Caring for the Caregiver Network

A Tailored Technology Intervention for Diverse Caregivers of AD Patients

The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.

Study Overview

• Status: Completed
• Conditions: Caregivers of Alzheimer's Disease or Memory Problem Patients
• Intervention / Treatment: Behavioral: Caregiving condition; Behavioral: Nutrition condition

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Speak and understand English or Spanish
2. Provide care to a loved one with memory decline
3. Not having terminal illness/condition
4. 18+ yrs old

Exclusion Criteria:

1. Not providing care to a loved one with Alzheimer disease or dementia
2. Not speak English or Spanish
3. Have cognitive deficit
4. Have terminal illness
5. Plan to place their loved one in a facility
6. Plan to move away in the next 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregiving Condition; Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics	Behavioral: Caregiving condition; The intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes.
Placebo Comparator: Nutrition Condition; Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition.	Behavioral: Nutrition condition; The intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)	CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.	Baseline, 6-mth follow-up and 12-mth follow-up
Caregiving Burden as Measured by Burden Inventory	Higher score means greater level of caregiver burden. Range (0-44)	Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self Report of Self-care	A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.	Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self-report of Physical Health	SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.	Baseline, 6-mth follow-up and 12-mth follow-up
Caregiver's Self-efficacy	A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.	Baseline, 6-mth follow-up and 12-mth follow-up
Positive Aspects of Caregiving	An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.	Baseline, 6-mth follow-up and 12-mth follow-up

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: David Loewenstein, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 10, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Technology-based intervention; Alzheimer's caregivers; Culturally-tailored intervention
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 20130460; R01NR014434 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No