Patient Experience of Older Adults Living Alone With Injuries

NCT07610161 | Recruiting

• 1 other identifier: KMUHIRB-F(I)-20230043
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Geriatrics; Trauma Injury; Living Alone

Outcome Measures

Primary Outcomes (15)

• 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.

  at 1 day before hospital discharge

• 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.

  at 1 day before hospital discharge

• 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.

  at 1 day before hospital discharge

• 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.

  at 1 day before hospital discharge

• 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.

  at 1 day before hospital discharge

• 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.

  at 1 months after hospital discharge

• 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.

  at 1 months after hospital discharge

• 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.

  at 1 months after hospital discharge

• 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.

  at 1 months after hospital discharge

• 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.

  at 1 months after hospital discharge

• 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.

  at 3 months after hospital discharge

• 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.

  at 3 months after hospital discharge

• 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.

  at 3 months after hospital discharge

• 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.

  at 3 months after hospital discharge

• 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.

  at 3 months after hospital discharge

Study Arms (2)

experimental group

EXPERIMENTAL

Researchers will conduct the Geriatric Trauma Care Program for the experimental group.

Other: Geriatric Trauma Care Program

contrast group

NO INTERVENTION

The contrast group will be receiving the routine care only.

Interventions

Geriatric Trauma Care Program OTHER

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".

experimental group

Eligibility Criteria

• Age: 65 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (2)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Kaohsiung, 807, Taiwan

RECRUITING

Kaohsiung Medical University

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Bih-O Lee, PHD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bih-O Lee, PHD

CONTACT

886-7-312-1101; biholee@kmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: November 22, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

TW (2)