Clinical trial NCT02649244: The Family Caregiver Training Program for Caregivers of People With Dementia
Official title: The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dementia
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2016-01-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Change in Activities of Daily Living Knowledge
timeFrame: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
measure: Caregiver Change in Confidence
timeFrame: Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.
Secondary outcomes:
measure: The Zarit Burden Interview (22-item)
timeFrame: Pretest and 3-months posttest
measure: The Beck Depression Inventory II
timeFrame: Pretest and 3-months posttest
measure: WHOQOL-BREF
timeFrame: Pretest and 3-months posttest
measure: Occupational Performance
timeFrame: Pretest and 3-months posttest
measure: Occupational Satisfaction
timeFrame: Pretest and 3-months posttest
Other outcomes:
Locations:
Study officials:
References:
citation: DiZazzo-Miller R, Samuel PS, Barnas JM, Welker KM. Addressing everyday challenges: feasibility of a family caregiver training program for people with dementia. Am J Occup Ther. 2014 Mar-Apr;68(2):212-20. doi: 10.5014/ajot.2014.009829.