AzTrials
AzTrials

GeriatricsNCT07610161

Patient Experience of Older Adults Living Alone With Injuries

A study testing Geriatric Trauma Care Program in people with Geriatrics and Trauma Injury, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 74 years
Conditions the study is for
Geriatrics, Trauma Injury, Living Alone
What is being tested?
Geriatric Trauma Care Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
2 sitesTaiwan
Study dates
22 Nov 2023to 31 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 74 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan2 sites, 2 recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Kaohsiung, 807

    Bih-O BO Lee, Ph.D, 886-7-312-1101 ext 2625, biholee@kmu.edu.tw

    Recruiting
  • Kaohsiung Medical University

    Kaohsiung City

    Bih-O Lee, PHD, 886-7-312-1101 ext. 2625, biholee@kmu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
Geriatric Trauma Care Program
Medical subject headings
Accidental Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geriatric Trauma Care ProgramOther

    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".

Study groups in NCT07610161
Study groupRoleWhat they receive
experimental groupExperimentalResearchers will conduct the Geriatric Trauma Care Program for the experimental group.
Receives: Other: Geriatric Trauma Care Program
contrast groupNo interventionThe contrast group will be receiving the routine care only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Numeric Pain Rating Scale (NPRS)

    The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.

    Measured: at 1 day before hospital discharge

  2. The Barthel's Index (BI)

    The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.

    Measured: at 1 day before hospital discharge

  3. The Geriatric Depression Scale Short Form (GDS-SF)

    The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.

    Measured: at 1 day before hospital discharge

  4. The Elderly Loneliness Scale (ELS)

    Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.

    Measured: at 1 day before hospital discharge

  5. Taiwanese version of the EuroQol-5D (EQ-5D)

    The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.

    Measured: at 1 day before hospital discharge

  6. The Numeric Pain Rating Scale (NPRS)

    The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.

    Measured: at 1 months after hospital discharge

  7. The Barthel's Index (BI)

    The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.

    Measured: at 1 months after hospital discharge

  8. The Geriatric Depression Scale Short Form (GDS-SF)

    The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.

    Measured: at 1 months after hospital discharge

  9. The Elderly Loneliness Scale (ELS)

    Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.

    Measured: at 1 months after hospital discharge

  10. Taiwanese version of the EuroQol-5D (EQ-5D)

    The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.

    Measured: at 1 months after hospital discharge

  11. The Numeric Pain Rating Scale (NPRS)

    The NPRS is marked with the numbers 0-10 at equal intervals where 0 presents no pain and 10 illustrates the worst pain imaginable. Patients are required to rate the number that represents their current pain intensity. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.

    Measured: at 3 months after hospital discharge

  12. The Barthel's Index (BI)

    The BI will be used to measure functional disabilities. It is used to assess basic activities of daily living (BADL) in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. The Chinese version has been applied in older population, with Cronbach's alpha ranging from 0.79 to 0.85. The Cronbach's alpha will be retested in this study.

    Measured: at 3 months after hospital discharge

  13. The Geriatric Depression Scale Short Form (GDS-SF)

    The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.

    Measured: at 3 months after hospital discharge

  14. The Elderly Loneliness Scale (ELS)

    Loneliness has been defined as perceptions of being alone and separated from others. This concept has been conceptualized to measure desired social contacts and actual social contacts. Lin and Lin (2013) used 189 older adults to examine the Chinese ELS scale's reliability and validity. The ELS includes 3 items for social loneliness and 5 items for emotional loneliness. It has been scored by a 4 points Likert Scale from 1 to 4 with a higher score indicating more loneliness. The Cronbach's alpha for this will be retested in this study.

    Measured: at 3 months after hospital discharge

  15. Taiwanese version of the EuroQol-5D (EQ-5D)

    The EQ-5D is a scale used to measure the HRQoL developed in Europe, which has been globally tested and used. The EQ-5D has five dimensions including mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. A total of 15 items is included in the EQ-5D. Each dimension has three items assessed by three levels, never, moderate, and severe, of individual quality of life. A participant can only choose one of three levels of their quality of life. It indicates that an assessor only obtains 5 answers from each of 5 domains in the EQ-5D. The hospital discharge EQ-5D will be recalled by participants to report their HRQoL two weeks before admission. The Cronbach's alpha will be retested in this study.

    Measured: at 3 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start22 Nov 2023
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610161
Sponsor's protocol ID
KMUHIRB-F(I)-20230043
Status last verified
May 2026
First submitted
20 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Geriatric Trauma Care Program in people with Geriatrics and Trauma Injury, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bih-O Lee, PHD (886-7-312-1101 ext. 2625, biholee@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Numeric Pain Rating Scale (NPRS) (time frame: at 1 day before hospital discharge). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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