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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
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

    First Posted
    January 4, 2016
    Last Updated
    January 5, 2016
    Sponsor
    Nova Southeastern University
    Collaborators
    Alzheimer's Association
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    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
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    The Family Caregiver Training Program for Caregivers of People With Dementia

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