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Positive Psychology to Improve Cardiac Health Behaviors (PEACE)

Primary Purpose

Acute Coronary Syndrome, Emotions, Patient Compliance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Qualitative Interview and Adherence
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Positive Psychology, Adherence to Health Behaviors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission to Massachusetts General Hospital cardiac floors (Ellison 9, 10, 11)
  • Age 18 or older
  • Admitted with myocardial infarction or unstable angina
  • Score of less than 15 --OR-- greater than or equal to 15 on the adherence scale
  • Ability to read and write in English

Exclusion Criteria:

  • Cognitive deficits as assessed by a 6-item screen
  • Medical conditions that prevent interviewing or are likely to lead to death within 6 months

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Optimal adherence

Sub-optimal adherence

Arm Description

Participants receive the qualitative interview and adherence intervention. This arm includes participants with scores of greater than or equal to 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of greater than or equal to 15 suggests optimal adherence to health behaviors.

Participants receive the qualitative interview and adherence intervention. This arm includes participants with scores of less than 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of less than 15 suggests sub-optimal adherence to health behaviors.

Outcomes

Primary Outcome Measures

Deficits in positive affect
Qualitative data: The investigators will extract information from 2 quantitative interviews to learn about participants' deficits in positive affect. Quantitative data: Life Orientation Test-Revised, Positive And Negative Affect Scale, Hospital Anxiety and Depression Scale.
Barriers to health behaviors
Qualitative data: The investigators will extract information from 2 qualitative interviews to learn about participants' barriers to completing health behaviors. Quantitative data: Participants will receive a pill bottle that tracks when they take their aspirin. Participants will also receive a step counter to wear for two weeks.

Secondary Outcome Measures

Changes in positive affect
Qualitative data: The investigators will compare information from the 2 qualitative interviews to learn about participants' changes in positive affect.

Full Information

First Posted
March 4, 2013
Last Updated
September 15, 2014
Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01807442
Brief Title
Positive Psychology to Improve Cardiac Health Behaviors
Acronym
PEACE
Official Title
Developing a Positive Psychology Intervention to Improve Cardiac Health Behaviors: Qualitative Research Phase
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to understand peoples' positive emotions, like how optimistic or grateful they feel, after they have had a heart problem. The investigators want to determine whether positive emotions affect peoples' ability to follow recommendations, like following a healthy diet, exercising, and taking medication.
Detailed Description
The investigators aim to develop a novel positive psychology intervention that is adapted for patients hospitalized for an acute coronary syndrome (ACS). A treatment cultivating positive emotions in this vulnerable population could provide broad and significant health benefits, and may have distinct-and more powerful-effects than simply attempting to dampen negative emotions. In this study, the investigators will use mixed methods (qualitative and quantitative) to take the first step towards developing such a treatment, with a major focus on the qualitative aspects of the patient assessments/interviews. In this project, the investigators hope to do the following: Identify, through qualitative research, deficits in positive emotional and cognitive states prior to, during, and after cardiac admission: What positive emotions are lacking in hospitalized ACS patients? Explore strategies to enhance positive emotional and cognitive states in ACS patients. Identify links between these positive states and health behavior (diet, physical activity, and medication). Identify other barriers to compliance with health behaviors. What other factors adversely influence compliance with health behaviors in this population? Use quantitative measures of positive affect to ensure that the investigators are adequately capturing information about optimism and other positive states Develop a preliminary positive psychology-based intervention using the above information Explore the feasibility of using methods to objectively measure aspirin adherence and physical activity in this population. To accomplish these goals, the investigators will interview 30 ACS patients during admission to the inpatient cardiac unit and 12 weeks after discharge. The investigators will identify 15 patients who demonstrate suboptimal adherence as reported by the Medical Outcomes Study Specific Adherence Scale (MOS-SAS) and 15 patients who demonstrate good adherence to health-related behaviors. For these interviews, the investigators will first ask about positive emotional states that patients have experienced. the investigators will then inquire about potential ideas for increasing these positive emotional states by asking patients what has worked for them in the past and what they have noticed seems to work for others. The investigators will also describe some positive psychology exercises to the patients and ask whether they think those exercises would be effective at increasing positive emotional states. Next, the investigators will ask about health behaviors in which the patient has engaged. The investigators will explore the relationship between these behaviors and positive emotional states. Finally, the investigators will explore with patients some barriers to completing health behaviors and solicit suggestions for overcoming or mitigating these barriers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Emotions, Patient Compliance
Keywords
Acute Coronary Syndrome, Positive Psychology, Adherence to Health Behaviors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal adherence
Arm Type
Other
Arm Description
Participants receive the qualitative interview and adherence intervention. This arm includes participants with scores of greater than or equal to 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of greater than or equal to 15 suggests optimal adherence to health behaviors.
Arm Title
Sub-optimal adherence
Arm Type
Other
Arm Description
Participants receive the qualitative interview and adherence intervention. This arm includes participants with scores of less than 15 on the Medical Outcomes Study Specific Adherence Scale. This scale ranges from a score of 3 (extremely low adherence to health behaviors) to a score of 18 (extremely high adherence to health behaviors). A score of less than 15 suggests sub-optimal adherence to health behaviors.
Intervention Type
Other
Intervention Name(s)
Qualitative Interview and Adherence
Intervention Description
All participants receive the same intervention. The intervention involves two qualitative interviews per participant. The first interview occurs in the hospital, and the second interview occurs at 12 weeks. Participants also receive a pill bottle that tracks when they take their aspirin. They will also receive a step counter to use for two weeks at the end of the study.
Primary Outcome Measure Information:
Title
Deficits in positive affect
Description
Qualitative data: The investigators will extract information from 2 quantitative interviews to learn about participants' deficits in positive affect. Quantitative data: Life Orientation Test-Revised, Positive And Negative Affect Scale, Hospital Anxiety and Depression Scale.
Time Frame
12 weeks
Title
Barriers to health behaviors
Description
Qualitative data: The investigators will extract information from 2 qualitative interviews to learn about participants' barriers to completing health behaviors. Quantitative data: Participants will receive a pill bottle that tracks when they take their aspirin. Participants will also receive a step counter to wear for two weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in positive affect
Description
Qualitative data: The investigators will compare information from the 2 qualitative interviews to learn about participants' changes in positive affect.
Time Frame
Change from baseline positive affect at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to Massachusetts General Hospital cardiac floors (Ellison 9, 10, 11) Age 18 or older Admitted with myocardial infarction or unstable angina Score of less than 15 --OR-- greater than or equal to 15 on the adherence scale Ability to read and write in English Exclusion Criteria: Cognitive deficits as assessed by a 6-item screen Medical conditions that prevent interviewing or are likely to lead to death within 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Positive Psychology to Improve Cardiac Health Behaviors

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