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The Family Caregiver Training Program for Caregivers of People With Dementia

5 gennaio 2016 aggiornato da: Rosanne DiZazzo-Miller, Nova Southeastern University

The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial

The purpose of this study is to examine the effectiveness of the Family Caregiver Training Program for caregivers of people with dementia, using a pretest posttest randomized control trial with 3-month follow-up. The Family Caregiver Training Program will consist of 3-hours and hence, three modules over the course of one day. Module one will present information on communication, eating, and nutrition, module two will focus on transfers and toileting, and module three will focus on bathing, grooming, and dressing. The control group will receive standard care as relevant to dementia family caregivers including general information on the progression of dementia, and helpful resources as suggested by the Alzheimer's Association. A convenience sample of 36 family caregivers will be recruited by flyers posted throughout local area community boards and Alzheimer's Association media outlets. A repeated measures ANOVA will be used to assess the group differences in knowledge and confidence at three time points (pre-intervention, post-intervention, and 3-months post-intervention). Changes in caregiver burden, depression, quality of life, and occupational performance and satisfaction will be assessed 3-months post-intervention.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

36

Fase

  • Fase 2
  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Primary family caregiver as providing at least 4 hours/day of care at least 5 days/week
  2. At least 18 years of age
  3. Able to read and understand the English language
  4. Care recipients must have received an Alzheimer's or related dementia diagnosis

Exclusion Criteria:

  1. Caregivers who provide less than 4 hours/day of care at least 5 days/week
  2. Under 18 years of age
  3. Unable to read or understand the English language
  4. Have care recipients who have not received an Alzheimer's or related dementia diagnosis
  5. Formally trained/paid caregivers

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: The Family Caregiver Training Program
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Caregiver Change in Activities of Daily Living Knowledge
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Zarit Burden Interview (22-item)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nova Southeastern University

Collaboratori

Alzheimer's Association

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2015

Completamento primario (Effettivo)

1 marzo 2015

Completamento dello studio (Effettivo)

1 luglio 2015

Date di iscrizione allo studio

Primo inviato

4 gennaio 2016

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2016

Primo Inserito (Stima)

7 gennaio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 gennaio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 gennaio 2016

Ultimo verificato

1 gennaio 2016

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 12181423Exp

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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