Sexual Function DisturbancesSex/MINCT05312320
Improving Sexual Function After Myocardial Infarction
A study testing Information film in people with Sexual Function Disturbances and Myocardial Infarction, run by Sorlandet Hospital HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Sexual Function Disturbances, Myocardial Infarction
- What is being tested?
- Information film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteNorway
- Study dates
- 7 Nov 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥18 years old
- Acute MI during the last 6 weeks
- Informed consent for participation
Who cannot join
- 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
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- Congestive heart failure (NYHA class III/IV)
- High-risk arrhythmias
- Hypertrophic obstructive and other cardiomyopathies
- Severe valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Information film
- Medical subject headings
- Sexual Dysfunctions, Psychological, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information filmOther
- 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 group | Role | What they receive |
|---|---|---|
| Information film | Active comparator | Randomized to receive a short information film online. Receives: Other: Information film |
| Standard care | No intervention | No film, only questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start7 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Frode Gallefoss, Study director, Sorlandets hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312320
- Sponsor's protocol ID
- 20/09003-10-521
- Acronym
- Sex/MI
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sexual Function After Myocardial Infarction - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05312320
- Acronym / sponsor ID
- Sex/MI / 20/09003-10-521
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information film | Active comparator | Other: Information filmRandomized to receive a short information film online. |
| Standard care | No intervention | –No film, only questionnaire. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women ≥18 years old
- Acute MI during the last 6 weeks
- Informed consent for participation
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Information film |
Primary outcome
Does specific sexual counselling improve sexual functioning in post-MI?
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- control groupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frode Gallefoss study director
Sorlandets hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information film in people with Sexual Function Disturbances and Myocardial Infarction, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vibeke Salvesen, MD (+47 47304802, vibeke.salvesen@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does specific sexual counselling improve sexual functioning in post-MI? (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.