CClinicalTrials.gg
Status unknownNCT01315834psychocardioUpdated Mar 19, 2012

Couples Coping With Coronary Heart Disease

An observational study in Coronary Heart Disease (CHD), sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2012-03-19.

Sponsored by Meir Medical Center · Observational

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
130
Sex
All
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Study 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.

Read the detailed description

Heart disease is the world's leading cause of death in most industrial countries and it requires drastic changes in the lifestyle of the patient. Research on social support and coping with stress has repeatedly shown that being in a supportive spousal relationship has a significant effect on the recovery from a heart disease through alterations in mood, as well as through health habits. However, there are interpersonal differences in the abilities to receive and to provide support. Most of the literature to date has focused either on the experiences of the support recipient or on the support provider; much less research has taken both partners' characteristics into consideration (Revenson \& DeLongis, 2011).

The current research aims to broaden the understanding of spousal support among couples coping with a life threatening illness- Coronary Heart Disease (CHD) versus general population of couples. Two studies were designed. Study 1(control group) will focus on general population of couples and its goal is examine the contribution of personality traits of the couples to their marital satisfaction and well-being. Study 2 (target group) will focus on couples coping with a first acute coronary heart disease and its goal is to examine the contribution of personality traits of the couples to their marital satisfaction and well-being, and to health promoting behaviors (smoking cessation, medication adherence) and physical recovery (change in body mass index, change in cholesterol levels) of the ill partners.

The proposed research is a prospective, longitudinal study. The control group will be 100 couples who are not coping with a life threatening illness. The couples will complete self report questionnaires. 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. Relevant data will be obtained from their medical files.

This study's findings could inform clinicians whose goal is to foster better patient-spouse dynamics in the context of major medical stressors. Helping couples master the challenge of providing and receiving support in such trying times may contribute to enhanced levels of adherence among patients which, in turn, would lead to improved health and saved lives.

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Conditions studied

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In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 130 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Paitents hospitalized Meir Medical Center Cardiac Care Unite

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
130 participants (estimated)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Six months after hospitalization

  2. 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.

    Time frame: six mounths

  3. 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

    Time frame: six-month

  4. Smoking cessation

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

    Time frame: six months

  5. 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.

    Time frame: six mounths

Secondary outcomes

  1. Patients' and spouses' depression and anxiety symptoms

    Depression and anxiety- depressive and anxiety symptoms will be measured using the Brief Symptom Inventory \[BSI;( Derogatis \& Melisaratos, 1983)\]. Each participant will be asked to rate the degree to which he has suffered from each symptom during the previous month on a scale ranging from 0 (not at all) to 4 (very much).

    Time frame: 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

  2. Patients' and spouses' marital satisfaction

    Marital satisfaction - marital satisfaction will be measured using the EMS-ENRICH Marital Satisfaction Scale (Lavee, 1995(.

    Time frame: 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

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Study locations

1 of 1 sites recruiting
  • Department of Cardiology, Meir Medical Center
    Kefar Saba, Israel
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01315834
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
Mar 15, 2011
Start date
Apr 2011
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Mar 19, 2012

Study contacts

Morris Mosseri, Professor
Contact
Morris.Mosseri@clalit.org.il
972-9-7472587
Noa Vilchinsky, Ph.D
Contact
noav18@inter.net.il
972-3-531-8601
Morris Mosseri, Professor
principal investigator · Department of Cardiology, Meir Medical Center, Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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