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COMPLETED
NCT07857915
NA

Educational Intervention for Elderly Patients With Cardiac Implantable Electronic Devices and Their Family Caregivers

Sponsor: Shahid Beheshti University of Medical Sciences

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-10-26

Completion Date

2024-04-26

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

OTHER

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

Routine Care

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.

Locations (1)

Imam Hossein Hospital

Tehran, Iran