Completed

NCT Number: NCT03049501

Caring for the Caregiver Network

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.

Completed

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Key information

Conditions

Caregivers of Alzheimer's Disease or Memory Problem Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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.
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)
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.
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.
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.
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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

National Institute of Nursing Research (NINR)

Registry information

Official study title

A Tailored Technology Intervention for Diverse Caregivers of AD Patients

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Feb 10, 2017
Registry last updated: Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.