Smart Care for Older Persons Recovering From Hip-fracture Surgery

NCT04675411 | Unknown

• 1 other identifier: NHRI 109-113
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study aims to examine the costs and effects of a Smart Care Model using smart clothing with alarm sensors that detect fall risks and monitor/give feedback on continuously recorded daily activity levels. This mixed-method study will include a quantitative component (a randomized control trial) and a qualitative component. Data will be collected and analyzed using an embedded type of mixed method, i.e., a small qualitative component will be embedded in a larger quantitative study. Before the study, we will seek institutional review board approval. The quantitative component, a randomized experimental design, will examine the effectiveness of the Smart Care Model. The control group will receive only usual care, and the experimental group will receive Smart Care. Subjects will be recruited from the trauma wards of Chang Gung Memorial Hospital (CGMH) at Linkou and New Taipei Tucheng hospital. The sample will include 158 subjects, with 79 in each group. Patients and caregivers in both groups will be assessed 8 times: at admission, before discharge, 1, 3, 6, 12, 18, and 24 months following hospital discharge. Outcomes will include (a) patient outcomes (clinical outcomes, self-care ability, adherence, service utilization, health-related quality of life \[HRQoL\] and cost of care), and (b) family caregiver outcomes (preparedness, perceived balance between competing needs, depressive symptoms and HRQoL). Analyses will follow an intention-to-treat principle. The effects of the Smart Care Model on health outcomes will be analyzed by hierarchical linear models. The qualitative component will follow the collection of quantitative data. A subset of 10 patients and their family caregivers will be chosen from participants who receive Smart Care, and 10 who receive routine care for in-depth personal interviews consisting of open-ended questions. Interviews will be transcribed verbatim and analyzed as suggested by Miles and Huberman (1994). After both quantitative and qualitative data are collected, the quantitative and qualitative results will be integrated, compared, and contrasted to fully explore the study aims.

Conditions

Hip Fractures

Keywords

smart care; hip fractures; home nursing; family caregiver

Outcome Measures

Primary Outcomes (16)

• muscle strength

  These outcomes will include muscle strength

  from 1 to 24 months following hospital discharge

• muscle endurance

  These outcomes will include muscle endurance

  from 1 to 24 months following hospital discharge

• flexibility

  These outcomes will include flexibility

  from 1 to 24 months following hospital discharge

• complications

  These outcomes will include complications

  from 1 to 24 months following hospital discharge

• mortality

  These outcomes will include mortality.

  from 1 to 24 months following hospital discharge

• Range of motion

  These outcomes will include ROM of affected limb

  from 1 to 24 months following hospital discharge

• pain intensity

  These outcomes will include pain

  from 1 to 24 months following hospital discharge

• IADL

  Self-care abilities will include performance of IADL.

  from 1 to 24 months following hospital discharge

• ADL

  Self-care abilities will include performance of ADLs.

  from 1 to 24 months following hospital discharge

• length of hospital stay

  Information on service utilization will include length of hospital stay (LOS)

  from 1 to 24 months following hospital discharge

• emergency department visits

  Information on service utilization will include emergency department visits

  from 1 to 24 months following hospital discharge

• hospital re-admission rate

  Information on service utilization will include hospital re-admission rate

  from 1 to 24 months following hospital discharge

• EQ5D

  HRQoL of hip-fractured older persons will be measured by the Taiwan-version five-dimension, three-level EuroQol questionnaire (EQ-5D-3L) for cost-effective analysis (Chang et al., 2007).

  from 1to 24 months following hospital discharge

• Health-related quality of life (HRQoL)

  HRQoL of hip-fractured older persons will be measured by the SF-36 Taiwan-version (Lu, Tseng, \& Tsai, 2003; Shyu, Chen, Liang, Lu et al., 2004; Tseng, Lu, \& Tsai, 2003).

  from 1to 24 months following hospital discharge

• Adherence

  We will measure the adherence to continuous rehabilitation. Family caregivers will be asked to keep a diary to record frequencies and types of daily rehabilitation performed by older persons as in our prior studies.

  from 1 to 24 months following hospital discharge

• Cost of care

  Cost-effectiveness of the SCM will be analyzed from the perspectives of the health care system and society. All health care costs will be derived from actual hospital information-system costs, the National Health Insurance claims database, patient self-reported out-of-pocket payments, and data from published and unpublished sources.

  from 1 to 24 following hospital discharge

Secondary Outcomes (4)

• Caregiver preparedness

  1, 3, 6, 12, 18, 24 months following hospital discharge

• Balance between competing needs

  1, 3, 6, 12, 18, 24 months following hospital discharge

• Caregiver depressive symptoms

  1, 3, 6, 12, 18, 24 months following hospital discharge

• Caregiver HRQoL

  1, 3, 6, 12, 18, 24 months following hospital discharge

Study Arms (2)

usual care

OTHER

After a fall leading to hip fracture, patients are cared for by orthopedists and receive internal fixation or arthroplasty. Consultations for internal medicine care are occasionally made depending on the patient's condition. During the first 1 to 2 days after surgery, nurses teach patients how to exercise while still in bed, using caution while changing their position. Pain-relief medications and antibiotics are also administered (for 2-3 days). The first day after surgery, physical therapy usually starts with rehabilitation training only on patients receiving arthroplasty. The average hospital stay is 5 to 7 days. After hospital discharge, very few patients use in-home or community rehabilitation or are admitted to a 2-week subacute rehabilitation unit. Patients usually come back to the clinic around 1, 3, 6, and 12 months after hospital discharge. However, adherence to this follow-up schedule is poor. Telephone follow-ups are seldom used.

Device: usual care

Smart Care Model

EXPERIMENTAL

The smart care model (SCM) will contain the components of geriatric assessment, continuous rehabilitation, and discharge planning. Sensors will be installed in bedrooms and living areas of the patient's home to receive signals from the smart clothing. Instant alerts and feedbacks from research nurses to family caregivers about the patient's condition and activity level will be provided.

Device: Smart care

Interventions

Smart care DEVICE

Home based nursing intervention with smart assisted technology

Also known as: usual care

Smart Care Model

usual care DEVICE

Routine hospital care with only in-hospital rehabilitation

usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years old
• admitted to CGMH from its emergency department due to one-side hip fracture,
• received hip arthroplasty or internal fixation
• can perform full range of motion against gravity and against some or full resistance
• pre-fracture Chinese Barthel Index (CBI) score \> 70
• living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).

You may not qualify if:

• severe cognitive impairment that makes them unable to follow orders (Chinese Mini-Mental State Examination score \<10)
• terminally ill
• without a primary family caregiver
• living in an institution.

Sponsors & Collaborators

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

Study Sites (2)

New Taipei Tucheng hospital

New Taipei City, 236017, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Yea-Ing L Shyu, PhD

CONTACT

032118800; yeaing@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and families will not be aware of their group enrollment and will be masked to the care model they receive. Research nurses who collect data will be independent of those who deliver the interventions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants in this trial will receive two care models: usual care and the Smart Care Model (SCM). The SCM will have two components: fall risk monitoring with an alarm, and activity-level monitoring with feedback. These SCM components are designed to enhance caregiver competence, decrease patient risk for subsequent falls, and improve postoperative recovery for hip-fractured patients with cognitive impairment (Table 2). We have integrated the technology of remote monitoring with smart clothing into continuous rehabilitation and discharge planning, along with geriatric consultation. We will compare the effects of the SCM and usual care in this trial.

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: December 19, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)