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Recruiting NCT07610161

Patient Experience of Older Adults Living Alone With Injuries

No phase Interventional Geriatrics Trauma Injury Living Alone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Geriatric Trauma Care Program.
Who it may be relevant to
Registry conditions: Geriatrics, Trauma Injury, Living Alone. Basic parameters: 65 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Patient Experience of Older Adults Living Alone With Injuries and Long-Term Effects of Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

Overview

This study aims to explore the patient experiences of living alone older adults with injuries, and to examine the effects of a "Geriatric Trauma Care Program" in older adults with limb injuries who live alone. A three-year design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage of this study, a two-arm experimental design will be used.

Detailed description

Aim: This study aims to explore patient experience of living alone older adults with injuries, and to examine effects of a "Geriatric Trauma Care Program (GTCP)" in older adults with limb injuries who live alone.

Design: A two-stage design will be used to reach the purposes of this study. The first stage of this study will use descriptive phenomenology to get patient experiences of living alone older adults with injuries. In the second stage, a two-arm experimental design will be used to intervene the "GTCP" and evaluate its outcomes.

Methods: In the first stage, the study settings will be surgical outpatient departments at a university hospital. Purposive sampling will be used to select old adult patients with injury and living alone. Semi-structured and audio-taped interviews will be used as data collection method. About 15 to 20 participants are planned to be interviewed. Colaizzi's (1978) methods will be applied to data analysis. The findings will be used to modify the intervention for the second stage in this study.

In the second stage, a two-arm experimental design will be used. The participants will be older adults with limb injuries. The experiment group will receive the "GTCP" and routine care, and the control group will receive routine care only. The GTCP includes a two-session intervention named "Digital geriatric trauma care" and "Multiple training modalities". The two sessions will use an "age-friendly e-Book" and a "personalized-oriented App" as assistant materials. A three-time point data collection will be used including at hospital discharge, 1 month and 3 months after hospital discharges. The pre -and post- intervention measures will be five structured scales including pain, functional disability, geriatric depression, loneliness, and quality of life. The 2nd stage expects to collect 45 participants in each group. The experimental effects will be examined by the generalized estimating equations (GEEs) model.

Interventions

  • Other Geriatric Trauma Care Program
    The intervention program named GTCP includes two sessions with two digital materials named "Digital geriatric trauma care" (DGTC) and "Multiple training modalities" (MTM). The DGTC has been establishing as an Age-friendly e-Book. It has six units. The MTM has three units including "handwritten wisdom quotes", "6-minute meditation", "inspirational words".

Primary outcome measures

  • The Numeric Pain Rating Scale (NPRS) [Time frame: at 1 day before hospital discharge]
  • The Barthel's Index (BI) [Time frame: at 1 day before hospital discharge]
  • The Geriatric Depression Scale Short Form (GDS-SF) [Time frame: at 1 day before hospital discharge]
  • The Elderly Loneliness Scale (ELS) [Time frame: at 1 day before hospital discharge]
  • Taiwanese version of the EuroQol-5D (EQ-5D) [Time frame: at 1 day before hospital discharge]
  • The Numeric Pain Rating Scale (NPRS) [Time frame: at 1 months after hospital discharge]
  • The Barthel's Index (BI) [Time frame: at 1 months after hospital discharge]
  • The Geriatric Depression Scale Short Form (GDS-SF) [Time frame: at 1 months after hospital discharge]
  • The Elderly Loneliness Scale (ELS) [Time frame: at 1 months after hospital discharge]
  • Taiwanese version of the EuroQol-5D (EQ-5D) [Time frame: at 1 months after hospital discharge]

Eligibility criteria

Inclusion criteria

  • willing to join this study for 12 weeks
  • limb injuries,
  • living alone without any family,
  • 65 to 74 years old,
  • independent before an injury,
  • have a smart phone
  • be able to communicate in Mandarin

Exclusion criteria

  • with an ISS greater than 16 (severe injuries)
  • severe cognitive impairment
  • severe illness such as organ system insufficiency
  • diagnosed with depression

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Taiwan · 2 centers
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
  • Kaohsiung Medical University — Kaohsiung City

Identifiers

NCT: NCT07610161 · KMUHIRB-F(I)-20230043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗