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Health-eBrain Study (HeB)

29. juni 2018 oppdatert av: AnthroTronix, Inc.

Caregivers Virtual Health eBrain Study II

The purposes of this study are to (1) track dementia caregiver health indicators over 12 weeks, both with and without the Mindoula plus DANA intervention (case manager and mobile messaging and assessment applications) to determine if the intervention improves caregiver health and (2) obtain feedback from caregivers to inform on the design of future interventions.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will track the mental status and cognition of caregivers with and without the Mindoula and DANA intervention and use subject feedback to aid in designing future interventions for caregivers.

This is a remotely administered, virtual study targeting dementia caregivers who are mild to moderately depressed. Screening calls for online administration of four surveys to determine inclusion in the study arms. These surveys will be taken on the Health-eBrain website, both at baseline/screening and throughout participation. All other participation will be completed on the participant's mobile phone, and all psychological and cognitive tests will be self-administered.

This study has a between-group design. Participants will be screened for eligibility and then randomized into each arm. The intervention arm will receive the Mindoula plus DANA intervention. The wait list control arm will take the psychological surveys at regular intervals then, after 12 weeks, be enrolled in the DANA-only observation group. The DANA-only group will take DANA and a usability questionnaire.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Silver Spring, Maryland, Forente stater, 20910
        • AnthroTronix Inc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Females and males who regularly provide care for a person with Alzheimer's Disease
  • Between the ages of 45-75
  • Self-reported ability to speak and read English
  • Providing care for at least a year

Participants in the Intervention and Waitlist Control Arms must meet the following additional inclusion criteria:

  • Zarit Burden Inventory (ZBI) Score of 9+
  • Overall M3 score of 33+
  • M3 Depression score of 7+
  • Female Only
  • Minimum hours of caregiving a week must be equal to or greater than 20 hours

Exclusion Criteria:

  • Anyone with a known cognitive diagnosis
  • Anyone with color blindness
  • Overall score of high risk on the M3 and/or high risk on the PTSD or Bipolar subsection of the M3
  • Failure to meet all inclusion criteria per arm

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention Arm
Participants will receive the intervention, Mindoula plus DANA, which involves working with a case manager via an app for 12 weeks. The case manager will help the participant cope with the stresses of caregiving as well as remind them to use the DANA cognitive assessment app. This arm will also take the study's psychological surveys.
Atferdsmessig: Mindoula
The Mindoula intervention is a combination of case management and a messenger application. Case managers monitor how the participant is doing and any needs and provide 24/7 support & assistance, including care coordination, treatment adherence, and matching the participant with providers and community resources. Each participant will be given an intake questionnaire to establish goals and behavioral health history. Participants will use the app and work with the case manager for 12 weeks.
Enhet: DANA
DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency. DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory. Intervention participants will take DANA weekly. The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.
Annen: Waitlist Control Arm
These participants will take psychological surveys and a usability questionnaire for the first 12 weeks of participation, then, for the 12 weeks following, take the psychological surveys along with DANA and a usability questionnaire.
Enhet: DANA
DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency. DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory. Intervention participants will take DANA weekly. The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline M3 Behavioral Scale score over 12 weeks
Tidsramme: At baseline, and 4, 8, and 12 weeks.
At baseline, and 4, 8, and 12 weeks.

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline Zarit Burden Inventory score over 12 weeks
Tidsramme: At baseline, and 4, 8, and 12 weeks.
At baseline, and 4, 8, and 12 weeks.
Change from baseline PROMIS Sleep Disturbance Short Form 8a score over 12 weeks
Tidsramme: At baseline, and 4, 8, and 12 weeks.
At baseline, and 4, 8, and 12 weeks.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Usability Questionnaire
Tidsramme: At baseline, and 4, 8, and 12 weeks.
Survey on using DANA that will help the researchers better understand the development of technologies for this population
At baseline, and 4, 8, and 12 weeks.
Paired Associates Learning
Tidsramme: At baseline and 12 weeks
The PAL assesses visual memory and new learning.
At baseline and 12 weeks
PERMA Profiler
Tidsramme: At baseline and 12 weeks
This survey assesses five core element of psychological well-being and happiness - Positive emotions, Engagement, Relationships, Meaning, and Accomplishments - as well as subjective wellbeing and sense of loneliness.
At baseline and 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AnthroTronix, Inc.

Samarbeidspartnere

Bright Focus Foundation
Mindoula Health Inc.
21st Century Brain Trust
Geoffrey Beene Foundation

Etterforskere

  • Hovedetterforsker: Corinna E Lathan, Ph.D, AnthroTronix, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2016

Primær fullføring (Faktiske)

1. juli 2017

Studiet fullført (Faktiske)

1. juli 2017

Datoer for studieregistrering

Først innsendt

3. august 2016

Først innsendt som oppfylte QC-kriteriene

13. september 2016

Først lagt ut (Anslag)

16. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2018

Sist bekreftet

1. juni 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 091614A

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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