Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04271046
Previous Study | Return to List | Next Study

STAR Caregivers - Virtual Training and Follow-up (STAR-C-VTF)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271046
Recruitment Status : Enrolling by invitation
First Posted : February 17, 2020
Last Update Posted : March 26, 2021
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of Washington
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Caregiver Burnout Behavioral: STAR-C-VTF Behavioral: Control Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The trial will use a parallel, two-arm, randomized trial design. Participants will be randomly assigned to the experimental intervention or control. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages. Everyone will complete assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: STAR Caregivers - Virtual Training and Follow-up
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Experimental Group- STAR-C-VTF

This study will use a parallel, two-arm randomized trial design. Participants will be 100 Person-with-Dementia-Caregiver dyads in which the person with dementia lives at home and recently filled a new prescription for antipsychotic medication. The experimental intervention will combine three elements:

  • self-directed learning in which the caregiver will receive training materials delivered electronically through a web-based learning portal;
  • one orientation phone visit with a coach;
  • ongoing support from the coach via telephone and secure messaging in the web-portal.

Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period.

Behavioral: STAR-C-VTF
  1. One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study and to acquaint the caregiver with the STAR-VTF components of good dementia care; distribute printed educational material (and links to same material online);
  2. Six 30-minute follow-up phone calls with the caregiver following each of the 6 learning modules to review STAR-VTF concepts, and further brainstorm strategies to modify identified activators and consequences with the objective of reducing behavioral symptoms;
  3. secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months.

Active Comparator: Control

One orientation phone visit with a coach. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages.

Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period.

Behavioral: Control
One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study. Controls will receive usual care from their primary care provider and/or psychiatrist. We will give participants an information package from the Alzheimer's Association including a list of resources. To assist with retention, and to measure responses to secure messages, we will send a template secure message to control dyads once per month in which we remind participants to contact their primary care provider if they have any issues with behavioral and psychological symptoms of dementia. Dyads in the attention control may receive information and training from their primary care provider and the Alzheimer's Association. This "attention control" is proposed to assess the additional impact of STAR-VTF above treatment as usual. Investigators do not intend to track non-study training receipt in the control arm.




Primary Outcome Measures :
  1. Change in Caregiver Burden [ Time Frame: Change from baseline caregiver burden at 8 weeks. ]
    Self-reported caregiver burden assessed by the Disruption subscale on the Revised Memory and Behavior Problem Checklist (RMBPC) questionnaire. The range in subscale scores is 0 to 32 with higher scores representing a worse outcome.

  2. Use of antipsychotic medications [ Time Frame: 6 months after initial prescription ]
    Refill rates after initial medication dispensing, using automated system pharmacy data


Secondary Outcome Measures :
  1. Change in Caregiver depression [ Time Frame: Baseline, 8 week and 6 month follow up ]

    Self-reported caregiver depression assessed by the 8-item Patient Health Questionnaire (PHQ-8).

    The PHQ-8 is am eight-item measure of depression that assesses symptoms over the last two weeks. The total sum of the 8 responses from the PHQ-8 ranges between 0 and 24 with higher scores indicating worse outcome. In general, a total of 10 or above is suggestive of the presence of depression.


  2. Change in Caregiver self-efficacy [ Time Frame: Change from baseline caregiver mastery at 8 weeks. ]

    Self-reported caregiver self-efficacy assessed by the Caregiver Mastery Scale. Total scores can range from 7 to 35, with higher scores reflecting greater caregiver mastery.

    The Caregiver Mastery Scale is a 7-item measure of self-efficacy. is a 7-item self-report scale, indicating the extent to which respondents agree (5) or disagree (1) with each item. Three items with negative statements are reverse-scored. Total scores can range from 7 to 35, with higher scores reflecting greater caregiver mastery.



Other Outcome Measures:
  1. Study Participation Rate [ Time Frame: 8 weeks from baseline ]
    We will report study participation rates by study arm at the end of training

  2. Response Rates for Surveys [ Time Frame: 8 weeks from baseline ]
    We will report survey response rates by study arm at the end of the trial.

  3. Number of Dyads Who Complete Training [ Time Frame: 8 weeks from baseline ]
    We will report completion rates by study arm at the end of the trial. Completion will be defined as completing 2 home-based visits, 1 phone-based visit and sending at least one secure message to a social worker in the baseline to 8-week period and one message in weeks 9 through 24.

  4. Number of Primary Care Visits [ Time Frame: End of follow-up (6 months) ]
    Measured as the number of visits per eligible study participant during the study period.

  5. Number of Urgent Care Visits [ Time Frame: End of follow-up (6 months) ]
    Measured as the number of visits per eligible study participant during the study period.

  6. Number of Emergency Department Visits [ Time Frame: End of follow-up (6 months) ]
    Measured as the number of visits per eligible study participant during the study period.

  7. Number of secure messages [ Time Frame: End of follow-up (6 months) ]
    Count of the number of caregiver-initiated secure messages to the coach

  8. Time per home visit [ Time Frame: baseline only ]
    Total time spent traveling to/from and conducting the home-based visit at baseline



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.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants

The investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has filled a new prescription for an antipsychotic medication. Because we will enroll dyads, there are inclusion/exclusion criteria for both.

Persons with dementia inclusion criteria:

  • Aged ≥ 65 years
  • Diagnosis of Alzheimer's Disease related dementia (ADRD)
  • A new prescription for an antipsychotic medication
  • Living at home
  • Expected to live >= 6 months from enrollment

Persons with dementia exclusion criteria:

  • A diagnosis of bipolar disorder or schizophreniform disorder
  • Living in an assisted living, skilled nursing facility, or memory facility
  • The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.

Caregiver inclusion criteria:

  • Aged ≥ 21 years
  • Lives with person with dementia or within 8 miles
  • Provides at least 8 hours of care per week

Caregivers exclusion criteria:

* Diagnosis of Alzheimer's Disease or related disorders.


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): NCT04271046


Locations
Layout table for location information
United States, Washington
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
National Institute on Aging (NIA)
University of Washington
Layout table for additonal information
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT04271046    
Other Study ID Numbers: 1347434
1R01AG061926-01 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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