Clinical trial NCT01315834: Couples Coping With Coronary Heart Disease
Official title: The Contribution of Personality Traits to Marital Satisfaction, Well Being and Physical Health in Couples Coping With Coronary Heart Disease Versus a Control Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease (CHD)
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-03-15
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paitents hospitalized Meir Medical Center Cardiac Care Unite

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Patients' medication adherence
timeFrame: Six months after hospitalization
measure: Change in blood level Cholesterol
timeFrame: six mounths
measure: Change in body mass index
timeFrame: six-month
measure: Smoking cessation
timeFrame: six months
measure: Change in blood level Cholesterol
timeFrame: six mounths
Secondary outcomes:
measure: Patients' and spouses' depression and anxiety symptoms
timeFrame: 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
measure: Patients' and spouses' marital satisfaction
timeFrame: 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
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Department of Cardiology, Meir Medical Center
Study officials:
affiliation: Department of Cardiology, Meir Medical Center, Israel
name: Morris Mosseri, Professor
role: PRINCIPAL_INVESTIGATOR
References: