A Care Model for Elderly Hip-fractured Persons With Cognitive Impairment and Their Family Caregivers

NCT03894709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2020-09-04

No results posted yet for this study

Summary

This study aims to develop and examine an innovative family-centered intervention model for managing cognitive decline, improving postoperative recovery of hip-fractured patients with cognitive impairment, and enhancing family caregivers' competence in dementia care. This care model is theoretically underpinned by: (a) the Progressively Lowered Stress Threshold Model, a component of Lawton's ecological model of aging, and (b) the concept of partnership with family caregivers to strengthen their competence in providing care. Training are provided to family caregivers to enhance their competence in caring for hip-fractured patients with cognitive impairment. The effectiveness of the care model has been evaluated in a randomized controlled trial. The study was approved by the Institutional Review Board of Chang Gung Memorial Hospital. A protocol of the family-centered care model was developed, and the research nurses were trained to provide the interventions. A checklist, consisting of postoperative care, rehabilitation exercises, nutritional health teaching, environmental modification suggestions, delirium care, and care issues for elders with cognitive impairment, as well as management of behavioral problems, was also developed and are recorded by the research nurses. This report is based on data collected from 149 dyads of participants who were recruited by September 2018 and randomly assigned to either an experimental group (n=73) or a control group (n=76). No significant differences are found between experimental and control group in their demographic and clinical variables including age, gender, diagnosis, surgery type, the length of hospital stay, the cognitive functioning, marital status, and educational level, as well as the age and gender of family caregivers. The refusal rate this year is 73.6%. The main reasons for caregivers not participating are not needed and too busy or afraid of being interrupted. No significant differences are found in demographic variables (ie, age, gender, diagnosis, surgery method, and length of hospital stay) between those who participated and those who refused. Causes of the attrition includes that participants refused to participate any more (n=25), died (n=12), moved to another location (n=6), and loss of contact (n=3). Older persons who quit participating in the study are more younger (p=.021) and more are diagnosed with inter-/sub-trochanteric fracture (p=.015) as well as more are receiving internal fixation (p=.029). Outcome variables including patients' cognitive function, clinical measures, self-care ability, family caregivers' competence and preparedness, health service utilization, quality of life, and cost of care. In addition to the clinical effectiveness of the family-centered care model will be evaluated by hierarchical linear models at the end of this study.

Conditions

Interventions

BEHAVIORAL

family-centered care model

Teaching and training family caregivers to enhancing their skills for providing care for hip-fractured older persons The content of teaching material provided including management of wound, nutritional and balanced diet, rehabilitation exercises, home environment and behavioral problems after a hip surgery

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER
  • Chang Gung University

    collaborator OTHER
  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yea-Ing L. Shyu, PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03894709 on ClinicalTrials.gov