テクノロジーベースの介入ユーザビリティとパイロットテスト (SIRENS)
認知症の患者の介護評価とサポートのためのプライマリケアのスクリーニングと介入：技術ベースの介入ユーザビリティとパイロット検査
This research project has three main goals:
(1) To create a new screening tool that helps primary care doctors spot signs of neglect in older adults with dementia. (2) To design a support program that can be delivered both in person and through a mobile app on Android phones. (3) To run a clinical trial with three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program-compared to standard care.
This current phase of the project focuses on parts of goals 1 and 2, as described below.
調査の概要
詳細な説明
Elder abuse is common and has serious health consequences but is under-recognized and under-reported. Older adults with dementia are at much higher risk of mistreatment than other older adults, and the risk of mistreatment has been shown to be greater with increasing severity of dementia. This mistreatment is usually perpetrated by caregivers.
Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. As few tools exist that may be effectively used in a busy clinical setting, evidence of the impact of screening and potential subsequent intervention on patient-important outcomes is lacking. Further, existing tools were developed for and studied in cognitively intact older adults and may not be appropriate for older adults with AD/ADRD.
In addition, elder mistreatment includes physical abuse, sexual abuse, verbal/emotional/psychological abuse, financial exploitation, and caregiver neglect. These different types of elder mistreatment represent very different phenomena, occur in various groups of older adults, and respond to very different intervention strategies. These discrepancies have made connecting positive identifications of mistreatment in the primary care setting to the next steps, including interventions, very challenging. Focusing on an intervention for caregiver neglect in older adults with dementia has the potential to address these challenges. Given that the severity of dementia represents a significant risk factor in the caregiving relationship, our goal is to provide support for dementia caregivers.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chelsie Burchett, PhD
- 電話番号：6469627141
- メール：cob2014@med.cornell.edu
研究連絡先のバックアップ
- 名前：Sophie Park
- メール：sep4008@med.cornell.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10065
- 募集
- Weill Cornell Medicine
-
コンタクト：
- Chelsie Burchett, PhD
- 電話番号：646-962-7141
- メール：cob2014@med.cornell.edu
-
主任研究者：
- Anthony Rosen, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Caregiver Inclusion Criteria
-
21 years old or older
-
Provides care for a patient of Weill Cornell Medicine/NewYork-Presbyterian who meets the following criteria: (pilot only)
- Patient is at least 60 years old
- Patient has diagnosed dementia
- Patient requires assistance with at least 1 ADL
-
Self-identifies as primary informal caregiver for an older adult
-
Provides 8 or more hours per week of direct care (may include logistics, oversight, observation, as well as hands-on care, but must include at least some in-person assistance)
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Can read and speak English at a 6th grade level or above
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Not blind or deaf
-
No active plan to disengage from providing care to the older adult within the next year
-
Ability to travel to the COA or CABR for study activities and/or attend study session(s) virtually through Zoom on their personal device
Caregiver Exclusion Criteria
- Non-fluent English speaker
- Hired caregiver
- Provides care for a patient in hospice care
- Too ill or weak to complete the interviews (per the interviewer)
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- 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: SIRENS Intervention
The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals. |
The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals. |
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 |
|---|---|---|
|
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by the Mean Difference in Score of the Program Evaluation Questionnaire.
時間枠：1 week post-intervention
|
System feasibility, acceptability and usability will be assessed in the Program Evaluation Questionnaire. This is based on the Davis Perceived Usefulness, Perceived Ease of Use, and User Acceptance Scale. Response options range from 1= Strongly Disagree to 7= Strongly agree. Questions include those asking about the technology and components of the intervention. Total scores range from 23 to 161. Higher scores indicate greater user acceptance of the technology. |
1 week post-intervention
|
|
Perceived system feasibility, acceptability, and usability of the SIRENS intervention as measured by a qualitative interview assessment
時間枠：1-week post intervention
|
System feasibility, acceptability and usability will be assessed in care partner participants using a semi-structured interview. Thematic analyses will be used to assess qualitative interviews. |
1-week post intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean difference in score of caregiver burden, as measured by the Zarit Caregiver Burden Assessment.
時間枠：Baseline and 1 week post-intervention
|
Caregiver burden will be assessed in care partner participants using the reliable and valid Zarit Caregiver Burden Assessment. Response options range from 0= Never to 4= Nearly always. Questions include those asking about relationship with the care recipient and stress. Overall scores range from 0 to 48, with higher scores indicating more caregiver burden. |
Baseline and 1 week post-intervention
|
|
Mean difference in score of caregiver quality of life, as measured by the Quality of Life Inventory
時間枠：Baseline and 1 week post-intervention
|
Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory. Questions include those asking about importance (on a 3-point rating scale, higher value indicating more importance) and satisfaction (on a 6-point rating scale, higher value indicating more satisfaction) of life domains. Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine the overall score. Overall scores range from -96 to 96, with higher scores indicating higher quality of life. |
Baseline and 1 week post-intervention
|
|
Mean difference in score of caregiver preparedness, as measured by the Caregiver Preparedness Scale
時間枠：Baseline and 1 week post-intervention
|
Caregiver preparedness will be assessed in care partner participants using the Preparedness Scale. Response options range from 0= Not at all prepared to 4= Very well prepared. Overall scores range from 0 to 24 with higher scores indicating more feelings of preparedness. |
Baseline and 1 week post-intervention
|
|
Mean difference in score of caregiving self-efficacy, as measured by the Caregiving Self-Efficacy Scale
時間枠：Baseline and 1 week post-intervention
|
Caregiving self-efficacy will be measured in care partner participants by a modified Caregiving Self-Efficacy Scale. Response options range from 0= Can not do at all to 100= Certainly can do. Overall scores range from 0 to 900 with higher scores indicating more confidence. |
Baseline and 1 week post-intervention
|
|
Mean difference in score of caregiver depression, as measured by the Center for Epidemiologic Studies Depression Scale
時間枠：Baseline and 1 week post-intervention
|
Caregiver depression will be assessed in care partner participants using the reliable and valid Center for Epidemiologic Studies Depression Scale. Response options range from 0= Rarely or none of the time to 3= Most or almost none of the time. Overall scores range from 0 to 60 with higher scores indicating greater depressive symptoms. |
Baseline and 1 week post-intervention
|
協力者と研究者
捜査官
- 主任研究者：Anthony Rosen, MD、Weill Cornell Medical College of Cornell University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 24-05027492
- R61AG079012 (米国 NIH グラント/契約)
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?
IPD プランの説明
The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich SIRENS database by the larger research community as this will further the impact of SIRENS and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
IPD 共有時間枠
The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
IPD 共有アクセス基準
The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of SIRENS, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by SIRENS investigators.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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
米国FDA規制機器製品の研究
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