- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02489110
Webnovela for Hispanic Dementia Family Caregivers
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The goal of Webnovela program is to evaluate and develop materials for helping caregivers to cope with caregiving, alleviate related distress, and improve their quality of life.
The investigators are evaluating different materials, which may provide caregiving strategies, practical tips and help to enhance caregivers' skills to deal with demanding tasks of caregiving, alleviate related stress, and improve quality of life.
Research Program Steps:
- Caregivers will be asked some simple questions about themselves and their family members to see if they are eligible for the project (fill out Enrollment Form and Informed Consent).
- A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.
- Participants will receive links to online resources, related materials and instructions. The investigators ask participants to access the online resources, read provided brochures and guides, and follow the instructions. Materials are expected to help participants in their caregiver role.
- After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Moffett Field, California, Forenede Stater, 94035-0128
- Photozig, Inc.
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Care for an individual with Alzheimer's Disease or other dementia.
- Have Internet access or own a DVD player.
- Minimum age of 18 years old.
- Belong to Hispanic/Latino ethnic group.
- Spend at least 8 hours/week caring for a person with dementia, which may include assisting, watching, monitoring, or being available to help (e.g. during sleep time)
Exclusion Criteria:
- Severe psychological or physical illness.
- Inability to read and follow Spanish instructions.
- High level of depressive symptoms.
- Unwillingness to participate in all aspects of the study.
Studieplan
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 |
---|---|
Eksperimentel: Webnovela
Caregivers will watch the Webnovela and read related information.
The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving.
A DVD will be available to participants without Internet access.
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Aktiv komparator: Control
Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish.
Participants will receive related materials in Spanish language.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Stress on the Perceived Stress Scale
Tidsramme: 3 months
|
The "Perceived Stress Scale" measures the overall level of stress.
This instrument contains 10 items accessing overall appraisals of stress in the past month.
Minimum score (best value)=0.
Maximum score (worst value)=40.
Higher values represent a worse outcome.
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Caregiver Burden on the Revised Memory and Behavior Problems Checklist
Tidsramme: 3 months
|
This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month.
Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them.
A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred.
The scale refers to the caregiver.
Minimum score (best value)=0.
Maximum score (worst value)=4.
Higher values represent a worse outcome.
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3 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pz-A104a
- R44AG041552 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .