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Smart Care for Older Persons Recovering From Hip-fracture Surgery

NCT04675411 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2023-08-30

No results posted yet for this study

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

Interventions

DEVICE

Smart care

Home based nursing intervention with smart assisted technology

DEVICE

usual care

Routine hospital care with only in-hospital rehabilitation

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • Chang Gung University

    collaborator OTHER

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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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 NCT04675411 on ClinicalTrials.gov