Cardiac Implantable Electronic Device ImplantationNCT07857915
Educational Intervention for Elderly Patients With Cardiac Implantable Electronic Devices and Their Family Caregivers
A study testing Family-Centered Empowerment Model (FCEM) and Routine Care in people with Cardiac Implantable Electronic Device Implantation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This study evaluated whether a Family-Centered Empowerment Model could improve health status and functional independence and reduce complications in older adults after cardiac implantable electronic device (CIED) implantation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Implantable Electronic Device Implantation
- What is being tested?
- Family-Centered Empowerment Model (FCEM) and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- 26 Oct 2023to 26 Apr 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years Newly implanted or a candidate for cardiac implantable electronic device (CIED) implantation Discharged home and receiving continuous care from a primary family caregiver For family caregivers: basic literacy and ability to understand and apply the educational content
Who cannot join
- Inability to provide informed consent Absence of a primary family caregiver providing continuous care Inability of the participant or family caregiver to participate in the intervention or scheduled follow-up assessments Any condition preventing participation in the study or completion of the three-month follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Family-Centered Empowerment Model on Health Status, Functional Independence, and Post-Implantation Complications in Older Adults With Cardiac Implantable Electronic Devices
This study evaluated whether a Family-Centered Empowerment Model could improve health status and functional independence and reduce complications in older adults after cardiac implantable electronic device (CIED) implantation. Older adults and their primary family caregivers in the intervention group received structured education, problem-solving support, family participation, and follow-up in addition to routine care for three months. Participants in the control group received routine hospital education and usual care. Health status, functional independence, and post-implantation complications were assessed before the intervention and after three months.
- Being tested
- Family-Centered Empowerment Model (FCEM), Routine Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Centered Empowerment Model (FCEM)Other
A three-month Family-Centered Empowerment Model (FCEM) intervention delivered to older adults with newly implanted cardiac implantable electronic devices (CIEDs) and their primary family caregivers. The intervention consisted of six contacts approximately every two weeks, delivered through telephone follow-up, a messaging group, and face-to-face educational sessions. The intervention followed four stages: perceived threat, problem-solving, educational participation, and evaluation. It was provided in addition to routine hospital care and focused on strengthening patients' and family caregivers' participation in managing post-implantation care and related needs.
Routine CareOther
Participants received routine hospital care and standard education provided after cardiac implantable electronic device (CIED) implantation. A separate messaging group was available for participants to ask questions and receive routine follow-up support; however, no structured Family-Centered Empowerment Model intervention was provided.
| Study group | Role | What they receive |
|---|---|---|
| Family-Centered Empowerment Model (FCEM) | Experimental | Participants and their primary family caregivers received the Family-Centered Empowerment Model (FCEM) in addition to routine care for three months. The intervention consisted of six contacts approximately every two weeks, delivered through telephone follow-up, a messaging group, and face-to-face educational sessions. The FCEM included four stages: perceived threat, problem-solving, educational participation, and evaluation. Receives: Other: Family-Centered Empowerment Model (FCEM) |
| hospital's routine post-implantation education | Other | Participants received routine hospital education and usual care. A separate messaging group was available for questions and follow-up, but no structured Family-Centered Empowerment Model intervention was provided. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health status
Health status was assessed using the EQ-5D-3L questionnaire.
Measured: Baseline and 3 months after CIED implantation.
Secondary outcomes (1)
Functional independence
Functional independence was assessed using the Barthel Index.
Measured: Baseline and 3 months after CIED implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start26 Oct 2023
- Primary completion26 Jan 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Implantable Electronic Device ImplantationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sogand Sarmadi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857915
- Sponsor's protocol ID
- IR.SBMU.PHARMACY.REC.1402.120
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Family-Centered Empowerment Model on Health Status, Functional Independence, and Post-Implantation Complications in Older Adults With Cardiac Implantable Electronic Devices
- ClinicalTrials.gov ID
- NCT07857915
- Acronym / sponsor ID
- IR.SBMU.PHARMACY.REC.1402.120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 5 Oct 2026 (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.
This study evaluated whether a Family-Centered Empowerment Model could improve health status and functional independence and reduce complications in older adults after cardiac implantable electronic device (CIED) implantation. Older adults and their primary family caregivers in the intervention group received structured education, problem-solving support, family participation, and follow-up in addition to routine care for three months. Participants in the control group received routine hospital education and usual care. Health status, functional independence, and post-implantation complications were assessed before the intervention and after three months.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-Centered Empowerment Model (FCEM) | Experimental | Other: Family-Centered Empowerment Model (FCEM)Participants and their primary family caregivers received the Family-Centered Empowerment Model (FCEM) in addition to routine care for three months. The intervention consisted of six contacts approximately every two weeks, delivered through telephone follow-up, a messaging group, and face-to-face educational sessions. The FCEM included four stages: perceived threat, problem-solving, educational participation, and evaluation. |
| hospital's routine post-implantation education | Other | Other: Routine CareParticipants received routine hospital education and usual care. A separate messaging group was available for questions and follow-up, but no structured Family-Centered Empowerment Model intervention was provided. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥60 years Newly implanted or a candidate for cardiac implantable electronic device (CIED) implantation Discharged home and receiving continuous care from a primary family caregiver For family caregivers: basic literacy and ability to understand and apply the educational content
Key exclusion criteria (1 listed)
- Inability to provide informed consent Absence of a primary family caregiver providing continuous care Inability of the participant or family caregiver to participate in the intervention or scheduled follow-up assessments Any condition preventing participation in the study or completion of the three-month follow-up
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 |
|---|---|---|
| Family-Centered Empowerment Model (FCEM)A three-month Family-Centered Empowerment Model (FCEM) intervention delivered to older adults with newly implanted cardiac implantable electronic devices (CIEDs) and their primary family caregivers. The intervention consisted of six contacts approximately every two weeks, delivered through telephone follow-up, a messaging group, and face-to-face educational sessions. The intervention followed four stages: perceived threat, problem-solving, educational participation, and evaluation. It was provided in addition to routine hospital care and focused on strengthening patients' and family caregivers' participation in managing post-implantation care and related needs. | Other | Family-Centered Empowerment Model (FCEM) |
| Routine CareParticipants received routine hospital care and standard education provided after cardiac implantable electronic device (CIED) implantation. A separate messaging group was available for participants to ask questions and receive routine follow-up support; however, no structured Family-Centered Empowerment Model intervention was provided. | Other | hospital's routine post-implantation education |
Primary outcome
Health status
Time frame: Baseline and 3 months after CIED implantation.
Health status was assessed using the EQ-5D-3L questionnaire.
1 secondary outcome
Functional independence
Time frame: Baseline and 3 months after CIED implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-Centered Empowerment Model (FCEM) and Routine Care in people with Cardiac Implantable Electronic Device Implantation, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Oct 2026. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health status (time frame: Baseline and 3 months after CIED implantation.). 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 14 Oct 2026.