Myocardial Infarction, Sexual Function Disturbances
Conditions
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.
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
Interventions
OTHERInformation 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
Sponsors
Oslo University Hospital
Sorlandet Hospital HF
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Norway
Contacts
Primary ContactVibeke Salvesen, MD
Backup ContactNora Johansen, Ph.D
Outcome results
None listed