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The STELLA Collaborative: Using Technology to Advance ADRD Family Education and Support (STELLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335110
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Allison Lindauer, Oregon Health and Science University

Brief Summary:
STELLA (Support via Technology Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent video-conference based intervention that aims to help family members caring for persons of dementia as well the person with dementia. The goal of this intervention is to reduce upsetting behaviors and care partner burden. Caring for a family member with Alzheimer's disease or related dementia (ADRD) can come with many burdens that affect not only the care partners' physical and psychological health but also barriers to access. Due to factors such as distance and cost, Internet-based interventions like STELLA are a great alternative to in-person interventions because it can still address the specific needs of families living with dementia. The hypothesis of this study is that care partners will show significant improvements in burden and depression following the intervention. STELLA is also designed to facilitate effective management of behavioral and psychological symptoms of dementia (BPSD). To accomplish this, up to 40 care partners and their 40 care recipients with Alzheimer's disease and related dementias will participate in an 8-week intervention with the support of a Guide (e.g. nurse or social worker). However, the primary focus of this study is on care partners. With the support of a Guide, care partners will identify strategies to address upsetting behaviors in the moderate to late stages of dementia. More specifically, a Guide will help care partners identify and modify distressing behavioral symptoms of dementia. Based on quantitative and qualitative approaches, the effect of the intervention on care partner affective symptoms, including depression and burden, as well as quality of life for both the care partner and the person with dementia will be assessed.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Caregiver Burnout Family Members Behavioral: STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The STELLA Collaborative: Using Technology to Advance ADRD Family Education and Support
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention
Care Partners and Persons with Dementia. Up to 40 Care Partners and their 40 care-recipients with ADRD will participate in this study. The primary focus of this study is on Care Partners, however, we will gather subjective and objective data on participants with Alzheimer's Disease and Related Dementias (ADRD) to assess the effect of the intervention on Care Partner affective responses to caregiving and quality of life for both. STELLA participants will be recruited from the existing cohort of patients, and their Care Partners, who are enrolled in the Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology) ORCASTRAIT Life Laboratory (OSLL).
Behavioral: STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias)
STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small group will include as few as two and as many as 4 Care Partners) Each weekly session takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's and the Care Partner's) which are upsetting to the family. Care Partners will be taught to use an Activator, Behavior, Consequence (ABC) approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After they identify the ABCs, they will develop a plan to address the behavior and then test it. After the four one-to-one sessions, Care Partners will meet in small groups with a Guide. Effective communication strategies, engagement in pleasant events, and coping will be addressed.




Primary Outcome Measures :
  1. Revised Memory and Behavior Problems Checklist [ Time Frame: 1 year ]
    Care partner difficulty in managing behavioral symptoms of dementia

  2. Marwit Meuser Caregiver Grief Index [ Time Frame: 1 year ]
    Care partner anticipatory grief

  3. Desire to Institutionalize (DTI) scale [ Time Frame: 1 year ]
    Care partner intention to place person with dementia in care facility

  4. Center for Epidemiological Studies Depression Scale [ Time Frame: 1 year ]
    Care partner depression


Secondary Outcome Measures :
  1. Feasibility and participant acceptability [ Time Frame: 1 year ]
    Measurement of participant retention and qualitative data collection via surveys and focus groups

  2. Quality of life in Alzheimer's Disease (QOL-AD) scale [ Time Frame: 1 year ]
    Quality of life for person with dementia

  3. Time together and alone [ Time Frame: 1 year ]
    Digital behavioral biomarker for effective impact of care on care partner activity

  4. Sleep duration [ Time Frame: 1 year ]
    Digital behavioral biomarker for effective impact of care on care partner sleep



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Care Recipient Inclusion:

  • Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), moderate to late stages
  • Exhibits 2 or more behaviors listed on Revised Memory and Behavioral Problems (RMBP) that are bothersome to the Care Partner and occur 3 or more times/week at study enrollment
  • Family member of Care Partner (this can be a relative, spouse or close kin that is considered family)

Care Recipient Exclusion:

  • Dementia not related to ADRD
  • Unable to leave Care Partner during Care Partner training
  • Early stage dementia, as defined by a Montreal Cognitive Assessment (MoCA) of about 15/30 or higher.

Care Partner Inclusion:

  • Adult caring for family member with ADRD
  • Lives with care recipient OR spends at least 4 hours/week with care recipient
  • Age of 18 years or older
  • Speak English
  • Own a computer/device with a reliable internet connection and compatible operating system

Care Partner Exclusion:

  • Unable to find activity for care recipient during training which would allow Care Partner to work privately, one-on-one during training
  • Completed similar telehealth intervention within the last year
  • Hearing and vision problems severe enough to prevent participation
  • Unwilling or unable to adequately follow study instructions and participate in study procedures

Inclusion for Care Recipient and Care Partner:

Participate in Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology (ORCASTRAIT) (IRB#20236) Participant in the ORCASTRAIT study (IRB # 20236)


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): NCT04335110


Contacts
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Contact: Allison Lindauer, PhD 503-494-6976 lindauer@ohsu.edu

Locations
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United States, Oregon
Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center Recruiting
Portland, Oregon, United States, 97239
Contact: Allison Lindauer, PhD    503-494-6976    lindauer@ohsu.edu   
Principal Investigator: Allison Lindauer, PhD         
Sponsors and Collaborators
Oregon Health and Science University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Allison Lindauer, PhD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Allison Lindauer, Oregon Health and Science University:
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Responsible Party: Allison Lindauer, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT04335110    
Other Study ID Numbers: STUDY00019306
2P30AG024978-16 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be available upon request to our Alzheimer's Disease Research Center.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be available 1/2021, available indefinitely
Access Criteria: Requests need to made to the PI at the Oregon Alzheimer's Disease Research Center (OARDC). A short data request form will need to be submitted to the OADRC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Burnout, Psychological
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Stress, Psychological
Behavioral Symptoms