DementiaNCT05139290
DECIDE: Dyads and Families
A study testing Prototype Intervention in people with Dementia and Alzheimer Disease, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease, Caregiver Burden
- What is being tested?
- Prototype Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Jul 2022to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 23Show fewer
- self-identifies as African American
- 18 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:
- Meet criteria for caregiver except not actively providing care because of the death of their parent or the parent has been transitioned to a long-term care facility.
- The death of the parent should be at least 12 months prior to recruitment.
- Caregiver of persons with severe dementia
- Meet criteria for caregiver except actively providing care for a parent with severe dementia based on the family caregiver report on the Dementia Severity Rating Scale.
Who cannot join
- any confounding significant neurologic diseases (e.g., Parkinson's) or a major psychiatric disorder (e.g., schizophrenia).
- Caregiver:
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Healthcare Integrated Memory Care Clinic
Atlanta, Georgia, 30329
Emory University Goizueta Alzheimer's Disease Research Center Minority Engagement Core
Atlanta, Georgia, 30329
Metro-Atlanta
Atlanta, Georgia, 30340
Zeta Phi Beta Sorority, Inc.
Washington D.C., District of Columbia, 20009
About this study
Official title: Decision-Making Experiences for Culturally Inclusive Dementia Engagement: Dyads and Families (DECIDE: Dyads and Families)
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.
Read the detailed description
This is a survey/questionnaire and interview study that will examine how healthcare decisions are made for African American parents living with memory loss by African American adult daughter caregivers to develop a prototype intervention to improve how these decisions are made and improve the quality of life of African American parents living with memory loss and their African American adult daughter caregivers.
Recruitment will occur through established connections at Emory University Goizueta Alzheimer's Disease Research Center Minority Engagement Core, Emory Healthcare Integrated Memory Care Clinic, and Emory University.
Recruitment will take place in metro Atlanta and across the United States using a study flyer and video.
The flyer will include the phone number, email address of the research team, and a quick response (QR) code for potential participants to contact the research team. The video will give information about the principal investigator (PI) and the research study as a strategy to build rapport with potential participants and assuage distrust in research. Interviews will occur remotely after participants have completed the screening process and are deemed eligible for the study. This is not a no-contact study.
The data collected will be de-identified. Privacy of existing data is not a concern. This study has two phases. The first phase will consist of surveys/questionnaires and semi-structured interviews via Zoom from both the parents living with memory loss and their adult daughters as well as semi-structured interviews via Zoom of past adult daughter caregivers whose parent(s) have died or are in long-term care facilities and adult daughters caring for a parent with severe dementia only. For past adult daughter caregivers whose parents have died, the parent will need to have died at least 12 months before enrolling in the study.
In the first part of phase two (phase 2a), participants will be key informants who participate in focus group sessions using design thinking strategies to develop the prototype intervention. Key informants will consist of parent-adult daughter dyads, past adult daughter caregivers, and adult daughter caregivers of persons with severe dementia. In the last part of phase two (phase 2b), a pretest/posttest design with two follow-ups will be completed by a new set of African American parent-adult daughter dementia dyad participants. The interactions will include surveys/questionnaires and semi-structured interviews.
Data will be collected by computer/tablet and/or telephone. For participants with limited access to a computer/tablet, the surveys may be completed via paper/pencil. 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.
In phase one, surveys/questionnaires for persons with mild to moderate dementia will take 0.67 hours and 1 hour for adult daughter caregivers. In phase one, the semi-structured interviews will last 1 hour in total for both parent and daughter. Semi-structured interviews with past adult daughter caregivers and adult daughter caregivers of persons with severe dementia will last approximately 0.75 hours. In phase 2, key informants will have three sessions that last approximately 1.5 hours to assist with the development of the prototype intervention. In phase 2, the pretest/posttest surveys/questionnaire should last 0.33 hours for parents living with dementia and 0.67 hours for adult daughters at baseline and the 2 follow-ups. The last follow-up will consist of one semi-structured interview that will last about 0.5 hours.
Phase 1 will allow collecting and analyzing the necessary data to develop the prototype intervention that will be developed in Phase 2a and used in Phase 2b: the intervention phase.
- Conditions
- Dementia, Alzheimer Disease, Caregiver Burden
- Being tested
- Prototype Intervention
- Medical subject headings
- Dementia, Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prototype Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 0-month, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start15 Jul 2022 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Why it stopped: No participants were enrolled in the clinical trial portion. The community-engaged nature of the project required more time than anticipated, and funding was insufficient to support the implementation of the proposed intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 20 dyads (PLWDs and their adult daughter caregivers) will be enrolled to participate in the behavioral intervention together.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kalisha Bonds Johnson, Emory University
- Investigators
- Kalisha Bonds Johnson, PhD RN PMHNP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139290
- Sponsor's protocol ID
- STUDY00003056
- Other IDs
- 1K23AG073516-01, 2025P009644
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers will share demographic data, study measures, and outcome variables
Publications
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.
PubMed 40081986
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-Making Experiences for Culturally Inclusive Dementia Engagement: Dyads and Families (DECIDE: Dyads and Families)
- ClinicalTrials.gov ID
- NCT05139290
- Acronym / sponsor ID
- STUDY00003056
- Conditions
- Dementia, Alzheimer Disease, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the clinical trial portion. The community-engaged nature of the project required more time than anticipated, and funding was insufficient to support the implementation of the proposed intervention.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a survey/questionnaire and interview study that will examine how healthcare decisions are made for African American parents living with memory loss by African American adult daughter caregivers to develop a prototype intervention to improve how these decisions are made and improve the quality of life of African American parents living with memory loss and their African American adult daughter caregivers.
Recruitment will occur through established connections at Emory University Goizueta Alzheimer's Disease Research Center Minority Engagement Core, Emory Healthcare Integrated Memory Care Clinic, and Emory University.
Recruitment will take place in metro Atlanta and across the United States using a study flyer and video.
The flyer will include the phone number, email address of the research team, and a quick response (QR) code for potential participants to contact the research team. The video will give information about the principal investigator (PI) and the research study as a strategy to build rapport with potential participants and assuage distrust in research. Interviews will occur remotely after participants have completed the screening process and are deemed eligible for the study. This is not a no-contact study.
The data collected will be de-identified. Privacy of existing data is not a concern. This study has two phases. The first phase will consist of surveys/questionnaires and semi-structured interviews via Zoom from both the parents living with memory loss and their adult daughters as well as semi-structured interviews via Zoom of past adult daughter caregivers whose parent(s) have died or are in long-term care facilities and adult daughters caring for a parent with severe dementia only. For past adult daughter caregivers whose parents have died, the parent will need to have died at least 12 months before enrolling in the study.
In the first part of phase two (phase 2a), participants will be key informants who participate in focus group sessions using design thinking strategies to develop the prototype intervention. Key informants will consist of parent-adult daughter dyads, past adult daughter caregivers, and adult daughter caregivers of persons with severe dementia. In the last part of phase two (phase 2b), a pretest/posttest design with two follow-ups will be completed by a new set of African American parent-adult daughter dementia dyad participants. The interactions will include surveys/questionnaires and semi-structured interviews.
Data will be collected by computer/tablet and/or telephone. For participants with limited access to a computer/tablet, the surveys may be completed via paper/pencil. 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.
In phase one, surveys/questionnaires for persons with mild to moderate dementia will take 0.67 hours and 1 hour for adult daughter caregivers. In phase one, the semi-structured interviews will last 1 hour in total for both parent and daughter. Semi-structured interviews with past adult daughter caregivers and adult daughter caregivers of persons with severe dementia will last approximately 0.75 hours. In phase 2, key informants will have three sessions that last approximately 1.5 hours to assist with the development of the prototype intervention. In phase 2, the pretest/posttest surveys/questionnaire should last 0.33 hours for parents living with dementia and 0.67 hours for adult daughters at baseline and the 2 follow-ups. The last follow-up will consist of one semi-structured interview that will last about 0.5 hours.
Phase 1 will allow collecting and analyzing the necessary data to develop the prototype intervention that will be developed in Phase 2a and used in Phase 2b: the intervention phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 20 dyads (PLWDs and their adult daughter caregivers) will be enrolled to participate in the behavioral intervention together.
| Arm | Type | Receives |
|---|---|---|
| Prototype Intervention | Experimental | Behavioral: Prototype InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (2 listed)
- any confounding significant neurologic diseases (e.g., Parkinson's) or a major psychiatric disorder (e.g., schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype InterventionThe 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. | Behavioural | Prototype Intervention |
Primary outcome
Participant retention
Time frame: eight weeks
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
Usability of Intervention
Time frame: Upon completion of the intervention (estimated to be 8 weeks)
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.
Percentage of recruitment goal achieved
Time frame: Up to 6 months after the start of recruitment
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).
Change in Quality of Life-Alzheimer's Disease (QoL-AD) Scale Score
Time frame: 0-month, 1 month, 3 months
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.
Change in Decision Self-Efficacy Scale Score
Time frame: 0-month, 1 month, 3 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Derived from this study: PubMed 40081986Bonds 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.
- Individual participant dataSharing planned: Yes. Researchers will share demographic data, study measures, and outcome variables
Related trials for Dementia
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kalisha Bonds Johnson, PhD RN PMHNP principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype Intervention in people with Dementia and Alzheimer Disease, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention (time frame: eight weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05139290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.