Twistle Messaging for Alzheimer's Disease

(INCLUDE Trial)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Under 65, New patients, Non-English/Spanish speakers, ADRD/MCI diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new tool for early detection of Alzheimer's and related conditions by using secure text messaging (Twistle messaging) to engage patients flagged as high risk. Patients who have visited one of the selected clinics at IU Health for over a year and are 65 or older might be a good fit. The goal is to determine if this approach helps connect patients to care and research opportunities, such as working with a specialized nurse to explore treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance early detection and care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for early detection of ADRD?

Research has shown that Twistle, a secure text messaging platform, is generally liked by patients. Studies have found that Twistle boosts patient satisfaction by 93%, indicating that the tool is easy to use and helps keep patients involved in their care. In another program, secure text messaging was used with dementia patients to monitor falls, demonstrating that Twistle can be safely used with patients who have memory issues. The main goal is to improve communication and follow-up, not to introduce new medications or procedures. Overall, Twistle appears to be a safe and well-accepted way to help manage health conditions like Alzheimer's Disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage Alzheimer's disease risk through digital communication. Unlike standard treatments that often focus on medication, this approach uses the Twistle messaging platform to identify at-risk patients early by leveraging Passive Digital Markers (PDM). This method not only facilitates timely clinical follow-ups but also integrates personalized care by connecting patients with a Brain Health Navigator. This innovative use of technology could streamline patient care and enhance early intervention efforts, potentially leading to better outcomes.

What evidence suggests that Twistle messaging is effective for early detection of Alzheimer's disease?

Research has shown that Twistle messaging can benefit patients at risk of Alzheimer's Disease and Related Disorders (ADRD). In this trial, patients identified as at risk through the Passive Digital Marker (PDM) will receive contact via Twistle, a secure text message platform, for clinical follow-up. Studies indicate that Twistle enhances patient engagement with healthcare and boosts satisfaction. For instance, one study found that 96% of patients completed a text messaging program that tracked falls in those with Alzheimer's. This finding suggests that Twistle can effectively keep patients involved and help them adhere to their healthcare plans. By using Twistle, patients at risk can be more easily guided to the next steps in their care, potentially leading to better health outcomes. ^{1 3 5 6 7}

Who Is on the Research Team?

Nicole Fowler, PhD

Principal Investigator

Indiana University School of Medicine, and Regenstrief Institute; IU Center for Aging Research

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who are patients at selected clinics and have been identified as high risk for developing or having undetected Mild Cognitive Impairment (MCI) or Alzheimer's Disease and Related Dementias (ADRD) using a special tool called Passive Digital Marker (PDM).

Inclusion Criteria

I am 65 or older, seen at one of 12 IU Health PC clinics, and considered at high risk for early memory loss.

Exclusion Criteria

Patients who are new patients to IUH (less than 12 months)

I am younger than 65 years old.

My primary language is not English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Implementation

Implementation of the Passive Digital Marker (PDM) using IUH EHR data to identify primary care patients aged 65 or older who have undetected MCI or ADRD or who are at risk.

3 months

Ongoing monitoring via EHR

Follow-up

Participants are monitored for engagement with patient-informed messaging and completion of cognitive assessments with the Brain Health Navigator (BHN).

3 months

Follow-up via Twistle and BHN appointments

Engagement in Clinical Research

The BHN will screen patients for eligibility to participate in ADRD clinical trials and facilitate enrollment in the IU clinical research registry.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Acceptability and Feasibility of Twistle messaging for PDM+ patients

Trial Overview The study is testing the acceptability and feasibility of Twistle messaging, which aims to increase patient engagement in research and follow-up care related to brain health, particularly for early detection of cognitive impairments.

How Is the Trial Designed?

Group I: PDM+ Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6021553/

“Text It” program to track falls in patients with Alzheimer's ... Interpretation: Among 10 participants over a time frame of 1 month, there was a 96% completion rate of text messaging and 100% of calendars; however, the text- ...

2. healthcatalyst.com healthcatalyst.com/offerings/twistle-by-health-catalyst

Twistle by Health Catalyst Engage patients with personalized, step-by-step communication and guidance to improve outcomes, safety, and satisfaction · 93% improved patient satisfaction · 30% ...

3. researchgate.net researchgate.net/publication/324303743_Text_It_program_to_track_falls_in_patients_with_Alzheimer's_disease_and_dementia

“Text It” program to track falls in patients with Alzheimer's ... Results There was a 96% completion rate of text messaging and 100% of calendars; however, the text-gathered data were more accurate. Discussion ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29955657/

"Text It" program to track falls in patients with Alzheimer's ... Results: There was a 96% completion rate of text messaging and 100% of calendars; however, the text-gathered data were more accurate. ...

5. healthcatalyst.com healthcatalyst.com/learn/videos/twistle-patient-engagement-life-sciences

Twistle Patient Engagement for Life Sciences Twistle is the Health Catalyst digital patient engagement software that guides patients throughout all phases of their care journey.

6. providence.org providence.org/-/media/project/psjh/providence/or/files/brain-and-spine-institute/twistle_patient-collateral_faq.pdf?rev=f58b6bfde02247d9b505ce6819aa0558&hash=362F75FBFEF1BBE8CFC6B0B56CD661B1

What is Twistle? Your healthcare team will be sending secure text messages directly to your mobile phone, tablet or computer. Our goal is to keep your care on track by sending.

7. twistle.com twistle.com/

Twistle Apple Safari latest version. For the best experience on Twistle, please download, install, and use one of the browsers listed above.