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Building a Bridge (BAB) Between Clinical and Community Care (BAB)

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. Identifier: NCT03932812
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 3, 2019
National Institute on Aging (NIA)
University of Kansas School of Nursing
University of Michigan
Boston College
Drexel University Dornsife School of Public Health
Information provided by (Responsible Party):
Sato Ashida, University of Iowa

Brief Summary:
Dementia diagnosis triggers a transitional phase for the individuals and their families, often causing emotional distress and family conflicts due to the ambiguity of the illness and future trajectories. Families often report a lack of information and guidance during the period immediately following diagnosis, suggesting a missed opportunity for prevention of family distress at the outset of the caregiver and patient career. With large and increasing numbers of individuals newly diagnosed with Alzheimer's Disease and Related Dementias (ADRD) each year, there is an urgent need to develop effective intervention models to support role transitions and minimize distress related to ADRD diagnosis. The long-term goal of this research is to minimize negative consequences of ADRD by enhancing the support systems of the affected families as they start their new and challenging phase of life as patients and family caregivers. The aim of this research is to evaluate the impact of this new Options Counselor-Health Education (OC-HE) intervention on bridging the medical and community-settings through potential mechanisms of influence, enhancement of social networks and support. Implementation strategies will be developed in collaboration with partnering clinics and local Area Agencies on Aging. Participants will be recruited from three clinics at the University of Iowa Hospitals and Clinics (UIHC) that provide dementia diagnostic services and randomized into an intervention or control arm; and complete baseline and three- and six-month follow-up interviews. This study is innovative in its consideration of contributing factors at multiple levels of the ecological model (i.e., individual, social network, and organizational) and its collaborative approach, involving medical clinics, an Area Agency on Aging (AAA), and Alzheimer's Association (AA) to develop and evaluate a new care model that bridges between the medical and community settings.

Condition or disease Intervention/treatment Phase
Caregiver Burden Behavioral: Options Counselor Health Educator (OC-HE) Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Building a Bridge (Between Clinical and Community Care): Post-diagnosis Support for Persons With Dementia and Their Families
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Options Counselor Health Educator Intervention Group
These individuals will receive the Options Counselor Health Educator Intervention
Behavioral: Options Counselor Health Educator (OC-HE) Intervention
The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team

No Intervention: Control
These individuals will receive the typical standard of care treatment from clinics

Primary Outcome Measures :
  1. Modified Zarit Burden Interview [ Time Frame: Change from baseline at 6-months ]
    Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden

Secondary Outcome Measures :
  1. Knowledge of formal services [ Time Frame: Change from baseline at 6-months ]
    Established measure of the extent to which caregiver knows about formal services available in their communities. Participants answer the extent to which (on a five-point Likert scale from "not at all true of me" to "completely true of me") they are informed about federal programs, that they know what to do to get help, that they know how to get the person they care for into a nursing home, that they are aware of how to pay for a nursing home, that they can get information about different options for getting care, that they know which home health care agencies are active in their area, and that they know which assisted living or nursing facilities are available in their area. There are seven questions. Seven questions answered "Not at all true of me" shows the least knowledge of formal services, seven questions answered "Completely true of me" is the highest amount of knowledge of formal services.

  2. Center for Epidemiologic Studies Depression [ Time Frame: Change from baseline at 6-months ]
    Ten item measure assessing the extent to which the individual is experiencing depressive symptoms. Questions as about how often feelings or events happen in a week on a scale from None of the time, where less than one day receives 0 points, to Most of the time, where 5 to 7 days receives 3 points. The lowest score is a 0, indicating no depression. The highest score is 30, indicating high depression.

  3. hospital and emergency care use [ Time Frame: Change from baseline at 6-months ]
    Self-reported measure of the number of times participants have visited a doctor or other health care provider and the number of times the participant has been hospitalized overnight in the past 6 months. The lowest score could be 0, indicating no hospital or emergency care use and the highest score for each could be 180 days, indicating that the participant visited a doctor or health care provider or has been hospitalized overnight every day for the past six months

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 to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years of age
  • Speaks English
  • Lives in Iowa
  • Caregiver of someone diagnosed with dementia within the past 6 months

Exclusion Criteria:

- Does not meet inclusion criteria

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 identifier (NCT number): NCT03932812

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Contact: Lena E Thompson, MPH 319-384-1491
Contact: Sato Ashida, PhD (319) 384-1477

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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Contact: Lena Thompson, MPH    319-384-1491   
Contact: Sato Ashida, PhD    319-384-1477   
Principal Investigator: Sato Ashida, PhD         
Sub-Investigator: Kristine Williams, RN, PhD         
Sponsors and Collaborators
Sato Ashida
National Institute on Aging (NIA)
University of Kansas School of Nursing
University of Michigan
Boston College
Drexel University Dornsife School of Public Health
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Principal Investigator: Sato Ashida, PhD University of Iowa
Principal Investigator: Kristine Williams, RN, PhD University of Kansas School of Nursing

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Responsible Party: Sato Ashida, Associate Professor, University of Iowa Identifier: NCT03932812    
Other Study ID Numbers: 201804835
1R21AG056716-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sato Ashida, University of Iowa:
Alzheimer's disease
Bridging community
Bridging medical settings