An interventional study of Usual Orthopedic Care Guidance and Follow-up and Family-Centered Empowerment Model-Based Caregiver Intervention in Caregiver Burden and Hip Fractures, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Supportive care
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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.
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.
502 studies on the registry are indexed under Caregiver Burden; 165 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 403 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 96 studies on the registry; 82 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Usual Orthopedic Care Guidance and Follow-up
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.
Behavioral: Usual Orthopedic Care Guidance and Follow-up · Behavioral: Family-Centered Empowerment Model-Based Caregiver Intervention
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.
Caregiver Burden Measured by the Zarit Burden Interview (ZBI)
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.
Time frame: aseline, Periprocedural, 1 month, 3 months
No study locations are listed for this record.
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 284 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 293 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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The Fourth Affiliated Hospital of Zhejiang University School of Medicine