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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Building a Bridge (BAB) Between Clinical and Community Care

Clinicaltrials.gov identifier NCT03932812

Recruitment Status Not yet recruiting

First Posted May 1, 2019

Last update posted May 3, 2019

Study Description

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:Caregiver Burden
  • Intervention/Treatment: Behavioral: Options Counselor Health Educator (OC-HE) Intervention
  • Phase: N/A
Detailed Description

Once the participant has consented, the research assistant will set up a time to complete a baseline interview, either in-person or via telephone. The baseline interview will take 40-50 minutes to complete. After the baseline survey has been completed, the participant will be randomized using simple randomization based on a computer-generated random numbers to assign the family into the intervention or standard care (control group). If the participant is randomized into the intervention group, the options counselor will be given the participant's contact information and will establish contact with the participant to make an in-home or telephone (if preferred) visit within two weeks of the participant's consent. The participant and patient can jointly participate in the initial meeting. The options counselor may make additional calls to the participant if more information is needed in the absence of the patient as requested by the participant. During the initial visit/call, the options counselor will use the modified Options Counseling (OC) assessment tool and caregiver intake form (attached) to assess patient and family needs and to develop family actions plans (see attached family action plan form) using LifeLong Links to identify services available in their local areas, and to connect them to providers. The options counselor will also provide dementia education on the topics that the family desires to discuss. Modules to discuss with the participant include About Alzheimer's Disease and Dementia, Social Relationships and Daily Life, Anticipating Changes and Challenges, Interacting with Providers, and Addressing Future Needs. This initial visit should take between 1 and 2 hours. The options counselor will conduct 5 additional follow-up intervention calls, which will last between 30 minutes to 1 hour. These calls will happen each month, in the 5 months following the initial visit/call. The follow up intervention calls will be used to adjust action plans and implement additional training modules selected by the participant. The attached intervention log will be filled out by the options counselor after each session (6 sessions per participant) to track what was covered. The research team will use the intervention logs as fidelity checks. The sessions will also be recorded so that the research team can check for fidelity to intervention protocol. The options counselor, Maria Donohoe, is a research team member on this IRB. Both intervention and standard care participants will complete 3 month and 6 month interviews, conducted by the research team members. The standard care group will have 3 and 6 month interviews prior to their receiving a call from an options counselor. The call and work that the standard care group does with an options counselor is not the intervention because the intervention protocol for this research will not be used. This phone call is made for the standard care group to receive support after the study data is collected if desired. Each follow up interview will take between 30 and 40 minutes to complete. All three interviews will be recorded so that research team members can review the data for accuracy. Participants will be asked by the research assistant for permission to record and will be invited to let the researcher know if they would not like to be recorded or if they would like to turn off the recorder at any time. Participants will still be able to participate in the study if they do not elect to be recorded. The responses questions will be recorded on paper and then entered into an online survey database on Qualtrics. Those in the intervention group wishing to continue and those in the standard care group wishing to receive Options Counseling after completing the 6 month interview will receive a call from a local options counselor in their area. Options Counseling services are provided using the Older American's Act funding by the local Area Agencies on Aging, thus, there will be no cost for older individuals and their family. . For each interview, the research assistant will make up to three calls to schedule a time, leaving a voicemail (if available) and a phone number to call if the participant would like to continue their participation. On the final call, the research assistant will let the participant know that this is the last call and if the participant would like to continue with the study, they are welcome to call back. Those who miss the 3-month follow-up interview will be contacted again for the 6-month follow up interview, and the same protocol will be used to establish contact. At the end of the study (after the 6 month follow up interview), all study participants, regardless of study arm, will be given the option to receive a call from an options counselor who will offer options counseling services in their own community.

Study Design
  • Study Type: Interventional
  • 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
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 110 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts

Contact: Lena E Thompson, MPH 319-384-1491 lena-thompson@uiowa.edu

Contact: Sato Ashida, PhD (319) 384-1477 sato-ashida@uiowa.edu

Locations

United States, Iowa
University of Iowa
Iowa City

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

Investigators

Principal Investigator: Sato Ashida, PhD University of Iowa

Principal Investigator: Kristine Williams, RN, PhD University of Kansas School of Nursing

More Information
  • Responsible Party: Sato Ashida
  • ClinicalTrials.gov Identifier: NCT03932812 History of Changes
  • Other Study ID Numbers: 201804835, 1R21AG056716-01A1
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Sato Ashida: Bridging medical settings
    Alzheimer's disease
    Dementia
    Caregiver
    Bridging community