Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-29 @ 4:39 PM
Study NCT ID:
NCT02737761
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2016-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Researching Emotions And Cardiac Health
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Developing a Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: Qualitative Research Phase
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH
Brief 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.
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:
1. 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.
2. 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.
3. Identify other barriers to health behavior completion.
4. Explore strategies to enhance positive emotional and cognitive states in HF patients and inquire about the utility of potential PP exercises in these patients.
5. Develop a preliminary PP-based intervention using the above information.
6. Assess the feasibility of our proposed survey-based measures for adherence, psychological health, and physical health in this group of patients.
7. 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.
In this project, the investigators hope to do the following:
1. 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.
2. 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.
3. Identify other barriers to health behavior completion.
4. Explore strategies to enhance positive emotional and cognitive states in HF patients and inquire about the utility of potential PP exercises in these patients.
5. Develop a preliminary PP-based intervention using the above information.
6. Assess the feasibility of our proposed survey-based measures for adherence, psychological health, and physical health in this group of patients.
7. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23HL123607-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |