NCT01807442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

5 months

First QC Date

March 4, 2013

Last Update Submit

September 15, 2014

Conditions

Acute Coronary SyndromeEmotionsPatient Compliance

Keywords

Acute Coronary SyndromePositive PsychologyAdherence to Health Behaviors

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • 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.

    12 weeks

Secondary Outcomes (1)

  • Changes in positive affect

    Change from baseline positive affect at 12 weeks

Study Arms (2)

Optimal adherence

OTHER

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.

Other: Qualitative Interview and Adherence

Sub-optimal adherence

OTHER

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.

Other: Qualitative Interview and Adherence

Interventions

Qualitative Interview and AdherenceOTHER

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.

Optimal adherenceSub-optimal adherence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromePatient Compliance

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jeff C Huffman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director of Inpatient Psychiatric Unit

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

US(1)