18 and older, any sex, with Type II Diabetes or Primary Health Care. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Acceptability of InterventionPrimary· At 15 months, post-intervention
A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Group
Value
95% CI
Intervention Clinics
0.60
± 0.50
Feasibility of the InterventionPrimary· At 15 months, post-intervention
A post-intervention four-item survey that evaluates the extent to which the intervention is implementable, seems possible, seems doable, and seems easy to use. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Group
Value
95% CI
Intervention Clinics
0.50
± 0.43
Appropriateness of InterventionPrimary· At 15 months, post-intervention
A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items were assessed on a Likert scale, ranging from -2 to 2 (i.e., completely disagree to completely agree, with 0 indicating neutrality). Composite scores were created by averaging scores for the four individual items. The scale range is from -2 (minimum) to +2 (maximum), where higher values represent a better outcome (more approval).
Group
Value
95% CI
Intervention Clinics
0.79
± 0.45
Change in Hemoglobin A1cSecondary· Baseline (pre-intervention) and 15-months (post-intervention).
Difference between baseline and end-of-intervention average blood sugar levels.
Group
Value
95% CI
Intervention Arm
-0.04
± 1.56
Control Arm
-0.08
± 1.35
Change in Patient Health Questionnaire-9 (PHQ-9)Secondary· Baseline (pre-intervention) and 15-months (post-intervention).
Difference between baseline and end-of-intervention PHQ-9 score.
PHQ-9: This nine-item validated screener measures depression severity. Questionnaire items are on a Likert scale and range from 0 (i.e., not at all) to +3 (i.e., nearly every day), and the total score ranges from 0 (i.e., minimal to none) to 27 (i.e., severe).
Group
Value
95% CI
Intervention Arm
-1.25
± 6.72
Control Arm
2.44
± 6.69
Sponsor's own description
In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII) and common mental and behavioral health (MH/BH) problems. In the United States, 30 million people live with DMII, and the majority receive care in primary care settings. By implementing the ADA recommendations, primary care practices will help patients better manage their MH/BH needs, meet recommended goals for DMII management, and reduce the risk of adverse outcomes. Making these recommendations a routine part of practice is a major change, and it is critical to understand how best to implement the ADA recommendations and test its effectiveness in the real world. The pilot study builds on a series of prior studies to refine and pilot test a package of implementation strategies - called INTEGRATE-D - to support practices in implementing the ADA recommendations for integrated DMII care. INTEGRATE-D combines the following evidence-based implementation strategies: (1) electronic health record (EHR)-based support - to help align EHR use with ADA recommendations and enable screening for depression, anxiety, diabetes distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback - which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources - including training on ADA-recommended care; and (4) Facilitation - to help implement the above strategies and tailor the intervention so that practice work on the subset of areas where practices are ready to change to align care with ADA recommendations. The study aims are Aim 1: Refine the INTEGRATE-D intervention by incorporating the preferences of stakeholders. In partnership with patients, primary care key stakeholders and experts, compile and refine the package of implementation strategies in the INTEGRATE-D intervention. Aim 2: Demonstrate feasibility, acceptability, and estimate cost. Conduct a mixed-method, pre-post pilot comparing two practices that receive the INTEGRATE-D intervention to two control practices that receive training materials only.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oregon Health and Science University
Last refreshed: 7 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04461405.