NCT03352817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

November 17, 2017

Last Update Submit

May 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

A questionnaire and an information sheet are provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence.

Patients in cardiac rehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • \<18yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2017

First Posted

November 24, 2017

Study Start

June 1, 2017

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations