Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

NCT06902636 | Recruiting DMC

• 2 other identifiers: KMUHIRB-F(I)-20230043NSTC113-2314-B-037-050-MY2-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.

Conditions

Limb Injury; Older Adults; Geriatric; Pain; Geriatric Depression; Barthel Index; Quality of Life; Loneliness

Keywords

Limb injury; geriatric trauma; older adults; loneliness

Outcome Measures

Primary Outcomes (5)

• Pain intensity

  Measured by the Numeric Pain Rating Scale with the numbers 0-10, with 0 meaning no pain and 10 meaning the worst pain.

  Day 1 at Hospital discharge, 1 month, and 3 months

• Functional disability

  The Barthel's Index consists of 30 items, ranging from 0 to 100, with higher scores indicating greater functional capacity.

  Day 1 at Hospital discharge, 1 month, and 3 months

• Depression

  The Geriatric Depression Scale Short Form, which comprises 15 items scored on a two-point scale (0 = no, 1 = yes). It scores ranged from 0-15 with the higher indicated the more severe depression symptoms.

  Day 1 at Hospital discharge, 1 month, and 3 months

• Loneliness

  The Elderly Loneliness Scale has eight items, with a higher score indicating more loneliness.

  Day 1 at Hospital discharge, 1 month, and 3 months

• Health-related quality of life

  The EuroQol-5D has five items with higher score indicated a worse health condition.

  Day 1 at Hospital discharge, 1 month, and 3 months

Study Arms (2)

Control group

NO INTERVENTION

The control group will have the routine care only

Geriatric Trauma Care Program

EXPERIMENTAL

The experiment group will implement the Geriatric Trauma Care Program (GTCP) and routine care. The GTCP will be implemented through an E-book that includes six units of intervention for older adults with traumatic injuries who live alone.

Behavioral: Geriatric trauma care program

Interventions

Geriatric trauma care program BEHAVIORAL

The experiment group will implement the Geriatric trauma care program (GTCP) and routine care. The GTCP will be implemented by a nurse practitioner and equipped with digitalized educational material, including six units of intervention for older adults with traumatic injuries who live alone.

Geriatric Trauma Care Program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• willing to join this study for three months
• with limb injuries
• living alone in a household
• aged 65 years old or older
• independent before a traumatic injury
• having a smartphone.

You may not qualify if:

• with an ISS greater than 16 (severe injuries)
• having cognitive impairments
• diagnosed with psychiatric illness

Sponsors & Collaborators

• Kaohsiung Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bih-O Lee, PhD

  College of Nursing, Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bih-O Lee, PhD

CONTACT

07-3121101; biholee@kmu.edu.tw

Santo Imanuel Tonapa, PhD

CONTACT

0981979212; i.santonapa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A randomized, double-blind, two-arm experimental design will be used.

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 30, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)