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WeCareAdvisor: A Web-Based Tool to Improve Quality of Life for Military Veterans With Dementia and Their Caregivers

29. marts 2022 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

19

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: WeCareAdvisor
immediate use of the WeCareAdvisor tool for a 1 month period
Adfærdsmæssigt: WeCareAdvisor
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
Adfærdsmæssigt: WeCareAdvisor
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Caregiver Stress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Caregiver Communication
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ease of Use of the WeCareAdvisor Tool
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Michigan

Samarbejdspartnere

United States Department of Defense

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2020

Primær færdiggørelse (Faktiske)

21. oktober 2021

Studieafslutning (Faktiske)

21. oktober 2021

Datoer for studieregistrering

Først indsendt

7. oktober 2020

Først indsendt, der opfyldte QC-kriterier

7. oktober 2020

Først opslået (Faktiske)

14. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUM00117707
  • W81XWH-16-1-0551 (Andet bevillings-/finansieringsnummer: United States Department of Defense)

Plan for individuelle deltagerdata (IPD)

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