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: Recruiting
• Conditions: Myocardial Infarction; Sexual Function Disturbances
• Intervention / Treatment: Other: Information film

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: Interventional
• Enrollment (Anticipated): 1200
• 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

• Norway
  • Arendal, Norway
    • Recruiting
    • Www.Sefh.No
    • Contact: Vibeke Salvesen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Information film; Randomized to receive a short information film online.	Other: Information film; 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
No Intervention: Standard care; No film, only questionnaire.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sorlandet Hospital HF
• Collaborators: Oslo University Hospital
• Investigators: Study Director: Frode Gallefoss, Sorlandets hospital HF

Publications and helpful links

Helpful Links

• control group

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 20/09003-10-521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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