このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Patient Experience of Older Adults Living Alone With Injuries

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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

110

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Bih-O Lee, PHD
  • 電話番号:2625 886-7-312-1101
  • メールbiholee@kmu.edu.tw

研究場所

      • Kaohsiung City、台湾
        • 募集
        • Kaohsiung Medical University
        • コンタクト:
    • Kaohsiung
      • Kaohsiung City、Kaohsiung、台湾、807
        • 募集
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • コンタクト:
          • Bih-O BO Lee, Ph.D
          • 電話番号:886-7-312-1101 ext 2625
          • メールbiholee@kmu.edu.tw

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:experimental group
Researchers will conduct the Geriatric Trauma Care Program for the experimental group.
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".
介入なし:contrast group
The contrast group will be receiving the routine care only.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
The Numeric Pain Rating Scale (NPRS)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Bih-O Lee, PHD、Kaohsiung Medical University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年11月22日

一次修了 (推定)

2026年7月31日

研究の完了 (推定)

2026年10月31日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年5月20日

最初の投稿 (実際)

2026年5月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月27日

QC基準を満たした最後の更新が送信されました

2026年5月20日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • KMUHIRB-F(I)-20230043

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

外傷の臨床試験

Geriatric Trauma Care Programの臨床試験

購読する