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Trial record 8 of 186 for:    "social welfare" | Recruiting, Not yet recruiting Studies

Utilizing Senior Companions to Enhance Dementia Care

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ClinicalTrials.gov Identifier: NCT03667924
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
Lutheran Social Services of Minnesota
Johns Hopkins University
Brown University
University of Texas-Arlington
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The inability of healthcare systems to effectively manage Alzheimer's disease and related dementias (ADRD) often results in families remaining unaware of important community-based, long-term services and supports (LTSS) that could help to mitigate the negative effects of cognitive impairment. This project will feature a collaboration between Lutheran Social Service of Minnesota and the University of Minnesota to evaluate a novel adaption of the volunteer Senior Companion Program (SCP) to: a) assist families better manage ADRD at home; b) identify and facilitate the use of LTSS; and c) improve engagement with primary care providers throughout the state of Minnesota. If successful, the SCP-Dementia will offer a potentially efficient, wide-ranging service model for states and communities to implement for persons with ADRD and their caregiving families.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Behavioral: Senior-Companion Dementia Group Phase 2

Detailed Description:

This R61 project will evaluate a novel adaption of the Senior Companion Program (SCP) administered by Lutheran Social Service of Minnesota to assist families better manage their relatives' Alzheimer's disease or related dementias (ADRDs); identify and facilitate use of community-based long-term services and supports (LTSS); and improve engagement with healthcare providers. This intervention, called the SCP-Dementia (SCP-D) has the following aims):

1. Implement SCP-D for 25 persons with ADRD or memory concerns in one urban and rural region of Minnesota. A convergent parallel mixed methods design [(QUAN+QUAL)-->QUAL] will be utilized to examine the feasibility, acceptability, and utility of SCP-D for 25 families and their SC-Ds (n = 20) over a 3-month period (i.e., Stage I of the NIH Stage Model).

Specific Aim 2. Refine SCP-D delivery and implementation for efficacy evaluation. Activities to support this aim will include assessment of R61 milestones and incorporation of R61 findings to refine the SCP-D prior to efficacy evaluation. Through stakeholder engagement with the Dementia Healthcare Research Advisory Group (DHR) as well as analysis of the various quantitative and qualitative data elements collected during this Phase, the investigators will finalize and refine effective training approaches for SCP-D Companions (SC-D), identify and confirm stakeholder-centric measures, and enhance the overall implementation of the SCP-D to inform a subsequent R33 Phase.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilizing Senior Companions to Enhance Dementia Care Services and Supports
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Senior Companion-Dementia Group
Participants in the Senior Companion-Dementia group will receive home-based support and respite services from Senior Companion-Dementia trained volunteers of the Lutheran Social Services of Minnesota.
Behavioral: Senior-Companion Dementia Group
Senior Companions who deliver the Senior Companion-Dementia (SCP-D) (i.e., SC-Ds) will complete the online CARES® Dementia Care Specialist training modules, ongoing monthly case review and discussions as overseen by the University of Minnesota (UMN) research team (the Principal Investigator/PI, research coordinator) and Lutheran Social Services of Minnesota, and receive an adapted lay person training module. Senior Companions who deliver the SCP-D will also be trained to identify community-based LTSS. The adapted SC-D training via monthly web/teleconference sessions will occur in Months 5-7. Following training, the monthly web/teleconference sessions will largely focus on review of specific cases, discussion of challenges and potential solutions, provision of additional education as needed, and ensuring that SC-Ds are regularly engaged with persons with ADRD and family members throughout SCP-D delivery.




Primary Outcome Measures :
  1. Change in the frequency of service utilization for person with ADRD [ Time Frame: Baseline, 1-month, 3-month ]
    Community-based service utilization of persons with ADRD will be assessed by asking family caregivers to identify (from a fixed list of options) fifteen different home and community-based services (HCBS). This is a "yes/no" checklist and is summed to create a total score: the higher the score, the more services used.


Secondary Outcome Measures :
  1. Change in perceived quality of primary care provider interactions [ Time Frame: Baseline, 1-month, 3-month ]
    A 19-item "yes/no" measure of quality of interaction during encounters with primary care providers will be administered to respondents. A total score is created by summing the item responses, with greater scores equaling greater perceived quality in primary care provider interactions.

  2. Change in perceived caregiver burden [ Time Frame: Baseline, 1-month, 3-month ]
    The 22-item Zarit Burden Interview self-report survey measure. Item responses range from 0 "never" to 4 "nearly always." Scores are summed and can range from a score of 0 (no burden) to 88 (high burden).

  3. Change in frequency and perceived intensity of respondent depressive symptoms [ Time Frame: Baseline, 1-month, 3-month ]
    The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms. Item responses range from 1 = "Rarely or none of the time (less than 1 day)" to 5 = "Most of the time (5-7 days)." The total CES-D score is summed, with a range of 20 (little to no depressive symptoms) to 100 (frequent depressive symptoms).

  4. Change in person's wtih ADRD perceived well-being [ Time Frame: Baseline, 1-month, 3-month ]
    We will assess the person with ADRDs health related quality of life using the EQ-5D-5L and the Health Utilities Index 2/3 (HUI). For both the EQ-5D-5L and HUI caregivers will serve as proxies and these measures will be used to generate the person with ADRDs health utility that will inform the cost-effectiveness analysis. Total scores are sums of the various item-responses; the higher the score, the greater the well-being.

  5. Change in perceived caregiver self-efficacy [ Time Frame: Baseline, 1-month, 3-month ]
    An 8-item survey measure of caregiver self-efficacy. Item responses range from 1 "very unconfident" to 5 "very confident." Scores are summed and can range from a score of 1 (low self-efficacy) to 40 (high self-efficacy).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The person has a physician diagnosis of ADRD or answers yes to the question "I or others (family members, friends, healthcare professionals) are concerned about my memory loss" (this question is included as it is possible many persons with potential dementia and their family members in underserved communities, such as rural areas, may not have easy access to formal diagnostic services);
  • The family member self-identifies as someone who provides help to the person with ADRD because of their cognitive impairments, if a family member is available.

Exclusion Criteria:

- Those who do not meet the inclusion criteria above.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667924


Contacts
Contact: Joseph E. Gaugler, PhD 612-626-2485 gaug0015@umn.edu
Contact: Amanda Weinstein, MS 612-626-9535 weins064@umn.edu

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Lutheran Social Services of Minnesota
Johns Hopkins University
Brown University
University of Texas-Arlington

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03667924     History of Changes
Other Study ID Numbers: R61AG061903 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Caregiving
Community-based care
Long-term services and supports
Volunteer

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders