Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Kangli zhu
  • Número de teléfono: +8618258864804
  • Correo electrónico: 504053447@qq.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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:

-

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Caregiver Burden Measured by the Zarit Burden Interview (ZBI)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

5 de noviembre de 2026

Finalización primaria (Estimado)

5 de mayo de 2027

Finalización del estudio (Estimado)

5 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de noviembre de 2026

Publicado por primera vez (Actual)

13 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • KY-2026-113

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .