DECIDE: Dyads and Families

NCT05139290 | Recruiting

• 2 other identifiers: STUDY000030561K23AG073516-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to design and test a decision-making program that is tailored to support adult daughters making healthcare decisions for their parents who are living with memory loss to improve the quality of life of African American families. There are two phases of this research study. The first phase will collect information by surveys and/or interviews. The surveys and interviews will ask questions about demographics (e.g., age, race/ethnicity), culture, health, family dynamics, caregiving, and healthcare experiences. The surveys will be completed by all eligible adult daughters and parents with memory loss in pairs. The interviews will be completed by a smaller number of pairs and by all former adult daughter caregivers. The general scope of topics is caregiving experiences, cultural identity, healthcare decisions for persons living with Alzheimer's disease, and related dementias, health, and well-being. The research team will identify and examine key factors that will lead to designing and testing the feasibility of a culturally tailored prototype intervention for African American dementia dyads/families of persons living with mild to moderate Alzheimer's disease and related dementias.

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Outcome Measures

Primary Outcomes (5)

• Participant retention

  Acceptability of the intervention will be assessed with participant retention. Retention of 80% of participants from baseline to 3-month follow-up is considered successful. Attendance of dyads during program sessions during the intervention phase. The goal is to maintain ≥ 70% attendance at program sessions

  eight weeks

• Usability of Intervention

  Usability of the intervention will be assessed with a qualitative interview with the African American parent-adult daughter dyads after completing the intervention. There is not a summary score for the open-ended questions asked during the interview.

  Upon completion of the intervention (estimated to be 8 weeks)

• Percentage of recruitment goal achieved

  The feasibility of the intervention will be assessed as successful recruitment of study participants. This study aims to recruit 20 African American parent-adult daughter dementia dyads in ≤ 6 months. The actual recruited number of dyads will be reported as the percentage of dyads recruited within 6 months divided by 20 (actual/goal).

  Up to 6 months after the start of recruitment

• Change in Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score

  The preliminary efficacy of the intervention will be assessed with the Quality of Life-Alzheimer's Disease (QoL-AD) scale. The QoL-AD has 13 items which are scored as poor = 1, fair = 2, good = 3, excellent = 4. The total score ranges from 13 to 52 and higher scores indicate a greater quality of life.

  0-month, 1 month, 3 months

• Change in Decision Self-Efficacy Scale Score

  The preliminary efficacy of the intervention will be assessed with the Decision Self-Efficacy Scale. The Decision Self-Efficacy Scale has 11 items which are scored as not at all confident = 0 to very confident = 5. The total score ranges from 0 to 100 and higher scores indicate greater self-efficacy.

  0-month, 1 month, 3 months

Study Arms (1)

Prototype Intervention

EXPERIMENTAL

The prototype intervention will be likely family-based and focused on issues of communication, problem-solving, health system literacy, and family systems, all considered in the context of the African-American (AA) adult daughter role and cultural identity.

Behavioral: Prototype Intervention

Interventions

Prototype Intervention BEHAVIORAL

The prototype intervention will be likely family-based and focused on issues of communication, problem-solving, health system literacy, and family systems, all considered in the context of the African-American (AA) adult daughter role and cultural identity.

Prototype Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identifies as African American
• age 50 years or older
• community-dwelling
• experiencing signs and symptoms of mild to moderate dementia through family caregiver report on the Dementia Severity Rating Scale and meeting the National Institute on Aging and the Alzheimer's Association clinical criteria for probable (Alzheimer's Disease (AD)
• able to read, speak, and understand English
• willing to participate.

You may not qualify if:

• any confounding significant neurologic diseases (e.g., Parkinson's) or a major psychiatric disorder (e.g., schizophrenia).
• Caregiver:
• self-identifies as African American
• years of age or older
• daughter/daughter-in-law (including non-blood individuals)
• aids in activities of daily living and/or instrumental activities of daily living for the PLWD
• makes/takes part in formal care decisions
• able to read, speak, and understand English
• cognitively intact
• access to an internet connection
• access to a phone or computer that accepts emails.
• Key informants:
• Meet the criteria for PLWD and caregiver
• has experience navigating at least 2 of the following for their parent living with dementia: assisting the PLWD with getting a formal diagnosis of Alzheimer's disease and related dementias, finding/changing a healthcare provider, medication management, receiving treatment or having a procedure, conversations about hospice, palliative care, and/or end-of-life care.
• Past caregiver:

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Zeta Phi Beta Sorority, Inc.

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Emory Healthcare Integrated Memory Care Clinic

Atlanta, Georgia, 30329, United States

RECRUITING

Emory University Goizueta Alzheimer's Disease Research Center Minority Engagement Core

Atlanta, Georgia, 30329, United States

RECRUITING

Metro-Atlanta

Atlanta, Georgia, 30340, United States

RECRUITING

Related Publications (1)

• Bonds Johnson K, Lyons KS, Epps F, Daniel G, Monin JK, Powell W, Hepburn K. Development and evaluation of a healthcare decision-making intervention for African American parent-adult daughter dementia dyads: a mixed-methods study protocol. BMJ Open. 2025 Mar 13;15(3):e099976. doi: 10.1136/bmjopen-2025-099976.

  PMID: 40081986 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Kalisha Bonds Johnson, PhD RN PMHNP

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalisha Bonds Johnson, PhD RN PMHNP

CONTACT

404-727-5937; kbonds@emory.edu

Kenneth Hepburn

CONTACT

404.712.9286; khepbur@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 20 dyads (PLWDs and their adult daughter caregivers) will be enrolled to participate in the behavioral intervention together.

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 1, 2021
• Study Start: July 15, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: six months after publication.
• Access Criteria: Researchers will share the data with qualified researchers who complete a formal data sharing agreement for research purposes only.

Locations

US (4)