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Caring for the Caregiver Network

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ClinicalTrials.gov Identifier: NCT03049501
Recruitment Status : Completed
First Posted : February 10, 2017
Results First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
David Loewenstein, University of Miami

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.

Condition or disease Intervention/treatment Phase
Caregivers of Alzheimer's Disease or Memory Problem Patients Behavioral: Caregiving condition Behavioral: Nutrition condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Tailored Technology Intervention for Diverse Caregivers of AD Patients
Study Start Date : July 2013
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018


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.




Primary Outcome Measures :
  1. Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.

  2. Caregiving Burden as Measured by Burden Inventory [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    Higher score means greater level of caregiver burden. Range (0-44)

  3. Caregiver's Self Report of Self-care [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    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.

  4. Caregiver's Self-report of Physical Health [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    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.

  5. Caregiver's Self-efficacy [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    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.

  6. Positive Aspects of Caregiving [ Time Frame: Baseline, 6-mth follow-up and 12-mth follow-up ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049501


Locations
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United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: David Loewenstein, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by David Loewenstein, University of Miami:
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Responsible Party: David Loewenstein, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03049501    
Other Study ID Numbers: 20130460
R01NR014434 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2017    Key Record Dates
Results First Posted: June 25, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Loewenstein, University of Miami:
Alzheimer's caregivers
Technology-based intervention
Culturally-tailored intervention
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders