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

NCT03894709 | Completed

• 1 other identifier: NHRI-EX107-10405PI
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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

Hip Fractures; Cognitive Impairment

Keywords

older persons; family-centered care model; family caregiver's competence; intervention protocol

Outcome Measures

Primary Outcomes (8)

• Change from baseline Total Range of Motion to one year

  Total range of motion of hip is measured using the sum of hip flexion and hip extension in degree.

  From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Muscle strength to one year

  Using physical examination to measure muscle strength of lower limbs in pond.

  From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Flexibility to one year

  Using physical examination to measure flexibility in centimeter (cm).

  From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Physical function to one year

  Physical function is measured using the performance of Activities of Daily Livings (ADLs). The performance of ADLs is assessed by the Chinese Barthel Index (CBI). The reliability and validity of the measure has been established (Chen, Dai, Yang, Wang, \& Teng, 1995) and supported in our prior studies (Shyu et al., 2005, 2008).

  From date of randomization until the date of discharge came first and then the progressions assessed up to 12 months

• Change from baseline Cognitive function to one year

  Cognitive function is measured using the MMSE Taiwan version. The 11-item MMSE Taiwan version assesses subjects' orientation, memory, common sense, ability to use language, ability to construct thoughts, as well as content of thought, form, and process (Folstein, Folstein, \& McHugh, 1975; Yip et al., 1992). Participants are categorized using MMSE at admission as cognitively impaired if \< 6 years of education and their MMSE score is \< 21, or if ≥ 6 years of education and their MMSE score is \< 25 (Yip et al., 1992). Acceptable reliability and validity were reported for the Taiwan version of MMSE.

  From date of randomization until the date of discharge came first and then the progressions assessed at 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Behavioral problems to one year

  Behavioral problems of hip-fractured patients with cognitive impairment are measured using the Chinese version Cohen-Mansfield Agitation Inventory (CMAI), community form. The Chinese version CMAI has been shown to be valid and reliable for a Taiwanese sample (Huang et al., 2013; Huang, Shyu, Chen, Chen, \& Lin, 2003). Each item is scored according to the frequency of the problem, ranging from 1 (never happens) to 7 (several times per hour). Cronbach's alpha for the Chinese version CMAI in patients with dementia was 0.83 (Huang et al., 2013).

  From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Caregiver competence to one year

  Caregiver competence are measured using the 17-item Chinese version Caregiver Competence Scale (Huang \& Shyu, 2003) developed from the original scale (Kosberg \& Cairl, 1991). This scale measures caregiver knowledge and skills for managing behavioral problems of patients with dementia. Items include whether the caregiver can search for related information in books and from health professionals, discuss patient behaviors with family members, provide an appropriate environment, assist and monitor medications, and handle patient's physical, emotional, and social needs. Items are scored from 1 (never) to 5 (always). Total scores range from 17 to 85; higher scores represent better competence. This scale had a content validity index of 0.89 and Cronbach's alphas of 0.75 - 0.90 in caregivers of patients with dementia (Huang \& Shyu, 2003; Huang et al., 2013).

  From date of randomization until the date of discharge came first and then progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

• Change from baseline Delirium to one year

  Patients are screened for delirium at the hospital following hip-fracture surgery using the Delirium Rating Scale, revision 98 (DRS-R-98), which was modified from the Delirium Rating scale (DRS). The DRS has 16 items, with 13 items measuring delirium severity and 3 diagnostic items. Scores for each severity item range from 0-3 and for each diagnostic item range from 0-2 or 0-3. Total scores from 0-7 are regarded as normal, 8-13 indicates pre-delirium, and \> 14 indicates delirium. The DRS was found to effectively differentiate delirium from cognitive disturbance caused by dementia, depression, or schizophrenic disorder (Franco, Trzepacz, MejÍa, \& Ochoa, 2009). The Taiwan version of the DRS-R-98 was found to have good validity and reliability (Huang et al., 2009)

  From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months

Secondary Outcomes (3)

• Change from one-month Service utilization to one year

  up to one year

• Change from baseline Health-related quality of life (HRQoL) to one year

  up to 12 months

• Change from baseline Cost of care to one year

  up to 12 months

Other Outcomes (3)

• Change from baseline Nutritional status to one year

  up to 12 months

• Change from baseline Depressive symptoms to one year

  up to 12 months

• Change from baseline Social support to one year

  up to 12 months

Study Arms (2)

The family-centered care model

EXPERIMENTAL

Interventions include a family-centered approach to interdisciplinary care and a family caregiving-training component to enhance family caregivers' competence in providing post-operative care and handling behavioral problems of adults with cognitive impairment. The interdisciplinary care model consists of geriatric consultation, continuous rehabilitation, and discharge planning. The family-centered approach involves family caregivers using a structured guide to assess the condition of the hip-fractured patient with cognitive impairment. Habits, daily routines, preferences, behavioral problems and environmental safety and stimuli are explored. The strengths, weakness, and resources of the family are assessed. The behavioral problems and symptoms to target are identified. Both the research nurse and the caregiver will then collaborate on a tentative plan to minimize the behavioral problems.

Behavioral: family-centered care model

Usual care

NO INTERVENTION

During hospitalization, patients receive health teaching for exercise while still in bed. Physical therapy usually starts only for those who received arthroplasty of hip replacement. Physical therapists train patients to use a walker and get in/out of bed through consultation. Usually, patients are discharged from the hospital without home assessment, nor are in-home programs provided for rehabilitation or nursing care. The usual care does not involve interdisciplinary care protocols, continuity of care, or specific care for hip-fractured patients with cognitive impairment.

Interventions

family-centered care model BEHAVIORAL

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

The family-centered care model

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are:
• age 60 years or older,
• admitted to CGMH due to one-side hip fracture, and being diagnosed as needing surgery,
• assessed as having cognitive impairment by the Chinese Mini-Mental State Examination (CMMSE) (CMMSE score \< 21 with \< 6 years education, or CMMSE \< 25 with ≥ 6 years education; Yip et al., 1992),
• having a primary family caregiver,
• living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju province).
• Family caregivers:
• age 20 years or older,
• responsible for providing direct care to or supervising care received by the patient.

You may not qualify if:

• Subjects are
• cognitively intact by CMMSE,
• without a primary family caregiver,
• terminally ill,
• severe cognitive impairment such that they are completely unable to follow orders (CMMSE \< 10; Yip et al., 1992).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• Chang Gung University: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (3)

• Tseng MY, Liang J, Wu CC, Cheng HS, Chen CY, Lin YE, Weng CJ, Yu YH, Shyu YL. Influence of Nutritional Status on a Family-Centered Care Intervention for Older Adults with Cognitive Impairment following Hip-Fracture Surgery: Secondary Data Analysis of a Randomized Controlled Trial. J Nutr Health Aging. 2022;26(12):1047-1053. doi: 10.1007/s12603-022-1864-y.

  PMID: 36519767 DERIVED

• Kuo WY, Chen MC, Lin YC, Yan SF, Shyu YL. Trajectory of adherence to home rehabilitation among older adults with hip fractures and cognitive impairment. Geriatr Nurs. 2021 Nov-Dec;42(6):1569-1576. doi: 10.1016/j.gerinurse.2021.10.019. Epub 2021 Nov 8.

  PMID: 34763234 DERIVED

• Tseng MY, Yang CT, Liang J, Huang HL, Kuo LM, Wu CC, Cheng HS, Chen CY, Hsu YH, Lee PC, Shyu YL. A family care model for older persons with hip-fracture and cognitive impairment: A randomized controlled trial. Int J Nurs Stud. 2021 Aug;120:103995. doi: 10.1016/j.ijnurstu.2021.103995. Epub 2021 Jun 2.

  PMID: 34146844 DERIVED

MeSH Terms

Conditions

Hip Fractures; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yea-Ing L. Shyu, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be informed that there two groups of the study. They will be randomized and allocated to one group and the research assistant explains the study to you does not know which group you will be, nor does the outcome assessor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: To develop a family-centered care model which providing health teaching to family caregivers of hip-fractured older persons with cognitive impairment how to care including rehabilitation exercises, diet, and management of behavioral problems.

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: March 28, 2019
• Study Start: January 1, 2015
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)