Families Coping Together With Alzheimer's Disease (FACT-AD)

December 16, 2024 updated by: Yale University
Two remote phone/zoom calls are required to assess experiences as a family coping with dementia.

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.

Detailed Description

Using a combination of paper or online surveys in addition to interactive visits with blood pressure monitoring, participants are observed interacting with each other. Blood pressure devices are mailed to their homes and only worn for six minute intervals. The first visit generally lasts one hour and the second visit 90 minutes.

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.
Observational

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.
354

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
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale School of Public Health

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

No

Sampling Method

Non-Probability Sample

Study Population

In this study, adult children of a parent over 55 with early stage dementia who are responsible for helping parent with at least one task will be recruited

Description

Inclusion Criteria:

  • Parent must be 55 plus with symptoms or a diagnosis of dementia
  • Adult child must be over 18 and involved in some way with assisting parent.

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
dyad
parent with dementia and an adult child who is a caregiver

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
Caregiver demand appraisals
Time Frame: Baseline and one year
(1a) Caregiver demand appraisals: 6 items from the 12-item Zarit Burden Interview (ZBI) will assess caregiver appraisals of demands (e.g., That because of the time you spend with your relative that you don't have enough time for yourself?". Caregivers self-report aspects of burden on a scale from 0 (never) to 4 (nearly always; α= .86). Higher numbers indicate higher demands. Administration is 2.5 minutes
Baseline and one year
Caregiver perceived stress
Time Frame: Baseline and one year later
(1b) Caregiver perceived stress: 6 items from the 12-item Zarit Burden Interview (ZBI) will assess caregiver perceived stress (e.g., "Stressed between caring for your relative and trying to meet other responsibilities (work/family)?"). Caregivers self-report aspects of burden on a scale from 0 (never) to 4 (nearly always; α= .86). Higher numbers indicate higher stress. Administration is 2.5 minutes.
Baseline and one year later
Caregiver negative Coping
Time Frame: Baseline and one year later
The Brief COPE Inventory is a shortened version (28 items) of the COPE inventory in which respondents indicate how often they use a particular coping strategy under stress as ranked on a 4-point scale with 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Examples of items include "I've been using alcohol or drugs to help me get through it." and "I've been criticizing myself" (α=0.72, 0.84, 0.75 for emotion, problem, and dysfunction focused subscales). Higher scores indicate poorer coping. Administration is 10 minutes
Baseline and one year later

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relational Functioning
Time Frame: Baseline and one year later
The Relationships Inventory will measure the degree to which individuals perceive that they can rely on their parent or child for help and support when needed (e.g., "to what extent can you count on your parent/child for help with a problem?" "to what extent can you count on your parent/child to give you honest feedback, even when you might not want to hear it?"). Ratings will be made on a scale from 1 (not at all) to 5 (very much; α=.79). Four additional items will assess the degree to which individuals perceive that their parent/child is a good support-provider (e.g., "overall, my parent/child is a good support-provider" using a scale from 1 (strongly disagree) to 7 (strongly agree). Higher numbers indicate higher relationship functioning. Administration is 5 minutes.
Baseline and one year later
Health
Time Frame: Baseline and one year later
Health-related quality of life will be assessed using the 12-item Short Form Survey (SF-12) version 1.0, documenting the extent of limitations in a number of domains. Higher scores indicate better physical and mental health-related quality of life. It has been used with both persons with ADRD and caregivers. Administration is 5 minutes. The minimum and maximum scores are 0 and 100.
Baseline and one year later

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.
Yale University

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 Institutes of Health (NIH)
National Institute on Aging (NIA)
Department of Health and Human Services

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: Joan Monin, PhD, Yale University

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 (Actual)

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.
June 30, 2019

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.
November 30, 2023

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.
November 30, 2024

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).
November 20, 2020

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.
November 20, 2020

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.
November 24, 2020

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.
March 25, 2025

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.
December 16, 2024

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.
December 1, 2024

More Information

Terms related to this study

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.
  • 2000024219
  • R01AG058565 (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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