The Family Caregiver Training Program for Caregivers of People With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
The Family Caregiver Training Program
Sponsored by

About this trial
This is an interventional supportive care trial for Dementia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The Family Caregiver Training Program
Standard Care
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Caregiver Change in Activities of Daily Living Knowledge
The ADL Knowledge Test is an 18-item, multiple-choice measure of caregiver assistance.
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.
Secondary Outcome Measures
The Zarit Burden Interview (22-item)
The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.
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.
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.
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).
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).
Full Information
NCT ID
NCT02649244
First Posted
January 4, 2016
Last Updated
January 5, 2016
Sponsor
Nova Southeastern University
Collaborators
Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT02649244
Brief Title
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
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
Alzheimer's Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Family Caregiver Training Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Family Caregiver Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver Change in Activities of Daily Living Knowledge
Description
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.
Title
Caregiver Change in Confidence
Description
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.
Secondary Outcome Measure Information:
Title
The Zarit Burden Interview (22-item)
Description
The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.
Time Frame
Pretest and 3-months posttest
Title
The Beck Depression Inventory II
Description
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
Title
WHOQOL-BREF
Description
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
Title
Occupational Performance
Description
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
Title
Occupational Satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
24581408
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.
Results Reference
background
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The Family Caregiver Training Program for Caregivers of People With Dementia
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