Clinical Trial 56431

Louisville, KY 40202


Summary:

Methods: Upon completion of HOPE App 2.0 product development milestones (Aims 1 and 2), we will implement a clinical validation study with 130 older adults with T2DM. We will use a waitlist control study design to compare the HOPE App intervention to usual care, as it would be unethical to withhold evidence-based care to patients with T2DM.

Our primary outcome will be mean change in glycemic control (A1c) from baseline to 6 month follow up. Secondary outcomes include mean change in diabetes distress scores, patient engagement defined as proportion of participants enrolled who demonstrate sustained engagement with HOPE App programming at six months following enrollment and mean changes in participant adherence to self-management behaviors using the Summary of Diabetes Care Self-Assessment questionnaire (SDCSA) and Morisky Medication Adherence scale (Please see clinical trial protocol in human subjects section for complete details)43, 44.

 

Target Population. 130 eligible participants who have a baseline A1c of >7.5%, 65+ yo, and fluent in English. access to internet and laptop computer or chromebook.  A letter from primary care doctor indicating safety to participate in a lifestyle management program and most recent result of HgbA1c with test date will be required.

Study Design: The proposed study is a randomized wait-list controlled clinical trial. The analytic objectives are to (a) characterize implementation in real world conditions, (b) assess change from baseline to 6 months in clinical outcomes. We chose this design because it is a methodology that guides the assessment of whether an intervention works when introduced into real-life conditions. We will randomize participants into two groups: an immediate treatment group (ITG) and a wait-list-control (WLC) group. The ITG group immediately begins using the HOPE APP 2.0 to complete a DSME curriculum for a total duration of 6 months (month 10-16). The WLC group receives usual care for the first six months, at which point they will be offered the HOPE App intervention for a total of 6 months.   After the 6-month intervention period, we will offer the ITG group ongoing access to the Hope App maintenance programming and platform and monitor participation for an additional 6-month period (through month 22), to assess ITC long-term engagement at 12 months from baseline.

Digital Divide Plan. SYH will provide a loaner Chromebook or Android Tablet for eligible participants who do not have a suitable mobile device. Participants will return the device upon completion of study participation, or may keep the device in lieu of the study stipend. We successfully used this plan in our WIC studies.  Participant will need access to WIFI internet.

Randomization and Informed Consent. Participants will be randomized at the patient level after baseline data collection. SYH research staff will run the informed consent process including ensuring eligible participants are competent to provide informed consent through structured teach-back communication. All eligible participants will receive written informed consent. We will use Docu-sign’s HIPAA compliant software to complete informed consent remotely. All staff will be trained in human subjects research ethics and informed consent best practices.

Intervention. The HOPE App is an immersive telehealth intervention aimed at improving self-management skills and reducing the psychosocial and emotional burden of diabetes among adults with uncontrolled T2DM. SYH’s accredited, evidence-based DSME/S curriculum will be offered on demand and in weekly live action programming in our immersive virtual world classroom.

We will onboard patients through our newly designed automated registration portal. Patients will create a personal profile and customized avatar for navigation in the platform after which they may participate in scheduled and on-demand programming as desired to complete the evidence-based core curriculum and maintenance modules over a 6-month period.  Participants will complete patient reported outcomes assessments every 2 weeks to inform coaching program and risk surveillance. 

The central components of SYH’s DSME playbook is group learning together with formal and informal self-management practices aimed at developing the cognitive, behavioral, and physical capacities to manage diabetes and reduce psychosocial burdens including diabetes-related distress. In addition to completing the prescribed educational content, each enrolled participant will meet 1:1 with a trained health coach using the HOPE App Telehealth videoconferencing feature a total of 12 times in the six-month study period.

Waitlist Control. Patients in the wait-list control condition will receive medical treatment as usual. WLC participants will be restricted from participating in formal DSME programming offered through their providers during the study period.

Primary Outcome Measures. We will assess all outcomes at baseline, 3 and 6 months (Table 5, protocol). The primary outcome measurement will be mean change in glycemic control as measured by A1c. A mean change of 0.5% will be the a priori determined clinically meaningful minimum improvement from baseline to 6 months.   Participants will be asked to wear a continuous glucose monitor for a 10 day period at baseline, three months and six months data collection periods. 

Secondary outcomes: We will assess mean changes in patient reported outcomes (diabetes distress), patient engagement and adherence to self-management behaviors at baseline, three months and six months (Summary of Diabetes Self Care Assessment and Moritzky Medication Adherence surveys). Patient engagement with the HOPE App platform will also be assessed at 12 months for the ITG arm to determine long term retention rates.

 


Criteria:
  • have a baseline A1c of >7.5%
  • age 65 or older
  • fluent in English
  • have access to internet and a computer or Chromebook
  • a letter from primary care doctor indicating safety to participate in a lifestyle management program and most recent result of HgbA1c with test date will be required
  • no history of cognitive impairment or serious mental illness
  • no current pregnancy or dialysis treatment


Qualified Participants May Receive:

Diabetes education and health coaching through the HOPE app computer program. Because of the study design, some participants will use See Yourself Health’s HOPE App program right away. Other participants will wait 6 months before they can use the HOPE App. During this time, participants will receive care as usual. All participants will also complete surveys at 4 time points.If you decide to take part, your time in this study will last at least 6 months with an option to continue participating up to 12 months. 

Qualified participants will receive up to $375 in gift card compensation. 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.