Improving Sexual Function After Myocardial Infarction (Sex/MI)
Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.
The study is completely digital. Men and women who recently had an MI will be invited through a written brochure that will be present in all Norwegian departments of cardiology. Post-MI patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. After consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group.
Control group: Standard surveillance after MI (no specific focus on sexual activity and functioning) Intervention group: Online sexual counselling including a short information film.
In order to assess the generalizability of the results, we will compare the age, sex and MI treatment of the respondents with data on Norwegian MI-patients in general.
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The investigators will invite the same number of women and men from the general population, invited through mass and social media.
All participants will be provided the same questionnaire at 4 weeks. Then outcome data will be obtained by a follow-up quest after 6 and 12 months.
The intervention is a film with the following main message:
- Sexual activity after MI does not increase risk of recurrence or death
- Sexual activity is associated with improved outcome after MI
- Resuming sexual activity as normal is recommended and completely safe
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vibeke Salvesen, MD
- Phone Number: +47 47304802
- Email: vibeke.salvesen@sshf.no
Study Contact Backup
- Name: Nora Johansen, Ph.D
- Phone Number: +47 40496612
- Email: nora.johansen@sshf.no
Study Locations
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Arendal, Norway
- Recruiting
- Www.Sefh.No
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Contact:
- Vibeke Salvesen, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women ≥18 years old
- Acute MI during the last 6 weeks
- Informed consent for participation
Exclusion Criteria:
- Lack of ability to cooperate
- Known alcohol- or drug-abuse, or use of narcotics
- Pregnancy or breast-feeding
- Serious comorbidity with a life expectancy <12 months
- Unstable or refractory angina
- Uncontrolled hypertension
- Congestive heart failure (NYHA class III/IV)
- High-risk arrhythmias
- Hypertrophic obstructive and other cardiomyopathies
- Severe valvular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Information film
Randomized to receive a short information film online.
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No Intervention: Standard care
No film, only questionnaire.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Does specific sexual counselling improve sexual functioning in post-MI?
Time Frame: 12 months
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The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants at 6 and 12 months after their MI.
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12 months
|
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Changes in sexual activity and functioning after MI
Time Frame: 12 months
|
The investigators will measure sexual activity and function at baseline, and 6 and 12 months after MI. The investigators will measure sexual function by Brief Sexual Function Inventory (BSFI) for male participants and Female Sexual Function Index (FSFI) for female participants. |
12 months
|
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Establish predictors of improved sexual functioning in post-MI patients
Time Frame: 12 months
|
In order to identify MI patients at risk of sexual dysfunction, the participants will answer questionnaires on quality of life (RAND-12), depression and anxiety (HADS), demographic data, comorbidity, medications and other factors that may have impact on sexual function.
|
12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Frode Gallefoss, Sorlandets hospital HF
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20/09003-10-521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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