Supporting Family Caregivers With Technology for Dementia Home Care (FamTechCare)
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing challenging behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors in PWD that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Caregivers record care situations they select and upload videos to a secure site. The expert team will review intervention group videos weekly and will provide individualized feedback for improving care to caregivers in the home. The control group caregivers will receive a weekly phone call and advice from a nurse, but their recorded videos will be held for review and individualized feedback provided after 3 months.
Study aims are to use observation to assist caregivers in behavior management. Effects on disruptive behaviors and caregiver burden and other negative outcomes will be compared. Investigators will evaluate ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice. This is the first study to test new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
調査の概要
詳細な説明
This clinical trial will test the FamTechCare intervention that uses multidisciplinary professional guidance based on in-home video monitoring to support family caregivers in managing behaviors of persons with dementia (PWD). Families provide the majority of care for PWD at home. However the stress of caregiving is so significant that it increases caregiver morbidity and mortality. Stress is magnified by disruptive behaviors that frequently lead to nursing home placement. In-home video monitoring allows experts to assess behaviors of PWD and to identify antecedents, recommend specific interventions, and subsequently evaluate caregiver outcomes. FamTechCare uses new technology to link family caregivers to experts for guidance in managing disruptive behaviors, supporting continued care at home while reducing the negative effects of caregiving.
Caregiver-PWD dyads (N=88) will be randomly assigned to intervention or control groups. Both groups will record behaviors during daily care for 3 months using a home monitoring unit. Notably, this new technology captures 3-5 minutes prior to the behavior, thus recording behavior triggers and precursors. Intervention group videos will be auto-uploaded to a Health Insurance Portability and Accountability Act (HIPAA) secure Internet site for weekly team review with in-home feedback to caregivers in behavior management. The time and attention equivalent control group will receive a weekly phone call from a nurse, but their recorded videos will be held for review and feedback after 3 months.
Study aims are to identify interventions, based on in-home observations, to assist caregivers in behavior management. Between-group effects on outcomes, including PWD disruptive behaviors and caregiver burden and other negative outcomes will be compared using linear mixed modeling. Ease of use and satisfaction, cost-efficiency, and factors influencing likelihood of translation into practice will be evaluated. This tests new technology for direct observation and immediate feedback to empower families to manage PWD behaviors at home while reducing caregiver stress and morbidity. Technology links caregivers to individualized expert guidance, acknowledging the importance and burden of their role. This study addresses NIH missions and the 2012 National Plan to Address Alzheimer's disease goals, integrating strategies to promote adoption and use of aging services technologies in interventions that will reduce negative caregiver outcomes, a growing public health problem.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa College of Nursing
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
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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
Inclusion Criteria:
- Person caring for someone with a diagnosis of Alzheimer's disease or other dementia at home.
Exclusion Criteria:
- Exclusion criteria include Huntington's disease, alcohol-related dementia, schizophrenia, manic-depressive disorder, deafness, and mental retardation.
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
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実験的：Intervention FamTechCare
This group will submit videos and receive weekly feed back after review by dementia care experts for managing challenging care situations.
The intervention is weekly individualized feedback based on video data (FamTechCare).
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Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
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プラセボコンパレーター：Control and Delayed FamTechCare
This group will submit videos and will receive weekly feedback from a nurse based on their verbal communication until the end of their participation.
At the end of the study, they will receive feedback based on submitted videos from dementia care experts (delayed FamTechCare).
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Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
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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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Change in Behaviorally Coded Challenging Behaviors (Agitated, Disruptive, Resistive)
時間枠：3 months
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Behavioral coding of videos for agitated, disruptive, or resistive behaviors will be used to identity changes in behavior before and after the intervention.
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3 months
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Change in Caregiver Stress - Reaction to Memory Symptoms (Bother)
時間枠：Baseline, 1 month, 3 months
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Caregiver reaction to behavioral symptoms of the Person with Dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC).
The RMPBC contains 24 items, each with two parts.
Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present.
If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely).
If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32).
A higher score indicates a greater negative reaction to behaviors.
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Baseline, 1 month, 3 months
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Change in Caregiver Stress - Reaction to Depressive Symptoms (Bother)
時間枠：Baseline, 1 month, 3 months
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Caregiver reaction to behavioral symptoms of the person with dementia (PWD) was measured by the Revised Memory and Problem Behavior Checklist (RMPBC).
The RMPBC contains 24 items, each with two parts.
Each item represents a behavior; if the behavior has been exhibited by the PWD in the past week, the caregiver reports the behavior as present.
If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely).
If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32).
A higher score indicates a greater negative reaction to behaviors.
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Baseline, 1 month, 3 months
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Change in Caregiver Stress - Desire to Instituionalize
時間枠：Baseline, 1 month, 3 months
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Desire to institutionalize was measured using a modified Desire to Institutionalize Scale.
The modified Desire to Institutionalize Scale contains six items rated as dichotomous yes or no (1 = yes; 0 = no).
A higher score indicates a greater desire to institutionalize (range = 0-6).
Internal consistency for the Desire to Institutionalize scale is adequate (α = .69-.77) and has shown adequate construct validity through factor analysis.
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Baseline, 1 month, 3 months
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Change in Caregiver Stress - Biological Sensor Data
時間枠：Baseline, 1 month, 3 months
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Biological stress reactions measured by sensor
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Baseline, 1 month, 3 months
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Change in Caregiver Burden
時間枠：Baseline, 1 month, 3 months
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Caregiver burden was measured using the Modified Zarit Burden Scale that contains 12 items with a 5-point Likert scale (0 = never; 4 = nearly always) adapted from the 22-item Zarit Burden Interview.
A higher score indicates greater caregiver burden (range = 0-48).
The Modified Zarit Burden Scale has shown adequate internal consistency (α = .88)
and excellent concurrent validity (r = .92-
.97)
with the full Zarit Burden Interview.
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Baseline, 1 month, 3 months
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Change in Caregiver Health and Wellbeing - Depression
時間枠：Baseline, 1 month, 3 months
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Caregiver depression was measured using the Center for Epidemiologic Studies Depression scale (CES-D).
The CES-D contains 20 items with a 4-point Likert scale ranging from 0 = rarely or none of the time (i.e., less than 1 day in past week) to 3 = most or all of the time (i.e., 5-7 days in past week).
A higher score indicates greater depression (range = 0-60).
The CES-D shows adequate internal consistency (α = .84-.90), moderate convergent validity with other depression scales (r = .44-.75), and has been shown to effectively measure change in psychoeducational interventions for dementia caregivers.
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Baseline, 1 month, 3 months
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Change in Caregiver Health and Wellbeing - Competence
時間枠：Baseline, 1 month, 3 months
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Caregiver sense of competence was measured using the Short Sense of Competence Questionnaire (SSCQ).37
The SSCQ contains seven negatively worded items (e.g., "I feel strained in my interaction with...").
Each item is rated on a five-point Likert scale and dichotomized to agree (i.e., agree very strongly, agree, neutral) or disagree (i.e., disagree or strongly disagree).
The items where the caregiver disagreed are summed for the total score.
A higher score indicates a higher sense of competence (range = 0-7).
The SSCQ shows adequate internal consistency (α = .76)
and concurrent validity with the original Sense of Competence Questionnaire (r = .88).
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Baseline, 1 month, 3 months
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Change in Caregiver Health and Wellbeing - Sleep Disturbance
時間枠：Baseline, 1 month, 3 months
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Caregiver sleep disturbance was measured by the Pittsburgh Sleep Quality Index (PSQI).
The PSQI contains 19 items with a 4-point Likert scale across seven domains: sleep quality, sleep latency, sleep duration, habitual sleep ef- ficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction.
A higher global score indicates worse sleep quality (range = 0-21).
The PSQI shows adequate internal consistency (α = .83)
and adequate validity in differentiating patients with and without sleep disorders.
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Baseline, 1 month, 3 months
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Change in Caregiver Health and Wellbeing - Medication Use
時間枠：Baseline, 1 month, 3 months
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Caregivers taking PRN anxiolytics, hypnotics, or antipsychotic medication.
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Baseline, 1 month, 3 months
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Change in Caregiver Health and Wellbeing - Confidence in Managing BPSD
時間枠：Baseline, 3 months
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Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005).
The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005).
Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident).
At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges.
Improvement was indicated increase in confidence from baseline to 3-months.
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Baseline, 3 months
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Change in Caregiver Health and Wellbeing - Confidence in Managing Disease Expectations
時間枠：Baseline, 3 months
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Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005).
The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005).
Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident).
At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges.
Improvement was indicated increase in confidence from baseline to 3-months.
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Baseline, 3 months
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Change in Caregiver Health and Wellbeing - Confidence in Managing ADLs (Activities of Daily Living)
時間枠：Baseline, 3 months
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Caregivers reported their three priority care challenges at baseline using the Caregiver Target Problems Questionnaire (Teri, McCurry, Logsdon, & Gibbons, 2005).
The Caregiver Target Problems Questionnaire was adapted and used to identify caregiver priority care challenges for frequency, severity, and confidence at baseline and 3-months (Teri et al., 2005).
Prior to group allocation, caregivers identified three priority care challenges and rated them on 5-point Likert scales: frequency of the challenge (0 = None to 4 = Daily or more often), severity of the challenge (0 = Trivial to 4 = Severe), and confidence in managing the challenge (0 = Unable to manage to 4 = Very confident).
At the end of the 3-month trial, caregivers repeated their ratings of the baseline care challenges.
Improvement was indicated increase in confidence from baseline to 3-months.
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Baseline, 3 months
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Change in Caregiver Reported Challenging Behaviors - Reaction to Disruptive Symptoms (Bother)
時間枠：Baseline, 1 month, 3 months
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Caregiver reaction to behavioral symptoms of the PLWD was measured by the Revised Memory and Problem Behavior Checklist (RMPBC).
The RMPBC contains 24 items, each with two parts.
Each item represents a behavior; if the behavior has been exhibited by the PLWD in the past week, the caregiver reports the behavior as present.
If the behavior is present, the caregiver then reports "how much it bothered you?" on a five-point Likert scale (0 = not at all; 4 = extremely).
If the behavior was not present, no "bother" score is provided, and the item is scored 0. The items are summed for a total score (range = 0-96) and for three subscales representing bother due to memory-related problems (range = 0-28), depressive symptoms (range = 0-36), and disruptive symptoms (range = 0-32).
A higher score indicates a greater negative reaction to behaviors.
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Baseline, 1 month, 3 months
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Change in Caregiver Reported Challenging Behaviors - Frequency of Disruptive Behaviors
時間枠：Baseline, 1 month, 3 months
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Frequency of disruptive behaviors measured by the Revised Memory and Problem Behavior Checklist (RMPBC).
The RMPBC contains 24 items.
Each item represents a behavior; if the behavior has been exhibited by the person with dementia in the past week, the caregiver reports the behavior as present.
There are 8 disruptive behaviors questions.
Range is 0-8.
A decrease in disruptive behaviors is an improvement.
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Baseline, 1 month, 3 months
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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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Cost for FamTechCare Treatment Compared to Control Group
時間枠：3 months
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Process-based costing for the FamTechCare group compared to the control group.
Costs reflect the total cost for the program per dyad per week.
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3 months
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Cost for FamTechCare Treatment Compared to Control Group - ICER
時間枠：3 months
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Incremental Cost-effectiveness Ratio (ICER) for Significant Primary Outcomes: Depression and Competence.
Costs reflect the total cost for the program per dyad per week to achieve effect in each outcome.
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3 months
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協力者と研究者
捜査官
- 主任研究者：Kristine N Williams, RN, PhD、University of Kansas Medical Center
出版物と役立つリンク
一般刊行物
- Williams K, Arthur A, Niedens M, Moushey L, Hutfles L. In-home monitoring support for dementia caregivers: a feasibility study. Clin Nurs Res. 2013 May;22(2):139-50. doi: 10.1177/1054773812460545. Epub 2012 Sep 20.
- Kim S, Shaw C, Williams KN, Hein M. Typology of Technology-Supported Dementia Care Interventions From an In-Home Telehealth Trial. West J Nurs Res. 2019 Dec;41(12):1724-1746. doi: 10.1177/0193945919825861. Epub 2019 Jan 28.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
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。
FamTechCareの臨床試験
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University of KansasNational Institutes of Health (NIH)完了