WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers
29 mars 2022 uppdaterad av: Frederic C. Blow, University of Michigan
This research will test the WeCareAdvisor tool for family caregivers of military veterans with dementia to help caregivers assess, manage and track behavioral symptoms and their contributing factors (e.g., pain, sleep disturbance), and that provides tailored strategies for in-home, medication-free behavior management.
60 caregiver-person with dementia dyads will be recruited (30 Treatment Group, 30 Wait-List Control Group).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Eligible caregivers must:
- Be the primary caregiver of a military veteran with dementia for at least 6 months and planning to remain the primary caregiver for the next 2 months
- Currently living with the person they are caring for (care recipient)
- Comfortable utilizing technology (e.g. computers, tablets, the internet)
- Have access to the internet and a computer or tablet device
- Plans to live in the area for the duration of the study
Care recipients (military veteran living with dementia) must:
- Exhibit at least one or more behavioral symptoms (any behavior at any frequency)
- Receiving psychotropic medication or cognitive enhancers will not exclude the care recipient.
- Have a clinical diagnosis of dementia (any type) per caregiver report.
- Be a military veteran.
Exclusion Criteria:
- Inability to read, speak or understand English
- Lack of regular access to a telephone, internet, technology (tablet or computer)
- Caregiver is unable to use a computer or tablet
- Person with dementia is not a military veteran
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: WeCareAdvisor
immediate use of the WeCareAdvisor tool for a 1 month period
|
Tailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia.
During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur.
|
|
Aktiv komparator: WeCareAdvisor after 1 month
after a wait period of 1 month, use of the WeCareAdvisor tool for a 1 month period
|
Tailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia.
During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Caregiver Stress
Tidsram: Baseline to 2 months
|
As measured by a study specific questionnaire completed by caregivers.
Stress is measured on a scale of 1 to 5 where 1 is equivalent to no stress and 5 is equivalent to extreme stress.
|
Baseline to 2 months
|
|
Change in Caregiver Confidence in Managing Problematic Behavior
Tidsram: Baseline to 2 months
|
As measured by a study specific questionnaire completed by caregivers.
Confidence in managing problematic behavior is measured on a scale of 0 to 10, where a score of 0 means not confident and 10 means extremely confident
|
Baseline to 2 months
|
|
Change in Caregiver Upset
Tidsram: Baseline to 2 months
|
As measured by a study specific questionnaire completed by caregivers.
Upset is measured on a scale of 0 to 5 where 0 is equivalent to no upset and 5 is equivalent to extreme upset (midpoint is equivalent to fairly upset).
|
Baseline to 2 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Caregiver Communication
Tidsram: Baseline to 2 months
|
Caregivers rate the frequency of using six forms of negative communication (yelling, threatening, criticizing, withdrawing from patient, using harsh tone and screaming), measured on a scale of 1 to 5 where a score of 1 is never and a score of 5 is always.
|
Baseline to 2 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Ease of Use of the WeCareAdvisor Tool
Tidsram: 1 month after using WeCareAdvisor tool
|
As measured by a study specific questionnaire completed by caregivers.
Ease of use of the WeCareAdvisor tool is measured on a scale of 1 to 7 where 1 is equivalent to strongly disagree and 7 is equivalent to strongly agree (midpoint is equivalent to neutral).
|
1 month after using WeCareAdvisor tool
|
|
Usefulness/ Perceived Benefit of the WeCareAdvisor Tool
Tidsram: 1 month after using WeCareAdvisor tool
|
As measured by a study specific questionnaire completed by caregivers.
Usefulness/perceived benefit of the WeCareAdvisor tool is measured on a scale of 1 to 7 where 1 is equivalent to strongly disagree and 7 is equivalent to strongly agree (midpoint is equivalent to neutral).
|
1 month after using WeCareAdvisor tool
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
19 oktober 2020
Primärt slutförande (Faktisk)
21 oktober 2021
Avslutad studie (Faktisk)
21 oktober 2021
Studieregistreringsdatum
Först inskickad
7 oktober 2020
Först inskickad som uppfyllde QC-kriterierna
7 oktober 2020
Första postat (Faktisk)
14 oktober 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 mars 2022
Senast verifierad
1 mars 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HUM00117707
- W81XWH-16-1-0551 (Annat bidrag/finansieringsnummer: United States Department of Defense)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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