- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07936513
Application of the Family-Centered Empowerment Model in an Intervention to Reduce Burden Among Primary Caregivers of Patients With Hip Fracture
Caring for a family member after a hip fracture can place physical, emotional, social, and financial demands on the main caregiver. This study evaluates whether a support program based on the Family-Centered Empowerment Model can reduce caregiver burden compared with usual care. The program helps caregivers understand care needs, develop practical skills, build confidence, and involve other family members in caregiving.
The study plans to include 80 adult family caregivers of patients with hip fracture at one hospital in China, with 40 caregivers in each group. Group assignment depends on the enrollment period rather than chance. Caregivers enrolled during the earlier period receive usual orthopedic care guidance and follow-up. Those enrolled during the later period receive the same usual care plus the empowerment program, including education, practical skills training, family discussions, and support after discharge.
Caregivers complete questionnaires near the patient's hospital admission, at discharge, and at 1 and 3 months after discharge. The main outcome is caregiver burden, meaning the strain and difficulties associated with providing care. Other outcomes include confidence in managing challenges, self-esteem, and caregiving-related quality of life. Patient complications and hospital readmissions are also recorded. The study will assess whether adding the empowerment program improves these outcomes.
A tanulmány áttekintése
Állapot
Körülmények
Részletes leírás
Caring for a family member after a hip fracture can place physical, emotional, social, and financial demands on the main caregiver. This study evaluates whether a support program based on the Family-Centered Empowerment Model can reduce caregiver burden compared with usual care. The program helps caregivers understand care needs, develop practical skills, build confidence, and involve other family members in caregiving.
The study plans to include 80 adult family caregivers of patients with hip fracture at one hospital in China, with 40 caregivers in each group. Group assignment depends on the enrollment period rather than chance. Caregivers enrolled during the earlier period receive usual orthopedic care guidance and follow-up. Those enrolled during the later period receive the same usual care plus the empowerment program, including education, practical skills training, family discussions, and support after discharge.
Caregivers complete questionnaires near the patient's hospital admission, at discharge, and at 1 and 3 months after discharge. The main outcome is caregiver burden, meaning the strain and difficulties associated with providing care. Other outcomes include confidence in managing challenges, self-esteem, and caregiving-related quality of life. Patient complications and hospital readmissions are also recorded. The study will assess whether adding the empowerment program improves these outcomes.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Kangli zhu
- Telefonszám: +8618258864804
- E-mail: 504053447@qq.com
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion Criteria:
- Inclusion Criteria:
- A family member serving as the primary caregiver of a patient with hip fracture aged 18 years or older.
- Has provided care for at least 3 months and provides care for at least 8 hours per day.
- Receives no remuneration for caregiving.
- Able to read and communicate.
- Willing to participate in the study and provide informed consent.
Exclusion Criteria:
- A history of psychiatric illness.
- Clinically diagnosed visual or hearing impairment that cannot be corrected with glasses, hearing aids, or other usual assistive devices and prevents the caregiver from reading study materials, participating in group discussions, or receiving study instructions. Age-related presbyopia or mild hearing loss that can be adequately corrected with assistive devices does not constitute an exclusion criterion.
Exclusion Criteria:
-
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: Usual Orthopedic Care
Primary family caregivers of patients with hip fracture receive usual orthopedic care guidance and routine follow-up. This includes education on hip fracture and rehabilitation during hospital days 1-2, guidance on home caregiving before discharge, and weekly telephone or WeChat follow-up after discharge. Follow-up continues through 3 months after discharge. |
Usual orthopedic care guidance and follow-up are provided to primary family caregivers of patients with hip fracture from the patient's hospital admission through 3 months after discharge. The intervention includes education on hip fracture and basic rehabilitation during the first 1-2 days of hospitalization, guidance on home caregiving before discharge, and routine telephone or WeChat follow-up once weekly after discharge. Both the control and experimental groups receive this intervention. |
|
Kísérleti: Usual Care Plus Family-Centered Empowerment Model Intervention
Primary family caregivers receive usual orthopedic care guidance and follow-up plus a structured Family-Centered Empowerment Model intervention from admission through 3 months after discharge. The program includes: (1) within 24 hours of admission, a caregiving manual and a group discussion addressing perceived threat (about 30 minutes); (2) during hospital days 1-7, two individual hands-on caregiving skills and scenario-based simulation sessions to strengthen self-efficacy (about 40 minutes each); (3) from day 8 to discharge, two sessions involving family participation in care planning and sharing caregiving experiences to support self-esteem (about 30 minutes each); and (4) after discharge, five targeted follow-up contacts and two online caregiving experience-sharing sessions for process and outcome evaluation. |
Usual orthopedic care guidance and follow-up are provided to primary family caregivers of patients with hip fracture from the patient's hospital admission through 3 months after discharge. The intervention includes education on hip fracture and basic rehabilitation during the first 1-2 days of hospitalization, guidance on home caregiving before discharge, and routine telephone or WeChat follow-up once weekly after discharge. Both the control and experimental groups receive this intervention. Primary family caregivers of patients with hip fracture receive a four-stage Family-Centered Empowerment Model program in addition to usual care, from the patient's admission through 3 months after discharge: (1) perceived threat: a standardized caregiving manual and group discussion within 24 hours of admission (about 30 minutes); (2) self-efficacy: two individual hands-on caregiving skills and scenario-based simulation sessions during hospital days 1-7 (about 40 minutes each); (3) self-esteem: two sessions involving family participation in care planning and sharing caregiving experiences from day 8 to discharge (about 30 minutes each); and (4) process and outcome evaluation: five targeted follow-up contacts and two online caregiving experience-sharing sessions after discharge through 3 months. This program is provided only to the experimental group. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Caregiver Burden Measured by the Zarit Burden Interview (ZBI)
Időkeret: aseline, Periprocedural, 1 month, 3 months
|
Caregiver burden is assessed using the 22-item Zarit Burden Interview (ZBI). Each item is scored from 0 to 4, and item scores are summed to produce a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden. Total scores are assessed at baseline, hospital discharge, and 1 and 3 months after discharge. |
aseline, Periprocedural, 1 month, 3 months
|
Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Sebek és sérülések
- Viselkedési tünetek
- Lábsérülések
- Törések, csont
- Stressz, pszichológiai
- Combcsonttörések
- Csípősérülések
- Viselkedés
- A kezelés betartása és betartása
- Egészségügyi Viselkedés
- Beteg-megfelelőség
- Az egészségügyi ellátás betegek általi elfogadása
- Ragaszkodási beavatkozások
- Gyógyszertartás
- Gondozói teher
- Csípőtáji törések
- Egészségnevelés
Egyéb vizsgálati azonosító számok
- KY-2026-113
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
De-identified individual participant data underlying the published study results, together with a data dictionary, will be made available to qualified researchers upon reasonable request. Data access will require a written research proposal describing the intended analyses, review by the study team, and compliance with applicable institutional and ethics requirements. Any additional participant consent required for the proposed use will be obtained before sharing. Names, contact details, and other direct identifiers will not be shared.
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