Couples Coping With Coronary Heart Disease (psychocardio)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01315834
First received: January 11, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

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.


Condition
Coronary Heart Disease (CHD)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Patients' medication adherence [ Time Frame: Six months after hospitalization ] [ Designated as safety issue: No ]
    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.

  • Change in blood level Cholesterol [ Time Frame: six mounths ] [ Designated as safety issue: No ]
    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.

  • Change in body mass index [ Time Frame: six-month ] [ Designated as safety issue: No ]
    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

  • Smoking cessation [ Time Frame: six months ] [ Designated as safety issue: No ]
    Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.

  • Change in blood level Cholesterol [ Time Frame: six mounths ] [ Designated as safety issue: No ]
    Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline and at the follow-up from their medical files.


Secondary Outcome Measures:
  • Patients' and spouses' depression and anxiety symptoms [ 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 ] [ Designated as safety issue: No ]
    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).

  • Patients' and spouses' marital satisfaction [ 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 ] [ Designated as safety issue: No ]
    Marital satisfaction - marital satisfaction will be measured using the EMS-ENRICH Marital Satisfaction Scale (Lavee, 1995(.


Estimated Enrollment: 130
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Paitents hospitalized Meir Medical Center Cardiac Care Unite

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315834

Contacts
Contact: Morris Mosseri, Professor 972-9-7472587 Morris.Mosseri@clalit.org.il
Contact: Noa Vilchinsky, Ph.D 972-3-531-8601 noav18@inter.net.il

Locations
Israel
Department of Cardiology, Meir Medical Center Recruiting
Kefar Saba, Israel
Contact: Morris Mosseri, Professor    972-9-7472587    Morris.Mosseri@clalit.org.il   
Contact: Noa Vilchinsky, Ph.D    972-3-531-8601    noav18@inter.net.il   
Principal Investigator: Morris Mosseri, Professor         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Morris Mosseri, Professor Department of Cardiology, Meir Medical Center, Israel
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01315834     History of Changes
Other Study ID Numbers: MMC10psycho-cardioCTIL
Study First Received: January 11, 2011
Last Updated: March 16, 2012
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014