NCT02649244

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 4, 2016

Last Update Submit

January 5, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Secondary Outcomes (5)

  • The Zarit Burden Interview (22-item)

    Pretest and 3-months posttest

  • The Beck Depression Inventory II

    Pretest and 3-months posttest

  • WHOQOL-BREF

    Pretest and 3-months posttest

  • Occupational Performance

    Pretest and 3-months posttest

  • Occupational Satisfaction

    Pretest and 3-months posttest

Study Arms (2)

The Family Caregiver Training Program

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

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.

The Family Caregiver Training Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 24581408BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 7, 2016

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01