NCT01315834

Brief Summary

The main purpose of this study is to examine the contribution of personality traits to marital satisfaction and well -being among couples coping with Coronary Heart Disease (CHD) and couples from the general population, and to health promoting behaviors and physical recovery among the ill partners.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 11, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

3.7 years

First QC Date

January 11, 2011

Last Update Submit

March 16, 2012

Conditions

Coronary Heart Disease (CHD)

Outcome Measures

Primary Outcomes (5)

  • Patients' medication adherence

    Medication adherence: the number of prescriptions filled as a function of the frequency of the medication. will be obtained from the central database of the patients' HMO.

    Six months after hospitalization

  • Change in blood level Cholesterol

    Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline from their medical files and at the follow-up patients will be invited again for blood tests.

    six mounths

  • Change in body mass index

    Change in body mass index:Patients' BMI will be measured at baseline and Patients will be asked to weigh in again at the six-month follow-up

    six-month

  • Smoking cessation

    Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.

    six months

  • Change in blood level Cholesterol

    Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline and at the follow-up from their medical files.

    six mounths

Secondary Outcomes (2)

  • Patients' and spouses' depression and anxiety symptoms

    Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time

  • Patients' and spouses' marital satisfaction

    Case group- the instruments will be administered twice: at baseline and at the six- month follow-up Control group- the instruments will be administered at a one point of time

Study Arms (2)

Couples coping with CHD

The target group will be 127 male patients and their partners. The couples will be recruited during the patients' first hospitalization for ACS. The participants will complete questionnaires during the hospitalization and again six months later. The patients will also be asked to be weighed and have their blood drawn and at the six-month follow-up for measurement of blood Cholesterol level. Relevant data will be obtained from their medical files.

control group

The control group will be 100 couples who are not coping with a life threatening illness. The couples will complete self report questionnaires at one point of time.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Paitents hospitalized Meir Medical Center Cardiac Care Unite

You may qualify if:

  • Jewish men with a Clinical diagnosis of first Acute Coronary Syndrome (ACS: myocardial infarction (MI) or unstable angina (UA))
  • Partners also agree to participate in the study

You may not qualify if:

  • a history of a previous cardiac event
  • a diagnosis other than ACS
  • co-morbid conditions (such as a severe psychiatric illness, end state renal disease or severe cancer)
  • absence of a spouse
  • inability to be interviewed in Hebrew

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Morris Mosseri, Professor

    Department of Cardiology, Meir Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morris Mosseri, Professor

CONTACT

972-9-7472587Morris.Mosseri@clalit.org.il

Noa Vilchinsky, Ph.D

CONTACT

972-3-531-8601noav18@inter.net.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

March 15, 2011

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

IL(1)