Improving Sexual Function After Myocardial Infarction (Sex/MI)
Primary Purpose
Sexual Function Disturbances, Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Information film
Sponsored by
About this trial
This is an interventional supportive care trial for Sexual Function Disturbances
Eligibility Criteria
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
Sites / Locations
- Www.Sefh.NoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Information film
Standard care
Arm Description
Randomized to receive a short information film online.
No film, only questionnaire.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05312320
First Posted
March 11, 2022
Last Updated
November 11, 2022
Sponsor
Sorlandet Hospital HF
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05312320
Brief Title
Improving Sexual Function After Myocardial Infarction
Acronym
Sex/MI
Official Title
Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF
Collaborators
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Function Disturbances, Myocardial Infarction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Information film
Arm Type
Active Comparator
Arm Description
Randomized to receive a short information film online.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
No film, only questionnaire.
Intervention Type
Other
Intervention Name(s)
Information film
Intervention Description
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
Primary Outcome Measure Information:
Title
Does specific sexual counselling improve sexual functioning in post-MI?
Description
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.
Time Frame
12 months
Title
Changes in sexual activity and functioning after MI
Description
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.
Time Frame
12 months
Title
Establish predictors of improved sexual functioning in post-MI patients
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke Salvesen, MD
Phone
+47 47304802
Email
vibeke.salvesen@sshf.no
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Johansen, Ph.D
Phone
+47 40496612
Email
nora.johansen@sshf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frode Gallefoss
Organizational Affiliation
Sorlandets hospital HF
Official's Role
Study Director
Facility Information:
Facility Name
Www.Sefh.No
City
Arendal
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vibeke Salvesen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://betami.org
Description
control group
Learn more about this trial
Improving Sexual Function After Myocardial Infarction
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