The Family Caregiver Training Program for Caregivers of People With Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649244
• Other study ID #: 12181423Exp
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 4, 2016
• Last updated: January 5, 2016
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	Alzheimer's Association

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Change in Activities of Daily Living Knowledge	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.	No
Primary	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.	Pretest (i.e., immediately before training) to Posttest (i.e., immediately after training-on the same day) and 3-Months Posttest.	No
Secondary	The Zarit Burden Interview (22-item)	The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.	Pretest and 3-months posttest	No
Secondary	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.	Pretest and 3-months posttest	No
Secondary	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.	Pretest and 3-months posttest	No
Secondary	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).	Pretest and 3-months posttest	No
Secondary	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).	Pretest and 3-months posttest	No