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Patient Experience of Older Adults Living Alone With Injuries

20. května 2026 aktualizováno: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

110

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Bih-O Lee, PHD
  • Telefonní číslo: 2625 886-7-312-1101
  • E-mail: biholee@kmu.edu.tw

Studijní místa

  • Tchaj-wan
      • Kaohsiung City, Tchaj-wan
        • Nábor
        • Kaohsiung Medical University
        • Kontakt:
    • Kaohsiung
      • Kaohsiung City, Kaohsiung, Tchaj-wan, 807
        • Nábor
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Kontakt:
          • Bih-O BO Lee, Ph.D
          • Telefonní číslo: 886-7-312-1101 ext 2625
          • E-mail: biholee@kmu.edu.tw

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. willing to join this study for 12 weeks
  2. limb injuries,
  3. living alone without any family,
  4. 65 to 74 years old,
  5. independent before an injury,
  6. have a smart phone
  7. be able to communicate in Mandarin

Exclusion Criteria:

  1. with an ISS greater than 16 (severe injuries)
  2. severe cognitive impairment
  3. severe illness such as organ system insufficiency
  4. diagnosed with depression

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: experimental group
Researchers will conduct the Geriatric Trauma Care Program for the experimental group.
Jiný: 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".
Žádný zásah: contrast group
The contrast group will be receiving the routine care only.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The Numeric Pain Rating Scale (NPRS)
Časové okno: at 1 day before hospital discharge
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)
Časové okno: at 1 day before hospital discharge
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)
Časové okno: at 1 day before hospital discharge
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)
Časové okno: at 1 day before hospital discharge
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)
Časové okno: at 1 day before hospital discharge
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)
Časové okno: at 1 months after hospital discharge
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)
Časové okno: at 1 months after hospital discharge
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)
Časové okno: at 1 months after hospital discharge
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)
Časové okno: at 1 months after hospital discharge
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)
Časové okno: at 1 months after hospital discharge
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)
Časové okno: at 3 months after hospital discharge
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)
Časové okno: at 3 months after hospital discharge
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)
Časové okno: at 3 months after hospital discharge
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)
Časové okno: at 3 months after hospital discharge
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)
Časové okno: at 3 months after hospital discharge
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Bih-O Lee, PHD, Kaohsiung Medical University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. listopadu 2023

Primární dokončení (Odhadovaný)

31. července 2026

Dokončení studie (Odhadovaný)

31. října 2026

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

20. května 2026

První zveřejněno (Aktuální)

27. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

27. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KMUHIRB-F(I)-20230043

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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