Clinical trial NCT05849259: Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
Official title: Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Quality of Life
Caregiver Stress
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Retirement Research Foundation
First posted: 2023-05-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility for the caregiver to engage with and complete baseline assessments.
timeFrame: Baseline
measure: Feasibility for the caregiver to access educational materials and community resources.
timeFrame: Post-intervention (6 months)
measure: Feasibility for the practice of identifying potential patients/caregivers
timeFrame: Baseline
measure: Feasibility for the practice of assessing eligible patient/caregiver dyads.
timeFrame: Baseline
measure: Feasibility for the practice to use patient and caregiver assessments.
timeFrame: Post-intervention (6 months)
Secondary outcomes:
Other outcomes:
measure: Feasibility for the practice of recruiting patient/caregiver dyads
timeFrame: Post-intervention (6 months)
measure: Feasibility for the practice of percent of racial and ethnic minorities recruited.
timeFrame: Post-intervention (6 months)
measure: Feasibility for the practice to use care modules.
timeFrame: Post-intervention (6 months)
measure: Feasibility for the practice of clinicians to engage with the tele-video case conference.
timeFrame: Post-intervention (6 months)
measure: Net promoter score
timeFrame: Post-intervention (6 months)
measure: Acceptability of the intervention to caregivers and patient to participate in the intervention.
timeFrame: Post-intervention (6 months)
measure: Heard and understood
timeFrame: Pre and post intervention (prior to and 6 months after)
measure: Caregiver well-being
timeFrame: Post-intervention (6 months)
Locations:
city: Honolulu
country: United States
facility: Queens Medical Center
state: Hawaii
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: Christine S Ritchie, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Bruce Leff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Foakes 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.
citation: Yang 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.
citation: Reckrey 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.
citation: Ornstein 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.
citation: Nguyen 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.
citation: Sorensen 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.
citation: Brodaty 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.
citation: Chiao 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.
citation: Li 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.
citation: Schulz 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.
citation: Heintz 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.
citation: Tanner 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.
citation: Possin 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.
citation: Arora 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.
citation: Stammen LA, Stalmeijer RE, Paternotte E, Oudkerk Pool A, Driessen EW, Scheele F, Stassen LP. Training Physicians to Provide High-Value, Cost-Conscious Care: A Systematic Review. JAMA. 2015 Dec 8;314(22):2384-400. doi: 10.1001/jama.2015.16353.
citation: Ramsey AT, Proctor EK, Chambers DA, Garbutt JM, Malone S, Powderly WG, Bierut LJ. Designing for Accelerated Translation (DART) of Emerging Innovations in Health. J Clin Transl Sci. 2019 Jun;3(2-3):53-58. doi: 10.1017/cts.2019.386. Epub 2019 Jul 30.
citation: Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011 Jan;38(1):4-23. doi: 10.1007/s10488-010-0327-7.
citation: Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.
citation: Shih WJ, Ohman-Strickland PA, Lin Y. Analysis of pilot and early phase studies with small sample sizes. Stat Med. 2004 Jun 30;23(12):1827-42. doi: 10.1002/sim.1807.
citation: Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
citation: Krueger, RA, Casey MA. Focus groups: a practical guide for applied research. Thousand Oaks, CA: SAGE Publications, Inc.; 2000.
citation: Summit virtual meeting series: 2020 national research summit on care, services, and supports for persons with dementia and their caregivers. [Internet]. National Institute on Aging. 2020 [cited 2022 Apr 25]; Available from: https://www.nia.nih.gov/2020-dementia-care-summit
citation: Medical care at home comes of age. [Internet]. California Health Care Foundation. 2021[cited 2022 Apr 25]; Available from: https://www.chcf.org/publication/medical-care-home-comes-age/
citation: Lucero KS. Net Promoter Score (NPS): What Does Net Promoter Score Offer in the Evaluation of Continuing Medical Education? J Eur CME. 2022 Nov 29;11(1):2152941. doi: 10.1080/21614083.2022.2152941. eCollection 2022.
citation: Torisson G, Stavenow L, Minthon L, Londos E. Reliability, validity and clinical correlates of the Quality of Life in Alzheimer's disease (QoL-AD) scale in medical inpatients. Health Qual Life Outcomes. 2016 Jun 14;14:90. doi: 10.1186/s12955-016-0493-8.
citation: Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.
citation: Logsdon RG, Gibbons LE, McCurry SM, Teri L. Assessing quality of life in older adults with cognitive impairment. Psychosom Med. 2002 May-Jun;64(3):510-9. doi: 10.1097/00006842-200205000-00016.