Mobile Tablet Education to Advance Caregiver Health (MTEACHing)
24 april 2019 bijgewerkt door: VA Office of Research and Development
Mobile Media Intervention for Family Caregivers of Veterans With Dementia
To address the high burden of caring for a Veteran with dementia, the investigators propose to study the effect of a low-cost, rehabilitative intervention for family caregivers of Veterans with dementia.
The investigators' novel approach will use mobile media technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers.
If this rehabilitative intervention proves successful, it may represent an approach to Veteran and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The proposed project studies the effects of an education and skill-building rehabilitation intervention, designed to be low-cost and clinically translatable through mobile media devices (i.e., tablets), on family caregivers of Veterans with dementia. Intervention effects will be examined longitudinally at baseline and 3 months post-intervention.
Advanced statistical techniques will be used to determine the impact of the intervention on: quality of life in caregivers of Veterans with dementia (Aim 1), perceived stress and depressive symptoms in caregivers (Aim 2), and socialization and engagement in pleasant activities in caregivers (Aim 3).
If this rehabilitative intervention proves successful, it may represent an approach to Veteran- and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
16
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Palo Alto, California, Verenigde Staten, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
-- Participants must:
- report distress associated with being the primary caregiver for a family member with dementia
- reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
- provide at least 7 hours of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members)
- cohabitate with a Veteran diagnosed with dementia
- be proficient in spoken and written English
- be capable of providing informed consent
Exclusion Criteria:
-- Potential participants will be screened and excluded for:
- current or lifetime history of any psychiatric disorder with psychotic features
- prominent suicidal or homicidal ideation
- having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
- presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
- diagnosis of probable or possible dementia
- a Telephone Cognitive Screen score of < 20
- participation in another caregiver intervention study within the past year
- lack of access to telephone and internet services in the home
- illness that would prevent study participation
- planned transfer of care receiver to another caregiver or nursing home within 6 months
- currently living with an implantable cardioverter defibrillator or pacemaker
- known pregnancy at time of consent
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Mobile Media Education and Skill-Building Rehabilitation Int
The investigators' ESBR-m intervention consists of four, 90-minute group (= 5 participants) sessions.
These four sessions are supplemented with a booster session one month following the last intervention session.
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Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions.
These four sessions are supplemented with a booster session one month following the last intervention session.
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Actieve vergelijker: Usual Care
Usual Care (plus supplemental educational materials).
Participants randomized to the Usual Care (UC) group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
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Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's "Understanding Memory Loss").
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
Tijdsspanne: Baseline, 4 month follow-up
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The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden.
Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers.
Scores for each item range from 0 (never) to 4 (nearly always) on questions such as "Do you feel embarrassed by your relative's behavior?."
Total scores are calculated by summing all responses and range from 0-88.
A higher score is indicative of a worse outcome.
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Baseline, 4 month follow-up
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Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
Tijdsspanne: Baseline, 4 month follow-up
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The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period.
The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention.
Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded.
Total scores are calculated by summing all responses and range from 0-60.
A higher score is indicative of a worse outcome.
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Baseline, 4 month follow-up
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Change From Baseline Perceived Stress Scale (PSS) at 4 Months
Tijdsspanne: Baseline, 4 month follow-up
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The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress.
It is a measure of the degree to which situations in one's life are appraised as stressful.
Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives.
The scale also includes a number of direct queries about current levels of experienced stress.
We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56.
Lower values indicate lower perceived stress while higher values indicate higher perceived stress.
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Baseline, 4 month follow-up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Blake K Scanlon, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2015
Primaire voltooiing (Werkelijk)
31 december 2017
Studie voltooiing (Werkelijk)
30 juni 2018
Studieregistratiedata
Eerst ingediend
23 januari 2018
Eerst ingediend dat voldeed aan de QC-criteria
30 januari 2018
Eerst geplaatst (Werkelijk)
31 januari 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
24 april 2019
Laatst geverifieerd
1 januari 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- E1710-P
- 1I21RX001710 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Dementie
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Hospices Civils de LyonWervingClinical Dementia Rating (CDR) van de analyse van medisch dossier | Clinical Dementia Rating (CDR) Face-to-face interview met de patiëntFrankrijk