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Sex/MI: Improving Sexual Function After Myocardial Infarction

Sponsor
Sorlandet Hospital HF (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05312320
Collaborator
Oslo University Hospital (Other)
1,200
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Information film
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Does specific sexual counselling improve sexual functioning in post-MI? [12 months]

    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.

  2. Changes in sexual activity and functioning after MI [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.

  3. Establish predictors of improved sexual functioning in post-MI patients [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Men and women ≥18 years old

  • Acute MI during the last four 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sorlandet Hospital HF
  • Oslo University Hospital

Investigators

  • Study Director: Frode Gallefoss, Sorlandets hospital HF

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT05312320
Other Study ID Numbers:
  • 20/09003-10-521
First Posted:
Apr 5, 2022
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myocardial Infarction
Infarction

Study Results

No Results Posted as of Apr 5, 2022