Nurse-Led Telehealth Frailty Management in Older Adults
2026年7月24日 更新者：Kutahya Health Sciences University
The Effect of a Nurse-Led Telehealth-Supported Multicomponent Frailty Management Program on Frailty and Functional Status in Older Adults Living at Home: A Randomized Controlled Trial
Frailty is an important geriatric syndrome associated with reduced physiological reserve, functional decline, falls, hospitalization, and increased health care use among older adults. This randomized controlled trial aims to evaluate the effect of a nurse-led telehealth-supported multicomponent frailty management program on frailty level and functional status in older adults living at home.
The study will be conducted as a single-center, two-arm, parallel-group randomized controlled trial. A total of 100 older adults aged 65 years and older who are living at home and are frail or at risk of frailty will be randomly assigned to either the intervention group or the control group in a 1:1 ratio.
Participants in the intervention group will receive an 6-week nurse-led telehealth-supported frailty management program, including weekly telephone counseling and individualized follow-up. Participants in the control group will continue usual care. Data will be collected at baseline, at 6 weeks, and at 18 weeks. The primary outcome is frailty level measured using the FRAIL Scale. Secondary outcomes include functional status, depressive symptoms, number of falls, emergency department visits, and hospitalizations.
調査の概要
詳細な説明
The intervention includes frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors.
The program will be delivered by a nurse through an initial face-to-face assessment and weekly telephone counseling sessions lasting approximately 20 to 25 minutes over 6 weeks.
Intervention fidelity will be monitored using a standardized checklist.
研究の種類
介入
入学 (推定)
100
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：Serkan Budak, PhD / RN
- 電話番号：+905385430616
- メール：serkan.budak@ksbu.edu.tr
研究場所
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Kütahya
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Simav、Kütahya、トルコ（Türkiye）、43500
- 募集
- Simav Doc. Dr. Ismail Karakuyu State Hospital Home Care Unit
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コンタクト：
- Serkan Budak, PhD / RN
- 電話番号：+905385430616
- メール：serkan.budak@ksbu.edu.tr
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-
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:
- Aged 65 years or older
- Living at home and not receiving institutional care
- Frail or at risk of frailty
- Having sufficient hearing and cognitive ability to communicate by telephone
- Able to read, understand, and communicate in Turkish
- Providing written informed consent
Exclusion Criteria:
- Having advanced cognitive impairment such as dementia
- Having hearing or speech problems that prevent communication
- Being bedridden
- Being in the terminal stage of illness
- Participating in another intervention or education program at the same time
- Having a serious physical or psychiatric condition that may prevent regular participation in the intervention
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 |
|---|---|
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実験的：Nurse-Led Telehealth-Supported Frailty Management Program
Participants in this arm will receive an 6-week nurse-led telehealth-supported multicomponent frailty management program in addition to usual care.
The program includes an initial face-to-face assessment and weekly telephone counseling sessions focused on frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors.
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The intervention is a structured 6-week multicomponent program delivered by a nurse.
Following baseline assessment and individualized goal setting, participants will receive weekly telephone counseling sessions lasting approximately 20 to 25 minutes.
The intervention covers frailty awareness, physical activity and mobility support, nutrition and fluid intake counseling, fall prevention and home safety, sleep and fatigue management, self-management, and healthy lifestyle behaviors.
Intervention fidelity will be monitored using a standardized checklist.
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介入なし：Usual Care
Participants in this arm will continue their routine daily life and usual health care services.
No structured frailty management intervention will be provided during the study period.
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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 |
|---|---|---|
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Frailty Level Assessed by the FRAIL Scale
時間枠：Baseline, 6 weeks, and 18 weeks
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Frailty level will be assessed using the FRAIL Scale.
The FRAIL Scale consists of five components: fatigue, resistance, ambulation, illnesses, and weight loss.
Total scores range from 0 to 5. Higher scores indicate greater frailty.
A score of 0 indicates robust status, scores of 1 to 2 indicate pre-frailty, and scores of 3 to 5 indicate frailty.
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Baseline, 6 weeks, and 18 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional Status Assessed by the Lawton-Brody Instrumental Activities of Daily Living Scale
時間枠：Baseline, 6 weeks, and 18 weeks
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Functional status will be assessed using the Lawton-Brody Instrumental Activities of Daily Living Scale.
Total scores range from 0 to 8. Higher scores indicate greater independence in instrumental activities of daily living.
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Baseline, 6 weeks, and 18 weeks
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Number of Falls During the Study Period
時間枠：From baseline to 18 weeks
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The number of falls experienced by participants during the study period will be recorded using a fall and health care utilization form developed by the researchers.
Data will be based on participant self-report.
A higher number indicates more falls.
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From baseline to 18 weeks
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Number of Emergency Department Visits During the Study Period
時間枠：From baseline to 18 weeks
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The number of emergency department visits during the study period will be recorded using a health care utilization form developed by the researchers.
Data will be based on participant self-report.
A higher number indicates greater emergency health care utilization.
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From baseline to 18 weeks
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Number of Hospitalizations During the Study Period
時間枠：From baseline to 18 weeks
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The number of hospitalizations during the study period will be recorded using a health care utilization form developed by the researchers.
Data will be based on participant self-report.
A higher number indicates greater hospital utilization.
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From baseline to 18 weeks
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Depressive Symptoms Assessed by the 15-Item Geriatric Depression Scale
時間枠：Baseline, 6 weeks, and 18 weeks
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Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale.
Total scores range from 0 to 15.
Higher scores indicate more severe depressive symptoms.
Scores of 0 to 4 indicate no depression, 5 to 8 indicate mild depression, 9 to 11 indicate moderate depression, and 12 to 15 indicate severe depression.
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Baseline, 6 weeks, and 18 weeks
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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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.
- Esfandiari E, Miller WC, Ashe MC. The Effect of Telehealth Interventions on Function and Quality of Life for Older Adults with Pre-Frailty or Frailty: A Systematic Review and Meta-Analysis. J Appl Gerontol. 2021 Nov;40(11):1649-1658. doi: 10.1177/0733464820983630. Epub 2021 Jan 6.
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)
2026年6月5日
一次修了 (推定)
2026年10月15日
研究の完了 (推定)
2026年10月15日
試験登録日
最初に提出
2026年6月4日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月8日
学習記録の更新
投稿された最後の更新 (実際)
2026年7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7月24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
- KSBU-FRAIL-RCT-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared because the study involves older adults and contains sensitive health-related information.
De-identified aggregate results may be reported in scientific publications.
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。