoms of demoralization
Symptoms of demoralization will be measured using the Demoralization Scale-II (DS-II). Scale scores range from 0 (minimum) to 32 (maximum), with higher scores indicating more demoralization (i.e., a worse outcome).
Measured: 2-weeks/post-treatment, 30-day follow-up
Dietary patterns as measured using the brief dietary assessment and intervention tool: the Starting the Conversation (STC) questionnaire.
Participants will report dietary patterns using the Starting the Conversation (STC) questionnaire. Scale scores range from 0 (minimum) to 16 (maximum) with lower scores indicating healthier dietary patterns (i.e., a better outcome).
Measured: 2-weeks/post-treatment, 30-day follow-up
Physical activity patterns
The Global Physical Activity Questionnaire (GPAQ) will be administered to participants as a measure of physical activity behavior.
Measured: 2-weeks/post-treatment, 30-day follow-up
Number of cigarettes smoked per week over the past two weeks
Participants who smoked a cigarette in the past month will complete a smoking questionnaire that assesses the number of cigarettes smoked per week over the past two weeks, motivation and readiness to quit smoking, in addition to interest in receiving smoking cessation referrals.
Measured: 2-weeks/post-treatment, 30-day follow-up
Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)
Participant diet self-efficacy will be assessed with the scenario-based measure The Diet Self Efficacy Scale (DIET-SE). Scale scores range from 0 (minimum) to 44 (maximum), with higher scores indicating greater self-efficacy/confidence in dieting situations (i.e., a better outcome).
Measured: 2-weeks/post-treatment, 30-day follow-up
Confidence in exercising consistently (i.e., Exercise self-efficacy)
Participant self-efficacy for exercise will be measured using the Exercise Confidence Survey (ECS). Scores range from 12 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy for exercise (i.e., a better outcome).
Measured: 2-weeks/post-treatment, 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start11 Sep 2018
- Primary completion27 Jun 2019
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsea Wiener, University of Central Florida
- Investigators
- Chelsea H. Wiener, MS, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629158
- Sponsor's protocol ID
- SBE-18-14085
- Status last verified
- Jul 2019
- First submitted
- 31 Jul 2018
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Behavioral Health Intervention Program for Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03629158
- Acronym / sponsor ID
- SBE-18-14085
- Keywords
- Behavioral Medicine, Clinical Trial, Cardiology, Health Behavior, Healthy Lifestyle, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- 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 purpose of this study is to examine the effectiveness of a lifestyle intervention for patients living with stable coronary artery disease (CAD). One group will receive the the intervention, and the other will receive treatment as usual (TAU). The investigators hypothesize that, compared to the TAU group, participants receiving the intervention will 1) experience greater confidence in managing their cardiac disease, as indicated by perceived self-efficacy and illness perceptions; 2) experience greater psychological adjustment as indicated by depressive, anxious, and demoralization symptoms; 3) experience greater engagement in health behaviors including healthy eating and physical activity.
Detailed description
Participants will be randomly assigned to one of two research groups: the intervention group (IG) and the treatment as usual (TAU) group. The IG will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB"). CLIMB is a 3-session (2-week) intervention. One session includes health behavior feedback, and patient selection of relevant lifestyle modules based on values clarification. In the remaining two sessions, participants will complete two of five elective lifestyle modules: Healthy Eating, Physical Activity, Reducing Stress and Worry, Mood Management, and Smoking Cessation Education. Intervention components include information provision, goal setting, problem solving, and elements of cognitive behavioral therapy.
Participants in the IG will complete a Baseline assessment, three intervention sessions, a 30-day follow-up, and a 3-month follow-up. Baseline and Session 1 will take place on the same day. Sessions 1, 2, and 3 will be spaced approximately one week apart from one another (1 week in-between Sessions 1 and 2, and 1 week in-between Sessions 2 and 3). The 30-day follow-up will occur approximately 30-days after Session 3. The 3-month follow-up will occur approximately 3 months after Session 3. Assessment measures will be filled out at Baseline, at Post-treatment (end of Session 3), at 30-day follow-up, and at 3-month follow-up. The TAU group will fill out assessment measures at comparable time points, with the exception that there will be no 3-month follow-up. After completing their 30-day follow-up measures, TAU members may elect to receive the CLIMB intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLIMB intervention | Experimental | Behavioral: CLIMB interventionThe intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks. |
| Treatment as usual (TAU) | No intervention | –The TAU group will continue to receive their regular medical care. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CAD as indicated by history of at least one myocardial infarction, at least one coronary artery bypass graft surgery, at least one coronary stent, and/or at least one coronary vessel with stenosis greater than or equal to 70%.
- Stable status as indicated by no myocardial infarctions, unstable angina, or other acute coronary syndromes within the past 3 months, no coronary revascularizations within the past 3 months, and no planned revascularizations.
Key exclusion criteria (10 listed)
- Age < 30 years or > 79 years
- Cognitive impairment as indicated by diagnosis in medical chart
- Psychotic symptoms as indicated by diagnosis in medical chart
- Any documented non-skin malignancy, malignant melanoma, or advanced kidney disease (indicated by stage 4 or 5 or on dialysis)
- Ejection fraction < 30%
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 |
|---|---|---|
| CLIMB interventionThe intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors ("CLIMB") intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks. Sessions range from 1-2 hours in length, including questionnaire completion. Participants will be given information and taught relevant skills to increase engagement in lifestyle behaviors relevant to cardiac health. | Behavioural | CLIMB intervention |
Primary outcome
Self-efficacy for managing coronary artery disease
Time frame: 2-weeks/post-treatment
Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 1 (minimum) to 10 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).
Self-efficacy for managing coronary artery disease
Time frame: 30-day follow-up
Participants will complete the Self-Efficacy for Managing Chronic Disease Scale-6 (SEMCD-6) to assess self-efficacy in managing coronary artery disease. Scale scores range from 6 (minimum) to 60 (maximum), with higher scores indicating greater self-efficacy in managing chronic disease (i.e., a better outcome).
Illness perceptions
Time frame: 2-weeks/post-treatment
Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).
Illness perceptions
Time frame: 30-day follow-up
Participants will complete the Brief Illness Perception Questionnaire (B-IPQ) as a measure of how threatening they perceive their coronary artery disease to be. Scale scores range from 0 (minimum) to 80 (maximum), with higher scores indicating more threatening illness perceptions (i.e., a worse outcome).
Participant-reported depressive symptoms
Time frame: 2-weeks/post-treatment
The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).
Participant-reported depressive symptoms
Time frame: 30-day follow-up
The Patient Health Questionnaire-9 (PHQ-9) will be administered to assess depressive symptoms. Scale scores range from 0 (minimum) to 27 (maximum) with higher scores indicating elevated depressive symptoms (i.e., a worse outcome).
Participant-reported anxiety symptoms
Time frame: 2-weeks/post-treatment
The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).
Participant-reported anxiety symptoms
Time frame: 30-day follow-up
The Generalized Anxiety Disorder-7 (GAD-7) will be administered to assess anxious symptoms. Scale scores range from 0 (minimum) to 21 (maximum), with higher scores indicating elevated levels of anxiety symptoms (i.e., a worse outcome).
6 secondary outcomes
Participant-reported symptoms of demoralization
Time frame: 2-weeks/post-treatment, 30-day follow-up
Dietary patterns as measured using the brief dietary assessment and intervention tool: the Starting the Conversation (STC) questionnaire.
Time frame: 2-weeks/post-treatment, 30-day follow-up
Physical activity patterns
Time frame: 2-weeks/post-treatment, 30-day follow-up
Number of cigarettes smoked per week over the past two weeks
Time frame: 2-weeks/post-treatment, 30-day follow-up
Confidence in resisting over-eating and unhealthy foods (i.e., Diet self-efficacy)
Time frame: 2-weeks/post-treatment, 30-day follow-up
Confidence in exercising consistently (i.e., Exercise self-efficacy)
Time frame: 2-weeks/post-treatment, 30-day 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 2 Aug 2019.
- 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.
Chelsea H. Wiener, MS principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLIMB intervention in people with Coronary Artery Disease and Ischemic Heart Disease, run by University of Central Florida at 1 site in United States.
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 2 inclusion and 10 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Self-efficacy for managing coronary artery disease (time frame: 2-weeks/post-treatment). The study lists 8 primary outcomes in all. 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 2 Aug 2019.