Building a Bridge (BAB) Between Clinical and Community Care

NCT03932812 | Completed Results DMC

• 2 other identifiers: 2018048351R21AG056716-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Modified Zarit Burden Interview

  Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden

  Change over time from baseline to 6-month

Secondary Outcomes (5)

• Knowledge of Formal Services

  Change over time from baseline to 6-month

• Center for Epidemiologic Studies Depression

  Change over time from baseline to 6-month

• Emergency Care Use

  Change over time from baseline to 6-month

• Social Network-Uplift

  Change over time from baseline to 6-month

• Social Network-Malfeasant

  Change over time from baseline to 6-month

Other Outcomes (1)

• Caregiving Self-Efficacy

  Change over time from baseline to 6-month

Study Arms (2)

Options Counselor Health Educator Intervention Group

EXPERIMENTAL

These individuals will receive the Options Counselor Health Educator Intervention

Behavioral: Options Counselor Health Educator (OC-HE) Intervention

Control

NO INTERVENTION

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

Interventions

Options Counselor Health Educator (OC-HE) Intervention 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

Options Counselor Health Educator Intervention Group

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Sato Ashida: lead
• National Institute on Aging (NIA): collaborator
• University of Kansas: collaborator
• University of Michigan: collaborator
• Boston College: collaborator
• Drexel University: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Rezende EL, Silva-Duran I I, Fernando Novoa F, Rosenmann M. Does thermal history affect metabolic plasticity?: a study in three Phyllotis species along an altitudinal gradient. J Therm Biol. 2001 Apr;26(2):103-108. doi: 10.1016/s0306-4565(00)00029-2.

  PMID: 11163925 RESULT

• 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.

  PMID: 38859822 DERIVED

MeSH Terms

Conditions

Caregiver Burden; Alzheimer Disease; Dementia

Interventions

Methods

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Limitations and Caveats

This intervention trial was greatly affected by the COVID-19 pandemic resulting in small number of participants and modifications in recruitment and intervention delivery. Furthermore, it is hypothesized that this impact reduces power to detect the impact of the intervention. The impact of the pandemic was not accounted for in the statistical analyses while missing data may have occurred due to the pandemic.

Results Point of Contact

• Title: Sato Ashida
• Organization: University of Iowa

sato-ashida@uiowa.edu

319-384-1477

Study Officials

• Sato Ashida, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Kristine Williams, RN, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 1, 2019
• Study Start: August 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 19, 2025
• Results First Posted: December 16, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)