search
Back to results

Caring for the Caregiver Network

Primary Purpose

Caregivers of Alzheimer's Disease or Memory Problem Patients

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caregiving condition
Nutrition condition
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Caregivers of Alzheimer's Disease or Memory Problem Patients focused on measuring Alzheimer's caregivers, Technology-based intervention, Culturally-tailored intervention

Eligibility Criteria

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

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

Sites / Locations

  • University of Miami Miller School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caregiving Condition

Nutrition Condition

Arm Description

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

Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition.

Outcomes

Primary Outcome Measures

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.
Caregiving Burden as Measured by Burden Inventory
Higher score means greater level of caregiver burden. Range (0-44)
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2017
Last Updated
June 6, 2019
Sponsor
University of Miami
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT03049501
Brief Title
Caring for the Caregiver Network
Official Title
A Tailored Technology Intervention for Diverse Caregivers of AD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers of Alzheimer's Disease or Memory Problem Patients
Keywords
Alzheimer's caregivers, Technology-based intervention, Culturally-tailored intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caregiving Condition
Arm Type
Experimental
Arm Description
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
Arm Title
Nutrition Condition
Arm Type
Placebo Comparator
Arm Description
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition.
Intervention Type
Behavioral
Intervention Name(s)
Caregiving condition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutrition condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)
Description
CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Caregiving Burden as Measured by Burden Inventory
Description
Higher score means greater level of caregiver burden. Range (0-44)
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Caregiver's Self Report of Self-care
Description
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.
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Caregiver's Self-report of Physical Health
Description
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.
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Caregiver's Self-efficacy
Description
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.
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up
Title
Positive Aspects of Caregiving
Description
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.
Time Frame
Baseline, 6-mth follow-up and 12-mth follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Speak and understand English or Spanish Provide care to a loved one with memory decline Not having terminal illness/condition 18+ yrs old Exclusion Criteria: Not providing care to a loved one with Alzheimer disease or dementia Not speak English or Spanish Have cognitive deficit Have terminal illness Plan to place their loved one in a facility Plan to move away in the next 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Loewenstein, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Caring for the Caregiver Network

We'll reach out to this number within 24 hrs