- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03932812
Building a Bridge (BAB) Between Clinical and Community Care (BAB)
Building a Bridge (Between Clinical and Community Care): Post-diagnosis Support for Persons With Dementia and Their Families
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Options Counselor Health Educator Intervention Group
These individuals will receive the Options Counselor Health Educator 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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change over time from baseline to 6-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of Formal Services
Time Frame: Change over time from baseline to 6-month
|
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.
|
Change over time from baseline to 6-month
|
Center for Epidemiologic Studies Depression
Time Frame: Change over time from baseline to 6-month
|
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.
|
Change over time from baseline to 6-month
|
Emergency Care Use
Time Frame: Change over time from baseline to 6-month
|
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
|
Change over time from baseline to 6-month
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Social Network-Uplift
Time Frame: Change over time from baseline to 6-month
|
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.
|
Change over time from baseline to 6-month
|
Social Network-Malfeasant
Time Frame: Change over time from baseline to 6-month
|
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.
|
Change over time from baseline to 6-month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiving Self-Efficacy
Time Frame: Change over time from baseline to 6-month
|
5-item self-reported measure assessing caregivers' confidence to use community-based services.
The scale ranges on level of certainty from "not at all certain" to "very certain."
The responses are scored on a scale of 0-10.
These scores are summed up for a final score of 0-50, with a 50 being the highest knowledge of formal services.
Questions include how certain the caregiver can get answers to all questions about services in the community, find organizations or agencies that provide services in need, arrange for services themselves, get answers to all questions about the individual's care, and get answers to changes in services due to the COVID-19 pandemic.
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Change over time from baseline to 6-month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sato Ashida, PhD, University of Iowa
- Principal Investigator: Kristine Williams, RN, PhD, University of Kansas School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201804835
- 1R21AG056716-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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