| Registry | NCT07016178, acronym INCLUDE |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 3454 (Actual) |
| Sponsor | Indiana University (Other); collaborators: University of Southern California |
| Conditions | Mild Cognitive Impairment (MCI), Alzheimer Disease, Alzheimer's Disease (Incl Subtypes), Dementia, Cognitive Decline |
| Interventions | Acceptability and Feasibility of Twistle messaging for PDM+ patients (Behavioral) |
| Dates | start 2025-10-13, primary completion 2026-01-15, completion 2026-01-15, first posted 2025-06-11, last updated 2026-08-04 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Mild Cognitive Impairment (MCI) All trials for Alzheimer Disease All trials of Acceptability and Feasibility of Twistle messaging for PDM+ patients
Recent studies have highlighted the potential use of electronic health record (EHR) data for scalable and less biased identification of people who may have or be at risk of developing MCI or ADRD at the population level.8,9 Using data from the EHR in advance of PC visits can systematically identify patients with undetected MCI and ADRD. At Indiana University (IU), researchers developed a Passive Digital Marker (PDM) to enable early detection of ADRD with an 80% accuracy for one-year and three-year prediction horizons.8,9 Despite the accuracy of the PDM, the feasibility, acceptability, and overall effectiveness of its use for early detection of ADRD in PC remains unclear.
Building on this innovative tool and the ongoing engagement in IUH PC for early detection of ADRD, we propose a project to test the acceptability and feasibility of implementing the PDM in IUH PC to identify people with and at risk of MCI and ADRD and measure if we can increase patient engagement in research and evidence-based follow-up care with the IUH Brain Health Navigator (BHN). The BHN, is primary care based registered nurse with special training to conduct additional assessments of patients following a positive ADRD screen to identify possible underlying causes of cognitive impairment and assist the PCP to facilitate the patient's next steps for diagnostic assessment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PDM+ | Experimental | Behavioral: Acceptability and Feasibility of Twistle messaging for PDM+ patients | Patients at participating clinics identified through the Passive Digital Marker (PDM) as at risk will be contacted for clinical follow up via Twistle, a secure text message platform prior to their next schedule primary care visit. Patients identified as at risk, PDM+, who confirm a cognitive concern via Twistle will be referred to the IU Health Brain Health Navigator (BHN), a clinical nurse embedded in primary care. . The BHN will deliver the IUH Brain Health Protocol to assess for reversible causes, initiate shared decision-making processes for care and treatment, assess for treatment eligibility, and complete a warm hand-off when appropriate. Additionally, the BHN will facilitate patient enrollment in the Indiana CTSI ALL IN research registry and/or the IU Biobank. |
Sex: All, ages: 65 Years to any
Inclusion Criteria: * 65 years and older; established patients of 12 selected clinics at IU Health PC who are identified by the PDM as high risk for developing or having undetected MCI or ADRD. Exclusion Criteria: * Patients younger than 65 years; Patients with less than 2 years of available EHR data; individuals whose primary language is not English; and current diagnosis of ADRD or MCI; and current diagnosis of bipolar disorder or schizophrenia.
| Facility | City | Country | Status |
|---|---|---|---|
| IU Health Primary Care | Indianapolis, Indiana | United States |