Improving Sexual Function After Myocardial Infarction

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.

Conditions
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Sexual Function Disturbances, Myocardial Infarction

Intervention / Treatment
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* Other: Information film


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Information film<br>Randomized to receive a short information film online. | Other: Information film<br>* 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<br>|
| No Intervention: Standard care<br>No film, only questionnaire. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does specific sexual counselling improve sexual functioning in post-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 at 6 and 12 months after their MI. | 12 months | 
| Changes in sexual activity and functioning after MI | 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 | 
| Establish predictors of improved sexual functioning in post-MI patients | 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 |