Improving Sexual Function After Myocardial Infarction
Sex/MI
1 other identifier
interventional
1,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 16, 2022
March 1, 2022
12 months
March 11, 2022
November 11, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Information film
ACTIVE COMPARATORRandomized to receive a short information film online.
Standard care
NO INTERVENTIONNo film, only questionnaire.
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Men and women ≥18 years old
- Acute MI during the last 6 weeks
- Informed consent for participation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sorlandet Hospital HFlead
- Oslo University Hospitalcollaborator
Study Sites (1)
Www.Sefh.No
Arendal, Norway
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frode Gallefoss
Sorlandets hospital HF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2022
First Posted
April 5, 2022
Study Start
November 7, 2022
Primary Completion
November 1, 2023
Study Completion
November 1, 2024
Last Updated
November 16, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share