Caregiver BurdenBABNCT03932812
Building a Bridge (BAB) Between Clinical and Community Care
A study testing Options Counselor Health Educator (OC-HE) Intervention in people with Caregiver Burden, run by Sato Ashida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Options Counselor Health Educator (OC-HE) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Speaks English
- Lives in Iowa
- Caregiver of someone diagnosed with dementia within the past 6 months
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building a Bridge (Between Clinical and Community Care): Post-diagnosis Support for Persons With Dementia and Their Families
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.
Read the 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
- Being tested
- Options Counselor Health Educator (OC-HE) Intervention
- Keywords
- Alzheimer's disease, Dementia, Caregiver, Bridging community, Bridging medical settings
- Medical subject headings
- Caregiver Burden, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Options Counselor Health Educator (OC-HE) InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Options Counselor Health Educator Intervention Group | Experimental | These individuals will receive the Options Counselor Health Educator Intervention Receives: Behavioral: Options Counselor Health Educator (OC-HE) Intervention |
| Control | No intervention | These individuals will receive the typical standard of care treatment from clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Zarit Burden Interview
Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden
Measured: Change over time from baseline to 6-month
Secondary outcomes (5)
Knowledge of Formal Services
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, that they know which nursing facilities are available in their area, and how to get assistance due to COVID (added later). The scale ranges from "Not True at all of me" to "Completely true of me", where these answers and those in between score 1-5. The scale is scored by adding up these scores of the 8 questions. Thus, the range is 8-40, with a 40 being the highest knowledge of formal services.
Measured: Change over time from baseline to 6-month
Center for Epidemiologic Studies Depression
Ten item measure assessing the extent to which the individual is experiencing depressive symptoms. Questions ask 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.
Measured: Change over time from baseline to 6-month
Emergency Care Use
Self-reported measure of the number of times participants have visited a doctor or other health care provider unexpectedly in the past 6 months. The lowest score could be 0, indicating no emergency care use and the highest score for each could be 180 days, indicating that the participant visited a doctor or health care provider every day for the past six months
Measured: Change over time from baseline to 6-month
Social Network-Uplift
Count of network members engaging in supportive interactions (Uplift) for each caregiver. Each caregiver had network members providing different levels of support. There are 8 survey questions to indicate whether network members engaged in uplifting interactions in any way. A network member with at least one interaction is counted. At each time point, the questions are asked again and reevaluated.
Measured: Change over time from baseline to 6-month
Social Network-Malfeasant
Count of network members engaging in negative caregiving social interactions (Malfeasant) for each caregiver. Each caregiver had network members providing different levels of support. There are 7 survey questions to indicate whether network members engaged in malfeasant interactions in any way. A network member with at least one interaction is counted. At each time point, the questions are asked again and reevaluated.
Measured: Change over time from baseline to 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Aug 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sato Ashida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Kansas, University of Michigan, Boston College, Drexel University
- Responsible party
- Sponsor-investigator, Sato Ashida, University of Iowa
- Investigators
- Sato Ashida, PhD, Principal investigator, University of IowaKristine Williams, RN, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932812
- Sponsor's protocol ID
- 201804835
- Other IDs
- 1R21AG056716-01A1
- Acronym
- BAB
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2019
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38859822
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Bridge (Between Clinical and Community Care): Post-diagnosis Support for Persons With Dementia and Their Families
- ClinicalTrials.gov ID
- NCT03932812
- Acronym / sponsor ID
- BAB / 201804835
- Conditions
- Caregiver Burden
- Keywords
- Alzheimer's disease, Dementia, Caregiver, Bridging community, Bridging medical settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sato AshidaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Kansas, University of Michigan, Boston College, Drexel University
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 16 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Options Counselor Health Educator Intervention Group | Experimental | Behavioral: Options Counselor Health Educator (OC-HE) InterventionThese individuals will receive the Options Counselor Health Educator Intervention |
| Control | No intervention | –These individuals will receive the typical standard of care treatment from clinics |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age
- Speaks English
- Lives in Iowa
- Caregiver of someone diagnosed with dementia within the past 6 months
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Options Counselor Health Educator (OC-HE) InterventionThe 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 | Behavioural | Options Counselor Health Educator Intervention Group |
Primary outcome
Modified Zarit Burden Interview
Time frame: Change over time from baseline to 6-month
Caregiver burden 12 item self report questionnaire; Minimum score 0, maximum score 36 with low scores showing less burden
5 secondary outcomes
Knowledge of Formal Services
Time frame: Change over time from baseline to 6-month
Center for Epidemiologic Studies Depression
Time frame: Change over time from baseline to 6-month
Emergency Care Use
Time frame: Change over time from baseline to 6-month
Social Network-Uplift
Time frame: Change over time from baseline to 6-month
Social Network-Malfeasant
Time frame: Change over time from baseline to 6-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38859822Ashida 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sato Ashida, PhD principal investigator
University of Iowa
Kristine Williams, RN, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Options Counselor Health Educator (OC-HE) Intervention in people with Caregiver Burden, run by Sato Ashida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Zarit Burden Interview (time frame: Change over time from baseline to 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.