NCT02690896

Brief Summary

The purpose of this study is to examine the effectiveness of support group intervention for primary caregivers of a person with dementia or similar cognitive impairment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 24, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2.4 years

First QC Date

January 11, 2016

Last Update Submit

June 22, 2021

Conditions

DementiaAlzheimer's Disease

Keywords

caregiver burdencaregiver support groups

Outcome Measures

Primary Outcomes (1)

  • Change in Long-Term Care Utilization based on Caregiver Report

    Caregivers will be asked where there care recipient lives at baseline, and then their current living status thereafter to know if and when a transition to a long-term care facility occurs.

    baseline, 6 weeks, and then every 6 months for 5 years

Secondary Outcomes (9)

  • Neuropsychiatric symptoms

    baseline, 6 weeks, and then every 6 months for 5 years

  • Caregiver strain

    baseline, 6 weeks, and then every 6 months for 5 years

  • Caregiver depression

    baseline, 6 weeks, and then every 6 months for 5 years

  • Caregiver preparedness

    baseline, 6 weeks, and then every 6 months for 5 years

  • Satisfaction Survey

    at 6 weeks

  • +4 more secondary outcomes

Study Arms (2)

UCF Behavioral Intervention Group

EXPERIMENTAL

The intervention group will be the UCF Caregiver Support. Participants will receive a 90 minute group session, once a week, for a period of 6 consecutive weeks.

Behavioral: UCF Caregiver Support Group

Community Comparison Group

ACTIVE COMPARATOR

Comparison group members will come from potential local support groups include, but are not limited to, the support group at the Faith Assembly of God church, the caregiver support group at the First Baptist Church of Orlando, and the caregiver support group at the Alzheimer's and Dementia Resource Center.

Behavioral: Community Support Groups

Interventions

UCF Caregiver Support GroupBEHAVIORAL

The intervention will be a 90 minute group session, once a week, for a period of 6 consecutive weeks. The intervention will teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment and encourage caregiver self-care.

UCF Behavioral Intervention Group
Community Support GroupsBEHAVIORAL

Comparison group members will come from local community support groups, which typically include components of social support and limited psychoeducation, and are relatively unstructured.

Community Comparison Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants must be currently providing care to a demented or cognitively impaired adult
  • All participants must live in the United States.
  • Participants in the community comparison group must be currently enrolled in a caregiver support group in the community (i.e., not the UCF caregiver support group).

You may not qualify if:

  • \- Participants who do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

Related Publications (1)

  • Gonyea JG, O'Connor MK, Boyle PA. Project CARE: a randomized controlled trial of a behavioral intervention group for Alzheimer's disease caregivers. Gerontologist. 2006 Dec;46(6):827-32. doi: 10.1093/geront/46.6.827.

    PMID: 17169938BACKGROUND

Related Links

MeSH Terms

Conditions

DementiaAlzheimer DiseaseCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Daniel L Paulson, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 24, 2016

Study Start

February 24, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study-related materials Access

Locations

US(1)