Caring for the Caregiver Network

NCT03049501 | Completed Results DMC

• 2 other identifiers: 20130460R01NR014434
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers of Alzheimer's Disease or Memory Problem Patients

Keywords

Alzheimer's caregivers; Technology-based intervention; Culturally-tailored intervention

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Caregiving Condition

EXPERIMENTAL

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

Nutrition Condition

PLACEBO COMPARATOR

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

Behavioral: Nutrition condition

Interventions

Caregiving condition BEHAVIORAL

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.

Caregiving Condition

Nutrition condition BEHAVIORAL

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.

Nutrition Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Speak and understand English or Spanish
• Provide care to a loved one with memory decline
• Not having terminal illness/condition
• + yrs old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Results Point of Contact

• Title: David Loewenstein
• Organization: University of Miami

dloewenstein@miami.edu

305-355-7016

Study Officials

• David Loewenstein, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: July 1, 2013
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)