Researching Emotions And Cardiac Health

NCT02737761 | Completed

• 2 other identifiers: 2015P0000691K23HL123607-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Emotions; Patient Compliance

Keywords

Heart Failure; Positive Psychology; Adherence to Health Behaviors

Outcome Measures

Primary Outcomes (1)

• 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.

  Qualitative data collected at Baseline

Secondary Outcomes (12)

• Changes in PANAS Scores

  Baseline, 12 weeks

• Changes in LOT-R Scores

  Baseline, 12 weeks

• Changes in HADS Scores

  Baseline, 12 weeks

• Changes in KCCQ Scores

  Baseline, 12 weeks

• Changes in SF-12 Scores

  Baseline, 12 weeks

Study Arms (1)

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.

Behavioral: Qualitative Interview and Adherence Measurements

Interventions

Qualitative Interview and Adherence Measurements BEHAVIORAL

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.

Optimal Adherence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Heart Failure; Patient Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Christopher M Celano, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychiatry

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 14, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)