Telephone Calls for Health for Homebound Older Adults
2021年3月26日 更新者：Maninder Kahlon、University of Texas at Austin
A randomized controlled trial of the effect of 4 weeks of regular check-in calls, up to 5 per week based on participant's choice and 2 survey collection calls and possible referral of other services, versus no daily check-in calls, on self-reported loneliness measures for current Meals on Wheels participants (MOW).
調査の概要
詳細な説明
The intervention arm will include 125 MOW clients to receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them. After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.
Brief guidance and training will be provided for the daily conversation to maximize time spent speaking by the recipient but otherwise, the calls are unscripted other than specific prompts to ask about the recipient's general sense of well-being. "How are you doing today?"
The control Arm will include 125 MOW clients who will be randomized to a control group that will not receive the intervention calls. The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.
研究の種類
介入
入学 (実際)
240
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。
研究場所
-
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Texas
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Austin、Texas、アメリカ、78712
- University of Texas at Austin
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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
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adult (18+) clients of Meals on Wheels of Central Texas
Exclusion Criteria:
- Cognitive impairment or in a hospice program.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Intervention - Calls
Participants randomized to the intervention will receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them.
After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.
|
Calls were made by volunteers trained to engage with participants.
Call structure was unscripted and call length was recommended to be between 5-10 min.
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介入なし：Control - No calls
Participants randomized to a control group will not receive the intervention calls.
The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.
|
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 |
|---|---|---|
|
Loneliness as assessed by the De Jong Gierveld Loneliness Scale
時間枠：4 weeks
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Investigators will use the De Jong Gierveld Loneliness 6-Item Scale for Overall, Emotional, and Social Loneliness.
Scored from 0-6, a score of 0 indicates least lonely while a score of 6 indicates most lonely.
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4 weeks
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Loneliness as Assessed by the UCLA Short Scale for Measuring Loneliness in Large Surveys
時間枠：4 weeks
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Investigators will use the UCLA Short Scale for Measuring Loneliness in Large Surveys to measure loneliness.
Scored from 3-9, higher scores indicate greater degrees of loneliness.
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4 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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Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)
時間枠：4 weeks
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Investigators will use the Depression Patient Health Questionnaire (PHQ-8) to measure depression.
Scored from 0-3, and a score of 0 indicates lower levels of depression while a score of 3 indicates higher levels of depression.
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4 weeks
|
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Anxiety as Assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
時間枠：4 weeks
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Investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to measure anxiety.
Scored from 0-3, and a score of 0 indicates lower levels of anxiety while a score of 3 indicates higher levels of anxiety.
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4 weeks
|
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Health Status and Quality of Life as Assessed by the Short Form-12 Question Survey
時間枠：4 weeks
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Investigators will use the Short Form-12 question survey to measure physical and mental health status.
Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.
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4 weeks
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Social Engagement as Assess by the Short Lubben Social Network Scale (LSNS)
時間枠：4 weeks
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Investigators will use the 6-item Short Lubben Social Network Scale to measure social engagement.
For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.
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4 weeks
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Empathy as Assessed by The Consultation and Relational Empathy (CARE) Measure
時間枠：After the 4 week intervention (follow-up)
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Investigators will use the CARE Measure to evaluate measures of empathy in the context of the caller/participant relationship
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After the 4 week intervention (follow-up)
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Toronto Empathy Questionnaire
時間枠：Prior to the 4 week intervention (baseline)
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The Toronto Empathy Questionnaire will be used to assess characteristics of callers that align with measures of ability to be empathetic.
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Prior to the 4 week intervention (baseline)
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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
- Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.
- Anderson, G., Thayer, C. . Loneliness and Social Connections: A National Survey of Adults 45 and Older. Washington, DC: AARP Research, September 2018. https://doi.org/10.26419/res.00246.001.
- Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.
- Steger MF, Kashdan TB. Depression and Everyday Social Activity, Belonging, and Well-Being. J Couns Psychol. 2009 Apr;56(2):289-300. doi: 10.1037/a0015416.
- Derksen F, Bensing J, Lagro-Janssen A. Effectiveness of empathy in general practice: a systematic review. Br J Gen Pract. 2013 Jan;63(606):e76-84. doi: 10.3399/bjgp13X660814.
- Kahlon MK, Aksan N, Aubrey R, Clark N, Cowley-Morillo M, Jacobs EA, Mundhenk R, Sebastian KR, Tomlinson S. Effect of Layperson-Delivered, Empathy-Focused Program of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):616-622. doi: 10.1001/jamapsychiatry.2021.0113.
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)
2020年7月6日
一次修了 (実際)
2020年9月24日
研究の完了 (実際)
2020年9月26日
試験登録日
最初に提出
2020年10月14日
QC基準を満たした最初の提出物
2020年10月14日
最初の投稿 (実際)
2020年10月20日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月30日
QC基準を満たした最後の更新が送信されました
2021年3月26日
最終確認日
2021年3月1日
詳しくは
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。
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