Coronary Heart Disease (CHD)psychocardioNCT01315834
Couples Coping With Coronary Heart Disease
An observational study of Coronary Heart Disease (CHD), run by Meir Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease (CHD)
- How many people
- 130 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Paitents hospitalized Meir Medical Center Cardiac Care Unite
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Cardiology, Meir Medical Center
Kfar Saba
Morris Mosseri, Professor, 972-9-7472587, Morris.Mosseri@clalit.org.il
Noa Vilchinsky, Ph.D, 972-3-531-8601, noav18@inter.net.il
About this study
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
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.
- Conditions
- Coronary Heart Disease (CHD)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: six-month
Smoking cessation
Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.
Measured: 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.
Measured: six mounths
Secondary outcomes (2)
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).
Measured: 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
Marital satisfaction - marital satisfaction will be measured using the EMS-ENRICH Marital Satisfaction Scale (Lavee, 1995(.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morris Mosseri, Professor, Principal investigator, Department of Cardiology, Meir Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315834
- Sponsor's protocol ID
- MMC10psycho-cardioCTIL
- Acronym
- psychocardio
- Status last verified
- Mar 2012
- First submitted
- 11 Jan 2011
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01315834
- Acronym / sponsor ID
- psychocardio / MMC10psycho-cardioCTIL
- Conditions
- Coronary Heart Disease (CHD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paitents hospitalized Meir Medical Center Cardiac Care Unite
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients' medication adherence
Time frame: Six months after hospitalization
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
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
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
Smoking cessation:self-report measures of the patients'smoking cessation at follow-up.
Change in blood level Cholesterol
Time frame: six mounths
Change in blood level Cholesterol:Patients' blood level Cholesterol will be taken at baseline and at the follow-up from their medical files.
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morris Mosseri, Professor principal investigator
Department of Cardiology, Meir Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease (CHD), run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morris Mosseri, Professor (972-9-7472587, Morris.Mosseri@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' medication adherence (time frame: Six months after hospitalization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.