Caring for the Caregiver Network

June 6, 2019 updated by: David Loewenstein, University of Miami

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6-mth follow-up and 12-mth follow-up
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)
Baseline, 6-mth follow-up and 12-mth follow-up
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.
Baseline, 6-mth follow-up and 12-mth follow-up
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.
Baseline, 6-mth follow-up and 12-mth follow-up
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.
Baseline, 6-mth follow-up and 12-mth follow-up
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.
Baseline, 6-mth follow-up and 12-mth follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Loewenstein, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 20, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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