Building a Bridge (BAB) Between Clinical and Community Care

NCT ID: NCT03932812

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-10-31

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.

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.

Conditions

Caregiver Burden

Keywords

Alzheimer's disease; Dementia; Caregiver; Bridging community; Bridging medical settings

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Options Counselor Health Educator Intervention Group

These individuals will receive the Options Counselor Health Educator Intervention

Group Type: EXPERIMENTAL

Options Counselor Health Educator (OC-HE) Intervention

Intervention Type: BEHAVIORAL

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

Control

These individuals will receive the typical standard of care treatment from clinics

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

Boston College

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: collaborator

Sato Ashida

OTHER

Sponsor Role: lead

Responsible Party

Sato Ashida

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sato Ashida, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Kristine Williams, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

Ashida S, Lynn FB, Thompson L, Koehly LM, Williams KN, Donohoe MS. Using Clustering Methods to Map the Experience Profiles of Dementia Caregivers. Innov Aging. 2024 May 18;8(6):igae046. doi: 10.1093/geroni/igae046. eCollection 2024.

Reference Type: DERIVED

PMID: 38859822 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R21AG056716-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201804835

Identifier Type: -

Identifier Source: org_study_id