Study of Sexual Dysfunction in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne (SexualDysf)

Study of Sexual Dysfunction and Place of Sexuality in Patients Included in a Cardiac Rehabilitation Program in Champagne-Ardenne

Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop. The investigators conducted an observational multicenter prospective study for descriptive and analytical purposes after approval by the Institutional review board. An anonymous questionnaire was distributed from June 1 to September 1, 2017 in patients participating in a cardiac rehabilitation program in the various centers in the region.

Study Overview

• Status: Completed
• Conditions: Patients With Heart Disease
• Intervention / Treatment: Other: Cardiac rehabilitation

Detailed Description

Sexual health is an important marker of individual quality of life and well-being of patients. Sexual dysfunction (SD) is common in patients with heart disease. Screening and management are recommended. Cardiac rehabilitation (CR) seems to be a privileged moment to address this problem, but the management is often insufficient. The main objective of the study was to evaluate the prevalence of SD in patients in CR in the Champagne-Ardenne region. Secondary objectives were to describe SD most frequently encountered, to identify risk factors of SD, to compare the feelings of patients about their sex life, before and after an acute cardiac event and to collect an estimate of the need for care by a dedicated sexology workshop.

This prospective multicentre study was carried out in the cardiac rehabilitation centers of Champagne-Ardenne (Reims, Ardennes and Troyes ) between 1 June and 1 September 2017 by anonymous self-questionnaire.

Eligible patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily. Sexual inactivity and celibacy were not exclusionary criteria because prior sexual behavior did not predict future behavior and the need for counseling. Patients were informed about the objectives and conduct of the study by a health professional during their rehabilitation program or in follow-up consultations with the cardiologist. If the patient agreed to participate in the study, a questionnaire and an information sheet was provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence. It was then put back in an enclosed opaque envelope, in a closed urn left near the cloakroom of each center.

Data are described as mean (± standard deviation) for quantitative variables and as a percentage for categorical variables. The Student or Wilcoxon-Mann Whitney test were used for the quantitative variables and chi-square or Fisher's exact test for categorical variables. The multivariate analysis of SD risk factors was performed by logistic regression. The Odds Ratio (OR) is reported with its 95% confidence interval (CI). The tests were bilateral with a threshold of significance at p <0.05.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Reims, France, 51092
    • CHU Reims

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily

Description

Inclusion Criteria:

• patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily

Exclusion Criteria:

• <18yo

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in cardiac rehabilitation; Eligible patients must have reached the age of majority, participate in a CR program at one of the centers cited, and agreed to respond to the study questionnaire voluntarily	Other: Cardiac rehabilitation; A questionnaire and an information sheet are provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of sexual dysfunction in cardiac rehabilitation	Specific key measurements or observations used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment	Day 0

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: PZ17040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No