Ignite Creation Date:
2025-12-18 @ 8:29 AM
Ignite Modification Date:
2025-12-23 @ 10:49 PM
Study NCT ID:
NCT03932812
Status:
None
Last Update Posted:
2025-11-19 00:00:00
First Post:
2019-04-16 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Building a Bridge (BAB) Between Clinical and Community Care
Sponsor:
None
Organization:
Study Overview
Official Title:
Building a Bridge (Between Clinical and Community Care): Post-diagnosis Support for Persons With Dementia and Their Families
Status:
None
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAB
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: