Couples Coping With Coronary Heart Disease

Coronary Heart Disease (CHD) Clinical Trial

— psychocardio  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315834
• Other study ID #: MMC10psycho-cardioCTIL
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2011
• Last updated: March 16, 2012
• Start date: April 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Morris Mosseri, Professor
• Phone: 972-9-7472587
• Email: Morris.Mosseri[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease (CHD)
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Department of Cardiology, Meir Medical Center	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Smoking cessation	Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.	six months	No
Primary	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	No
Secondary	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).	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	No
Secondary	Patients' and spouses' marital satisfaction	Marital satisfaction - marital satisfaction will be measured using the EMS-ENRICH Marital Satisfaction Scale (Lavee, 1995(.	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	No