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| ID | Type | Description | Link |
|---|---|---|---|
| R21MD016949-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of the study is to develop and evaluate a multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
Prior to the clinical trial, qualitative methods were used to inform the intervention protocol. For the clinical trial, a pilot study will be conducted to evaluate the effect of the intervention on patient portal use, patient engagement with care, and clinical outcomes in adults with type 2 diabetes. The focus of this registration is the clinical trial.
Using a within subjects, pre-post design the investigator will pilot MAP in an anticipated 30 adults with T2D who are not using the portal. Data will be collected at baseline, 3, and 6 months. The investigators will evaluate the feasibility of MAP using an established framework (acceptability, demand, implementation, adaptation, and integration.
The intervention will consist of the following:
MAP will be delivered by community health workers (CHW) and nurses already embedded in CHCs (healthcare system). The 3-month intervention is thoughtfully sequenced to first have CHWs address patient portal access (tablet, home internet), and then move on to patient mastery of the tablet and portal functionality. Next, CHWs will assess social determinants of health using an established measure and connect the participant to relevant community resources (e.g., SNAP benefits). It is anticipated that participants will have 4-6 individual sessions with the CHW, approximately 30 minutes each, followed by ongoing technology support as needed.
Next, the clinic nurse will proactively contact the participant via the portal to provide diabetes self-management support. The nurse will begin by assessing participant behaviors and will then work with the participant to co-create a plan to help with diabetes self-management. The plan will include referral to relevant ancillary clinic services as needed (e.g., DSM education [DSME], nutritionist, obtaining a glucose meter). Participants will be instructed and encouraged to upload blood glucose data and communicate with the nurse and their health care provider via the portal, both of which have been shown to improve glycemic control. The nurse will work with each patient to individualize DSMS behavioral targets, considering the following priorities: use of the portal, attendance at appointments, uploading of blood glucose data to the portal, medication refills and adherence, and lifestyle and emotional factors. It is anticipated that nurses will communicate with patients via the portal at least twice weekly during the first month followed by ongoing DSMS as needed. In-person or telehealth sessions will be scheduled as needed. However, the exact sequence, timing, and length of sessions will be participant driven. For example, a participant who learns the portal quickly may proceed at a faster rate, or a participant who already uploads glucose data may skip that step.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of patient portal for diabetes management | Experimental | A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of patient portal for diabetes management | Behavioral | A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs). |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Portal | Frequency. Mean portal login days/per month will be calculated using the EMR system | Monthly for 6 months |
| Change in A1C Value | The A1C value will be assessed via fingerprick point of care A1c kits. | Baseline, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Self-Care in Diabetes Survey- Diet | Diet - following diabetes diet over past 7 days (score range 0-7, with higher scores indicating better self-care) | Baseline, 3 months, and 6 months |
| Diabetes Self-Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Whittemore, PhD, APRN | Yale University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fair Haven Community Health Center | New Haven | Connecticut | 06510 | United States | ||
| Norwalk Community Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41567495 | Derived | Wagner J, Akyirem S, Lipson J, Chen HN, Whittemore R. Evaluation of the implementation of a patient portal pilot intervention among people with type 2 diabetes at community health centers. Front Clin Diabetes Healthc. 2026 Jan 6;6:1689830. doi: 10.3389/fcdhc.2025.1689830. eCollection 2025. | |
| 40131327 | Derived | Whittemore R, Jeon S, Akyirem S, Chen HNC, Lipson J, Minchala M, Wagner J. Multilevel Intervention to Increase Patient Portal Use in Adults With Type 2 Diabetes Who Access Health Care at Community Health Centers: Single Arm, Pre-Post Pilot Study. JMIR Form Res. 2025 Mar 25;9:e67293. doi: 10.2196/67293. |
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Participants were recruited from two community health centers. Flyers were posted in the clinics. Clinic personnel identified potentially eligible participants and if interested, would refer to research team. A trained research assistant provided information about the study and obtained informed consent in the preferred language of participant (Spanish or English).
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Patient Portal for Diabetes Management | A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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There were 4 participants lost to follow-up so their data was not included in our final report. They were not exposed to any aspect of the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Patient Portal for Diabetes Management | A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
|
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usage of Portal | Frequency. Mean portal login days/per month will be calculated using the EMR system | Posted | Mean | Standard Deviation | days per month | Monthly for 6 months |
|
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From enrollment to approximately 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use of Patient Portal for Diabetes Management | A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Whittemore | Yale | 203-432-7000 | robin.whittemore@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2023 | May 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2021 | May 24, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Self-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy)
| Baseline, 3 months, 6 months |
| Health Care Climate Questionnaire | Perception of support by health care providers with higher scores indicating more perceived support, scores range from 1-5 | Baseline, 3 months, 6 months |
| Problem Areas in Diabetes (PAID) | Score ranges from 0-100 with higher scores indicating more distress | Baseline, 3 and 6 months |
| Norwalk |
| Connecticut |
| 06854 |
| United States |
| Participants |
| No |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Primary | Change in A1C Value | The A1C value will be assessed via fingerprick point of care A1c kits. | Posted | Mean | Standard Deviation | percent | Baseline, 3 months and 6 months |
|
|
|
| Secondary | Summary of Self-Care in Diabetes Survey- Diet | Diet - following diabetes diet over past 7 days (score range 0-7, with higher scores indicating better self-care) | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 6 months |
|
|
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| Secondary | Diabetes Self-Efficacy | Self-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy) | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
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| Secondary | Health Care Climate Questionnaire | Perception of support by health care providers with higher scores indicating more perceived support, scores range from 1-5 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months |
|
|
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| Secondary | Problem Areas in Diabetes (PAID) | Score ranges from 0-100 with higher scores indicating more distress | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 and 6 months |
|
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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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| D004700 | Endocrine System Diseases |
| Title | Measurements |
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