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The Family Caregiver Training Program for Caregivers of People With Dementia

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ClinicalTrials.gov Identifier: NCT02649244
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Rosanne DiZazzo-Miller, Nova Southeastern University

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.

Condition or disease Intervention/treatment Phase
Dementia Behavioral: The Family Caregiver Training Program Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Family Caregiver Training Program for Caregivers of People With Dementia: A Randomized Control Trial
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Caregiver Change in Activities of Daily Living Knowledge [ Time Frame: 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.

  2. Caregiver Change in Confidence [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Zarit Burden Interview (22-item) [ Time Frame: Pretest and 3-months posttest ]
    The Zarit Burden Interview (Zarit et al., 1980) is a measure of perceived caregiver burden.

  2. The Beck Depression Inventory II [ Time Frame: 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.

  3. WHOQOL-BREF [ Time Frame: 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.

  4. Occupational Performance [ Time Frame: 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).

  5. Occupational Satisfaction [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications:
Responsible Party: Rosanne DiZazzo-Miller, PhD Candidate, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02649244     History of Changes
Other Study ID Numbers: 12181423Exp
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders