DementiaNCT05849259
Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
A study testing Dementia Care Quality at Home in people with Dementia and Quality of Life, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Quality of Life, Caregiver Stress
- What is being tested?
- Dementia Care Quality at Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Caregiver participants will:
- be adults (18 years or older)
- have English fluency and literacy
- live in the United States
- live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
- anticipate providing care for the next 6 months
Show all 12Show fewer
- provide an average 4 hours of supervision or direct assistance per day for the care recipient and
- have been identified by the practice as experiencing caregiver stress.
- Staff participants will:
- be 18 years or older
- have English fluency and literacy and live in the United States and
- be part of a HBPC primary care program or closely connected to the practice.
Who cannot join
- Participants under the age 18.
- Participants who have no English fluency and literacy and do not live in the United States.
- For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Queens Medical Center
Honolulu, Hawaii, 96813
Virginia Commonwealth University
Richmond, Virginia, 23219
About this study
The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The main aims are to:
Read more
- Develop and refine HBPC Dementia Care Quality at Home
- Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention
Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.
Read the detailed description
The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.
- Conditions
- Dementia, Quality of Life, Caregiver Stress
- Being tested
- Dementia Care Quality at Home
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia Care Quality at HomeOther
Each of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) six modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Care Quality at Home | Experimental | Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention. Receives: Other: Dementia Care Quality at Home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
The percentage of identified caregivers who complete baseline assessments.
Measured: Baseline
Feasibility for the Caregiver to Access Educational Materials and Community Resources.
Percent of caregivers will report using 1 or more materials provided by the practice.
Measured: Post-intervention (6 months)
Feasibility for the Practice of Identifying Potential Patients/Caregivers
Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice
Measured: Baseline
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.
Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).
Measured: Baseline
Feasibility for the Practice to Use Baseline Assessments.
Percent of practice personnel who conduct assessments that rate assessments as feasible to use
Measured: Post-intervention (6 months)
Feasibility for the Practice to Complete Baseline Assessments
The percent of audited assessments that are completed.
Measured: Post-intervention (6 months)
Secondary outcomes (9)
Feasibility for the Practice of Recruiting Patient/Caregiver Dyads
Percentage of eligible dyads who enroll.
Measured: Pre-intervention
Patient Quality of Life
Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Measured: Pre-Intervention (baseline) and post-intervention (6 months)
Heard and Understood
A one-item measure of caregivers who report that they felt heard and understood by the practice.
Measured: Post Intervention (6 months)
Caregivers - Net Promoter Score of Intervention
The single question - "How likely are you to recommend X to a friend [or colleague]?" is rated from 0 - Not at all likely to 10 - Extremely likely.
Measured: Post-intervention (6 months)
Feasibility for the Practice to Use Care Modules.
The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use
Measured: Post-intervention (6 months)
Feasibility for the Practice to Complete Care Modules
Percent of audited modules that are completed.
Measured: Post Intervention (6-months)
Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.
% of case conferences conducted with at least one staff member present from each site
Measured: Post-intervention (6 months)
Acceptability of the Intervention to Caregivers to Participate in the Intervention.
Percent of caregivers invited to participate who agree to participate in the intervention.
Measured: Pre-intervention (baseline)
Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.
Percentage of eligible dyads who enroll who are racial and ethnic minorities.
Measured: Pre-intervention (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start16 Oct 2023
- Primary completion31 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Principal investigator, Christine S. Ritchie, MD, MPH, Massachusetts General Hospital
- Investigators
- Christine S Ritchie, MD, MSPH, Principal investigator, Massachusetts General HospitalBruce Leff, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849259
- Sponsor's protocol ID
- 2022P003057
- Status last verified
- Sep 2025
- First submitted
- 7 Apr 2023
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leff B, Ritchie C, Freeland DG, Jamshed N, Major A, Gallopyn N, Sharieff S, Taylor J, Yudin JA, Sheehan OC. The National Home-Based Primary Care Learning Network: A Practice-Based Quality Improvement and Research Network. J Am Med Dir Assoc. 2022 Aug;23(8):1424-1426. doi: 10.1016/j.jamda.2022.02.017. Epub 2022 Mar 26.
PubMed 35351444Foakes G, Hurt C, Lehner JL, Tinsley H, Valentine J, Doede DD, Ritchie C, Leff B. Using Registry Data to Support National Quality Forum Endorsement of Quality Measures for Home-Based Medical Care. Am J Med Qual. 2021 Nov-Dec 01;36(6):402-407. doi: 10.1097/01.JMQ.0000735496.32223.40.
PubMed 33990472Yang M, Pajewski N, Espeland M, Easterling D, Williamson JD. Modifiable risk factors for homebound progression among those with and without dementia in a longitudinal survey of community-dwelling older adults. BMC Geriatr. 2021 Oct 18;21(1):561. doi: 10.1186/s12877-021-02506-1.
PubMed 34663232Reckrey JM, Yang M, Kinosian B, Bollens-Lund E, Leff B, Ritchie C, Ornstein K. Receipt Of Home-Based Medical Care Among Older Beneficiaries Enrolled In Fee-For-Service Medicare. Health Aff (Millwood). 2020 Aug;39(8):1289-1296. doi: 10.1377/hlthaff.2019.01537.
PubMed 32744949Ornstein KA, Leff B, Covinsky KE, Ritchie CS, Federman AD, Roberts L, Kelley AS, Siu AL, Szanton SL. Epidemiology of the Homebound Population in the United States. JAMA Intern Med. 2015 Jul;175(7):1180-6. doi: 10.1001/jamainternmed.2015.1849.
PubMed 26010119Nguyen HQ, Vallejo JD, Macias M, Shiffman MG, Rosen R, Mowry V, Omotunde O, Hong B, Liu IA, Borson S. A mixed-methods evaluation of home-based primary care in dementia within an integrated system. J Am Geriatr Soc. 2022 Apr;70(4):1136-1146. doi: 10.1111/jgs.17627. Epub 2021 Dec 22.
PubMed 34936090Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available.
PubMed 21502853Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
PubMed 19585957Chiao CY, Wu HS, Hsiao CY. Caregiver burden for informal caregivers of patients with dementia: A systematic review. Int Nurs Rev. 2015 Sep;62(3):340-50. doi: 10.1111/inr.12194. Epub 2015 Jun 8.
PubMed 26058542Li L, Wister AV, Mitchell B. Social Isolation Among Spousal and Adult-Child Caregivers: Findings From the Canadian Longitudinal Study on Aging. J Gerontol B Psychol Sci Soc Sci. 2021 Aug 13;76(7):1415-1429. doi: 10.1093/geronb/gbaa197.
PubMed 33170276Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. doi: 10.1093/geront/35.6.771.
PubMed 8557205Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging Collaborative Care Models for Dementia Care in the Primary Care Setting: A Narrative Review. Am J Geriatr Psychiatry. 2020 Mar;28(3):320-330. doi: 10.1016/j.jagp.2019.07.015. Epub 2019 Aug 2.
PubMed 31466897Tanner JA, Black BS, Johnston D, Hess E, Leoutsakos JM, Gitlin LN, Rabins PV, Lyketsos CG, Samus QM. A randomized controlled trial of a community-based dementia care coordination intervention: effects of MIND at Home on caregiver outcomes. Am J Geriatr Psychiatry. 2015 Apr;23(4):391-402. doi: 10.1016/j.jagp.2014.08.002. Epub 2014 Aug 13.
PubMed 25260557Possin KL, Merrilees JJ, Dulaney S, Bonasera SJ, Chiong W, Lee K, Hooper SM, Allen IE, Braley T, Bernstein A, Rosa TD, Harrison K, Begert-Hellings H, Kornak J, Kahn JG, Naasan G, Lanata S, Clark AM, Chodos A, Gearhart R, Ritchie C, Miller BL. Effect of Collaborative Dementia Care via Telephone and Internet on Quality of Life, Caregiver Well-being, and Health Care Use: The Care Ecosystem Randomized Clinical Trial. JAMA Intern Med. 2019 Dec 1;179(12):1658-1667. doi: 10.1001/jamainternmed.2019.4101.
PubMed 31566651Arora S, Thornton K, Murata G, Deming P, Kalishman S, Dion D, Parish B, Burke T, Pak W, Dunkelberg J, Kistin M, Brown J, Jenkusky S, Komaromy M, Qualls C. Outcomes of treatment for hepatitis C virus infection by primary care providers. N Engl J Med. 2011 Jun 9;364(23):2199-207. doi: 10.1056/NEJMoa1009370. Epub 2011 Jun 1.
PubMed 21631316
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
- ClinicalTrials.gov ID
- NCT05849259
- Acronym / sponsor ID
- 2022P003057
- Conditions
- Dementia, Quality of Life, Caregiver Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The main aims are to:
- Develop and refine HBPC Dementia Care Quality at Home
- Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention
Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.
Detailed description
The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.
The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.
| Arm | Type | Receives |
|---|---|---|
| Dementia Care Quality at Home | Experimental | Other: Dementia Care Quality at HomeCaregivers across two HBPC practices receive the Dementia Care Quality at Home intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- be adults (18 years or older)
- have English fluency and literacy
- live in the United States
- live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
- anticipate providing care for the next 6 months
Key exclusion criteria (3 listed)
- Participants under the age 18.
- Participants who have no English fluency and literacy and do not live in the United States.
- For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.
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 |
|---|---|---|
| Dementia Care Quality at HomeEach of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) six modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges. | Other | Dementia Care Quality at Home |
Primary outcome
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
Time frame: Baseline
The percentage of identified caregivers who complete baseline assessments.
Feasibility for the Caregiver to Access Educational Materials and Community Resources.
Time frame: Post-intervention (6 months)
Percent of caregivers will report using 1 or more materials provided by the practice.
Feasibility for the Practice of Identifying Potential Patients/Caregivers
Time frame: Baseline
Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.
Time frame: Baseline
Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).
Feasibility for the Practice to Use Baseline Assessments.
Time frame: Post-intervention (6 months)
Percent of practice personnel who conduct assessments that rate assessments as feasible to use
Feasibility for the Practice to Complete Baseline Assessments
Time frame: Post-intervention (6 months)
The percent of audited assessments that are completed.
9 secondary outcomes
Feasibility for the Practice of Recruiting Patient/Caregiver Dyads
Time frame: Pre-intervention
Patient Quality of Life
Time frame: Pre-Intervention (baseline) and post-intervention (6 months)
Heard and Understood
Time frame: Post Intervention (6 months)
Caregivers - Net Promoter Score of Intervention
Time frame: Post-intervention (6 months)
Feasibility for the Practice to Use Care Modules.
Time frame: Post-intervention (6 months)
Feasibility for the Practice to Complete Care Modules
Time frame: Post Intervention (6-months)
Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.
Time frame: Post-intervention (6 months)
Acceptability of the Intervention to Caregivers to Participate in the Intervention.
Time frame: Pre-intervention (baseline)
Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.
Time frame: Pre-intervention (baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35351444Leff B, Ritchie C, Freeland DG, Jamshed N, Major A, Gallopyn N, Sharieff S, Taylor J, Yudin JA, Sheehan OC. The National Home-Based Primary Care Learning Network: A Practice-Based Quality Improvement and Research Network. J Am Med Dir Assoc. 2022 Aug;23(8):1424-1426. doi: 10.1016/j.jamda.2022.02.017. Epub 2022 Mar 26.
- Background: PubMed 33990472Foakes G, Hurt C, Lehner JL, Tinsley H, Valentine J, Doede DD, Ritchie C, Leff B. Using Registry Data to Support National Quality Forum Endorsement of Quality Measures for Home-Based Medical Care. Am J Med Qual. 2021 Nov-Dec 01;36(6):402-407. doi: 10.1097/01.JMQ.0000735496.32223.40.
- Background: PubMed 34663232Yang M, Pajewski N, Espeland M, Easterling D, Williamson JD. Modifiable risk factors for homebound progression among those with and without dementia in a longitudinal survey of community-dwelling older adults. BMC Geriatr. 2021 Oct 18;21(1):561. doi: 10.1186/s12877-021-02506-1.
- Background: PubMed 32744949Reckrey JM, Yang M, Kinosian B, Bollens-Lund E, Leff B, Ritchie C, Ornstein K. Receipt Of Home-Based Medical Care Among Older Beneficiaries Enrolled In Fee-For-Service Medicare. Health Aff (Millwood). 2020 Aug;39(8):1289-1296. doi: 10.1377/hlthaff.2019.01537.
- Background: PubMed 26010119Ornstein KA, Leff B, Covinsky KE, Ritchie CS, Federman AD, Roberts L, Kelley AS, Siu AL, Szanton SL. Epidemiology of the Homebound Population in the United States. JAMA Intern Med. 2015 Jul;175(7):1180-6. doi: 10.1001/jamainternmed.2015.1849.
- Background: PubMed 34936090Nguyen HQ, Vallejo JD, Macias M, Shiffman MG, Rosen R, Mowry V, Omotunde O, Hong B, Liu IA, Borson S. A mixed-methods evaluation of home-based primary care in dementia within an integrated system. J Am Geriatr Soc. 2022 Apr;70(4):1136-1146. doi: 10.1111/jgs.17627. Epub 2021 Dec 22.
- Background: PubMed 21502853Sorensen S, Conwell Y. Issues in dementia caregiving: effects on mental and physical health, intervention strategies, and research needs. Am J Geriatr Psychiatry. 2011 Jun;19(6):491-6. doi: 10.1097/JGP.0b013e31821c0e6e. No abstract available.
- Background: PubMed 19585957Brodaty H, Donkin M. Family caregivers of people with dementia. Dialogues Clin Neurosci. 2009;11(2):217-28. doi: 10.31887/DCNS.2009.11.2/hbrodaty.
- Background: PubMed 26058542Chiao CY, Wu HS, Hsiao CY. Caregiver burden for informal caregivers of patients with dementia: A systematic review. Int Nurs Rev. 2015 Sep;62(3):340-50. doi: 10.1111/inr.12194. Epub 2015 Jun 8.
- Background: PubMed 33170276Li L, Wister AV, Mitchell B. Social Isolation Among Spousal and Adult-Child Caregivers: Findings From the Canadian Longitudinal Study on Aging. J Gerontol B Psychol Sci Soc Sci. 2021 Aug 13;76(7):1415-1429. doi: 10.1093/geronb/gbaa197.
- Background: PubMed 8557205Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. doi: 10.1093/geront/35.6.771.
- Background: PubMed 31466897Heintz H, Monette P, Epstein-Lubow G, Smith L, Rowlett S, Forester BP. Emerging Collaborative Care Models for Dementia Care in the Primary Care Setting: A Narrative Review. Am J Geriatr Psychiatry. 2020 Mar;28(3):320-330. doi: 10.1016/j.jagp.2019.07.015. Epub 2019 Aug 2.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer 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.
Christine S Ritchie, MD, MSPH principal investigator
Massachusetts General Hospital
Bruce Leff, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia Care Quality at Home in people with Dementia and Quality of Life, run by Massachusetts General Hospital at 2 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 12 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments. (time frame: Baseline). The study lists 6 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 NCT05849259, which also lists 32 linked publications.
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 25 Sep 2025.