A Phase 1/2 interventional study of The Family Caregiver Training Program in Dementia, sponsored by Nova Southeastern University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-07.
Sponsored by Nova Southeastern University · Phase 1/2, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 36 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
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.
Behavioral: The Family Caregiver Training Program
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.
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.
Caregiver Change in Activities of Daily Living Knowledge
The ADL Knowledge Test is an 18-item, multiple-choice measure of caregiver assistance.
Time frame: 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
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.
Time frame: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
The Zarit Burden Interview (22-item)
The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.
Time frame: Pretest and 3-months posttest
The Beck Depression Inventory II
The Beck Depression Inventory-II (Beck, Steer, Ball, \& Ranieri, 1996; Gallagher, Nies, \& Thompson, 1982) was used to measure caregiver depression.
Time frame: Pretest and 3-months posttest
WHOQOL-BREF
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.
Time frame: Pretest and 3-months posttest
Occupational Performance
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).
Time frame: Pretest and 3-months posttest
Occupational Satisfaction
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).
Time frame: Pretest and 3-months posttest
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Nova Southeastern University