- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02649244
The Family Caregiver Training Program for Caregivers of People With Dementia
The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The main research question asks to what extent does participation in a structured 3-hour training module (i.e., The Family Caregiver Training Program) focused on assisting family caregiver's with the ADLs of people with dementia effect caregiver knowledge and confidence, which in turn may effect caregiver burden, depression, quality of life, and occupational performance and satisfaction. Aim 1 will examine the relationship between the Family Caregiver Training Program intervention and knowledge of and confidence in the occupation of caregiving. Aim 2 will explore the relationship between the occupation of caregiving and person characteristics including burden, depression, and quality of life. Aim 3 will explore the relationship between the changes in the occupation of caregiving and changes in occupational performance.
A feasibility of the Family Caregiver Training Program was established using a single pre- post- test design. A significant improvement in caregiver knowledge was found in all three areas of training: communication/nutrition (N=53, p<0.001), transfers and toileting (N=46, p=0.003), and bathing and dressing (N=45, p=0.10) (DiZazzo-Miller, Samuel, Barnas, & Welker, 2014). This proposed study is built on the feasibility study, with the addition of confidence, burden, depression, quality of life, and occupational performance and satisfaction as outcomes using a random assignment to control group design.
A convenience sample of 36 family caregivers was recruited through flyers, newsletters, and Alzheimer's Association media outlets. The intervention group received one two-hour training that included three modules. Module one presented information on communication, eating/feeding and nutrition; module two focused on transfers and toileting; and module three focused on bathing, grooming, and dressing. The control group received standard care based upon a packet developed by the Alzheimer's Association for physicians to distribute to families and caregivers after receiving a diagnosis of dementia.
Results from this study will be generalizable to Metro-Detroit area family caregivers. Findings may offer information to enhance the caregiver training literature in the field of occupational therapy on the impact a community-based activity of daily living training can have with dementia family caregivers.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
- Fase 1
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Primary family caregiver as providing at least 4 hours/day of care at least 5 days/week
- At least 18 years of age
- Able to read and understand the English language
- Care recipients must have received an Alzheimer's or related dementia diagnosis
Exclusion Criteria:
- Caregivers who provide less than 4 hours/day of care at least 5 days/week
- Under 18 years of age
- Unable to read or understand the English language
- Have care recipients who have not received an Alzheimer's or related dementia diagnosis
- Formally trained/paid caregivers
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: The Family Caregiver Training Program
The experimental group received a 2 hour intervention training on activities of daily throughout the early, middle, and late stages of dementia including communication, eating/feeding, nutrition, bathing, grooming, dressing, toileting, and transferring.
|
The intervention consisted of a two-hour PowerPoint® presentation throughout three modules (i.e., communication, eating/feeding, and nutrition; transferring and toileting; and dressing, bathing, and grooming).
Each module was followed by a hands-on demonstration and practice session, including how to properly position and feed an adult, transfer from a seated position to another seated position, and a case study on modifications and assistance to provide during dressing and grooming.
|
Geen tussenkomst: Standard Care
The control group received a 1 1/2 hour training, however the information was based on what has been deemed standard care by the Alzheimer's Association.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Caregiver Change in Activities of Daily Living Knowledge
Tijdsspanne: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
|
The ADL Knowledge Test is an 18-item, multiple-choice measure of caregiver assistance.
|
Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
|
Caregiver Change in Confidence
Tijdsspanne: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
|
The Caregiver Confidence Scale (Lewis et al., 2010) is a modified nine-item confidence scale used to assess caregiver confidence in their skills for caring, understanding of the stages of dementia, and communication with their care recipient.
|
Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
The Zarit Burden Interview (22-item)
Tijdsspanne: Pretest and 3-months posttest
|
The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.
|
Pretest and 3-months posttest
|
The Beck Depression Inventory II
Tijdsspanne: Pretest and 3-months posttest
|
The Beck Depression Inventory-II (Beck, Steer, Ball, & Ranieri, 1996; Gallagher, Nies, & Thompson, 1982) was used to measure caregiver depression.
|
Pretest and 3-months posttest
|
WHOQOL-BREF
Tijdsspanne: Pretest and 3-months posttest
|
The World Health Organization Quality of Life (Brief) measure (WHO-QOL-BREF) was used to measure four domains, including physical health, psychological, social relationships, and environment.
|
Pretest and 3-months posttest
|
Occupational Performance
Tijdsspanne: Pretest and 3-months posttest
|
This scale consists of asking one question related to performance for each of the three ADL modules within the Family Caregiver Training Program using a Likert scale of 1 to 10 (1 as not at all and 10 as extremely) on how well caregivers perform their occupation of caregiving.
This was adapted from the Canadian Occupational Performance Measure (COPM).
|
Pretest and 3-months posttest
|
Occupational Satisfaction
Tijdsspanne: Pretest and 3-months posttest
|
This scale consists of asking one question related to satisfaction for each of the three ADL modules within the Family Caregiver Training Program using a Likert scale of 1 to 10 (1 as not at all and 10 as extremely) on how satisfied caregivers are with their occupation of caregiving.
This was adapted from the Canadian Occupational Performance Measure (COPM).
|
Pretest and 3-months posttest
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12181423Exp
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
-
Hospices Civils de LyonWervingClinical Dementia Rating (CDR) van de analyse van medisch dossier | Clinical Dementia Rating (CDR) Face-to-face interview met de patiëntFrankrijk
Klinische onderzoeken op The Family Caregiver Training Program
-
University of KentuckyVoltooidAandachtstekort en storende gedragsstoornissen | Ouderschap | GehoorverliesVerenigde Staten
-
Williams LifeSkillsNational Institute on Aging (NIA)Voltooid
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)Voltooid
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University of... en andere medewerkersActief, niet wervendNeurologische ontwikkelingsstoornissen | GedragsstoornissenCanada
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)VoltooidOppositioneel opstandige stoornis | GedragsstoornisCanada
-
Mathematica Policy Research, Inc.Office of Population Affairs; California Department of Public Health, MCAHVoltooidPreventie van tienerzwangerschappenVerenigde Staten
-
Memorial Sloan Kettering Cancer CenterBeëindigdDe familie of verwanten van patiënten die bij MSKCC zijn behandeld voor niet-cutane plaveiselcelcarcinomen van de | Bovenste spijsverteringskanaalVerenigde Staten
-
University of CopenhagenUniversity of Groningen; VU University of Amsterdam; University College Copenhagen en andere medewerkersWervingGezond | Emotie regulatie | Taal ontwikkeling | Interactieve Skills Daycare ProvidersDenemarken
-
Columbia UniversityWorld Bank; United NationsVoltooid
-
National Taiwan University HospitalNog niet aan het wervenPost-cardiale chirurgie | Longexpansietherapie