Congestive Heart FailureREACHNCT02737761
Researching Emotions And Cardiac Health
A study testing Qualitative Interview and Adherence Measurements in people with Congestive Heart Failure and Emotions, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of the study is to understand how positive emotions (e.g., optimism, happiness) are associated with health behavior adherence in patients with heart failure (HF), as well as whether performing exercises to improve positive emotions may help to improve health behavior adherence as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Emotions, Patient Compliance
- What is being tested?
- Qualitative Interview and Adherence Measurements
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with NYHA class II or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center. Investigators will enroll subjects who develop mild to moderate HF symptoms during activity but not at rest. NYHA class II/III HF patients comprise the majority of subjects in studies that identify links between physical activity and improved exercise capacity, QoL, and survival making them an ideal study population. HF diagnosis, clinical stability, and NYHA class will be clarified with the inpatient or outpatient cardiology team.
Who cannot join
- Cognitive deficits impeding a subject's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research subjects.
- Medical conditions precluding interviews or likely to lead to death within 6 months.
- Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: Qualitative Research Phase
The purpose of the study is to understand how positive emotions (e.g., optimism, happiness) are associated with health behavior adherence in patients with heart failure (HF), as well as whether performing exercises to improve positive emotions may help to improve health behavior adherence as well.
Read the detailed description
The investigators are proposing a study that will specifically and innovatively focus on the development of a novel positive psychology intervention that is adapted for patients with HF. The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects for the study, with patients who have a diagnosis of HF serving as potential subjects. The investigators will interview 30 HF patients within two weeks of enrollment in the study, and again three months later.
In this project, the investigators hope to do the following:
- Identify, through qualitative research, deficits in positive emotional and cognitive states in clinically stable patients with New York Heart Association (NYHA) class II or III HF.
- Examine potential links between positive emotional deficits and impaired health behaviors (low sodium diet, physical activity, medication adherence), as well as links between positive emotional sufficiency and successful health behaviors.
- Identify other barriers to health behavior completion.
- Explore strategies to enhance positive emotional and cognitive states in HF patients and inquire about the utility of potential PP exercises in these patients.
- Develop a preliminary PP-based intervention using the above information.
- Assess the feasibility of our proposed survey-based measures for adherence, psychological health, and physical health in this group of patients.
- Explore the feasibility of using methods to objectively measure medication adherence and physical activity (via electronic pillcaps and accelerometers, respectively) in this population.
Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
Participants will undergo an open-ended, semi-structured interview within 2 weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. Participants will then undergo another qualitative interview and repeat the battery of questionnaires again at 12 weeks.
Participants will wear an Actigraph accelerometer for 2 weeks at Baseline and again at 12 weeks to measure physical activity, and will also use a MEMSCap electronic pill counter throughout the study to measure medication adherence, respectively.
- Conditions
- Congestive Heart Failure, Emotions, Patient Compliance
- Being tested
- Qualitative Interview and Adherence Measurements
- Keywords
- Heart Failure, Positive Psychology, Adherence to Health Behaviors
- Medical subject headings
- Heart Failure, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Interview and Adherence MeasurementsBehavioural
Subjects will undergo an open-ended, semi-structured interview within two weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. This interview will be completed again 12 weeks later. Subjects will complete the MOS SAS, Automated Self-Administered 24-hour recall (ASA24), Life Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety and Depression Scale (HADS), Kansas City Cardiomyopathy Questionnaire (KCCQ), and Medical Outcomes Study Short Form-12 (SF-12) at baseline and again at 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Optimal Adherence | Experimental | Participants will all undergo a qualitative interview and adherence measurements at baseline and 12 weeks after hospital discharge.
In person the participants will receive a MEMSCaps device and an Actigraph accelerometer. They will be asked to begin wearing the accelerometer after their initial interview and to begin using the MEMSCaps device once they arrive at home. Participants will use the MEMSCap throughout the entire study and will wear the Actigraph for 2 weeks at baseline and again at 12 weeks. Receives: Behavioral: Qualitative Interview and Adherence Measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes related to how deficits in positive emotional states are associated with health behavior adherence
Subjects will complete a structured interview at baseline, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, financial) to completing such behaviors.
Measured: Qualitative data collected at Baseline
Secondary outcomes (12)
Changes in PANAS Scores
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect.
Measured: Baseline, 12 weeks
Changes in LOT-R Scores
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
Measured: Baseline, 12 weeks
Changes in HADS Scores
The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
Measured: Baseline, 12 weeks
Changes in KCCQ Scores
The Kansas City Cardiomyopathy Questionnaire is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms.
Measured: Baseline, 12 weeks
Changes in SF-12 Scores
The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past.
Measured: Baseline, 12 weeks
Changes in MOS SAS Scores
Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
Measured: Baseline, 12 weeks
Changes in daily sodium intake (as measured with the ASA24)
The Automated Self-administered 24-hour recall (ASA24) is an online assessment tool based on the U.S. Department of Agriculture's (USDA) Automated Multi-Pass Method (AMPM). It will be used to calculate daily sodium intake.
Measured: Baseline, 12 weeks
Medication Adherence (MEMSCaps)
The MEMSCap has been used in patients with HF and is the most prevalent system for measuring adherence to PO medications. Investigators will measure adherence to a once-daily prescribed medication (aspirin, thiazide diuretic, statin, ACE inhibitor, or another once-daily cardiac medication, chosen in that order). Data will be continuously collected, and adherence noted by presence of bottle opening each day. Participants will use the pill counter throughout the study.
Measured: 12 weeks
Physical Activity Adherence (Actigraph)
ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer to assess the feasibility of doing so and to ensure adequate capture of physical activity.
Measured: 12 weeks
Feasibility of MEMSCaps
Feasibility will be measured by examining the rates of use of the MEMSCap.
Measured: Baseline and 12 weeks
Feasibility of Actigraph
Feasibility will be measured by examining the rates of use of the Actigraph.
Measured: Baseline and 12 weeks
Themes related to how deficits in positive emotional states are associated with health behavior adherence at 12 weeks
Subjects will complete a structured interview at 12 weeks, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, financial) to completing such behaviors.
Measured: Qualitative data collected at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Celano, Massachusetts General Hospital
- Investigators
- Christopher M Celano, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737761
- Sponsor's protocol ID
- 2015P000069
- Other IDs
- 1K23HL123607-01A1
- Acronym
- REACH
- Status last verified
- Oct 2016
- First submitted
- 5 Apr 2016
- Last updated
- 27 Oct 2016
- 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 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: Qualitative Research Phase
- ClinicalTrials.gov ID
- NCT02737761
- Acronym / sponsor ID
- REACH / 2015P000069
- Conditions
- Congestive Heart Failure, Emotions, Patient Compliance
- Keywords
- Heart Failure, Positive Psychology, Adherence to Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Apr 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 purpose of the study is to understand how positive emotions (e.g., optimism, happiness) are associated with health behavior adherence in patients with heart failure (HF), as well as whether performing exercises to improve positive emotions may help to improve health behavior adherence as well.
Detailed description
The investigators are proposing a study that will specifically and innovatively focus on the development of a novel positive psychology intervention that is adapted for patients with HF. The MGH inpatient units and MGH Heart Center outpatients will serve as the source of subjects for the study, with patients who have a diagnosis of HF serving as potential subjects. The investigators will interview 30 HF patients within two weeks of enrollment in the study, and again three months later.
In this project, the investigators hope to do the following:
- Identify, through qualitative research, deficits in positive emotional and cognitive states in clinically stable patients with New York Heart Association (NYHA) class II or III HF.
- Examine potential links between positive emotional deficits and impaired health behaviors (low sodium diet, physical activity, medication adherence), as well as links between positive emotional sufficiency and successful health behaviors.
- Identify other barriers to health behavior completion.
- Explore strategies to enhance positive emotional and cognitive states in HF patients and inquire about the utility of potential PP exercises in these patients.
- Develop a preliminary PP-based intervention using the above information.
- Assess the feasibility of our proposed survey-based measures for adherence, psychological health, and physical health in this group of patients.
- Explore the feasibility of using methods to objectively measure medication adherence and physical activity (via electronic pillcaps and accelerometers, respectively) in this population.
Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).
Participants will undergo an open-ended, semi-structured interview within 2 weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. Participants will then undergo another qualitative interview and repeat the battery of questionnaires again at 12 weeks.
Participants will wear an Actigraph accelerometer for 2 weeks at Baseline and again at 12 weeks to measure physical activity, and will also use a MEMSCap electronic pill counter throughout the study to measure medication adherence, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimal Adherence | Experimental | Behavioral: Qualitative Interview and Adherence MeasurementsParticipants will all undergo a qualitative interview and adherence measurements at baseline and 12 weeks after hospital discharge. In person the participants will receive a MEMSCaps device and an Actigraph accelerometer. They will be asked to begin wearing the accelerometer after their initial interview and to begin using the MEMSCaps device once they arrive at home. Participants will use the MEMSCap throughout the entire study and will wear the Actigraph for 2 weeks at baseline and again at 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with NYHA class II or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center. Investigators will enroll subjects who develop mild to moderate HF symptoms during activity but not at rest. NYHA class II/III HF patients comprise the majority of subjects in studies that identify links between physical activity and improved exercise capacity, QoL, and survival making them an ideal study population. HF diagnosis, clinical stability, and NYHA class will be clarified with the inpatient or outpatient cardiology team.
Key exclusion criteria (3 listed)
- Cognitive deficits impeding a subject's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research subjects.
- Medical conditions precluding interviews or likely to lead to death within 6 months.
- Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.
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 |
|---|---|---|
| Qualitative Interview and Adherence MeasurementsSubjects will undergo an open-ended, semi-structured interview within two weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. This interview will be completed again 12 weeks later. Subjects will complete the MOS SAS, Automated Self-Administered 24-hour recall (ASA24), Life Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety and Depression Scale (HADS), Kansas City Cardiomyopathy Questionnaire (KCCQ), and Medical Outcomes Study Short Form-12 (SF-12) at baseline and again at 12 weeks. | Behavioural | Optimal Adherence |
Primary outcome
Themes related to how deficits in positive emotional states are associated with health behavior adherence
Time frame: Qualitative data collected at Baseline
Subjects will complete a structured interview at baseline, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers (e.g., logistic, financial) to completing such behaviors.
12 secondary outcomes
Changes in PANAS Scores
Time frame: Baseline, 12 weeks
Changes in LOT-R Scores
Time frame: Baseline, 12 weeks
Changes in HADS Scores
Time frame: Baseline, 12 weeks
Changes in KCCQ Scores
Time frame: Baseline, 12 weeks
Changes in SF-12 Scores
Time frame: Baseline, 12 weeks
Changes in MOS SAS Scores
Time frame: Baseline, 12 weeks
Changes in daily sodium intake (as measured with the ASA24)
Time frame: Baseline, 12 weeks
Medication Adherence (MEMSCaps)
Time frame: 12 weeks
Physical Activity Adherence (Actigraph)
Time frame: 12 weeks
Feasibility of MEMSCaps
Time frame: Baseline and 12 weeks
Feasibility of Actigraph
Time frame: Baseline and 12 weeks
Themes related to how deficits in positive emotional states are associated with health behavior adherence at 12 weeks
Time frame: Qualitative data collected at 12 weeks
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 27 Oct 2016.
- 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.
Christopher M Celano, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Interview and Adherence Measurements in people with Congestive Heart Failure and Emotions, run by Massachusetts General Hospital 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 1 inclusion and 3 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 27 Oct 2016. 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?
Themes related to how deficits in positive emotional states are associated with health behavior adherence (time frame: Qualitative data collected at Baseline). 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 27 Oct 2016.