Patient EducationNCT05180721
A Multi-level Intervention to Increase Access and Use of the Patient Portal
A study testing Use of patient portal for diabetes management in people with Patient Education and Diabetes Mellitus, Type 2, run by Yale University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Education, Diabetes Mellitus, Type 2
- What is being tested?
- Use of patient portal for diabetes management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Oct 2022to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established patient of one of the partner CHCs
- Age > 18 years
- Diagnosed with T2D >6 months
- Able to read in English or Spanish
- Not using the patient portal
- A1c >7.5%
Who cannot join
- Cognitive impairment (≥3 errors on the Six Item Screener for cognitive impairment in clinical research [SIS]) (Callahan et al. 2002) as they will have difficulty in completing the study requirements
- Gestational diabetes
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fair Haven Community Health Center
New Haven, Connecticut, 06510
Norwalk Community Health Center
Norwalk, Connecticut, 06854
About this study
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).
Read the detailed description
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:
- provide free access to tablets and internet (material circumstances);
- technology training and ongoing support (psychosocial factors);
- assess social determinants of health and refer to community resources (material circumstances);
- support diabetes self-management behaviors and refer to clinic services (behavioral and biological factors).
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.
- Conditions
- Patient Education, Diabetes Mellitus, Type 2
- Being tested
- Use of patient portal for diabetes management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of patient portal for diabetes managementBehavioural
A multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Use of patient portal for diabetes management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Portal
Frequency. Mean portal login days/per month will be calculated using the EMR system
Measured: Monthly for 6 months
Change in A1C Value
The A1C value will be assessed via fingerprick point of care A1c kits.
Measured: Baseline, 3 months and 6 months
Secondary outcomes (4)
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)
Measured: Baseline, 3 months, and 6 months
Diabetes Self-Efficacy
Self-confidence in diabetes self-management tasks (score range from 1-5 with higher scores indicating better diabetes self-efficacy)
Measured: 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
Measured: Baseline, 3 months, 6 months
Problem Areas in Diabetes (PAID)
Score ranges from 0-100 with higher scores indicating more distress
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start3 Oct 2022
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient EducationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Robin Whittemore, PhD, APRN, Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180721
- Sponsor's protocol ID
- 2000031753
- Other IDs
- R21MD016949-01
- Status last verified
- Jun 2025
- First submitted
- 14 Dec 2021
- Last updated
- 10 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41567495Whittemore 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.
PubMed 40131327
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-level Intervention to Increase Access and Use of the Patient Portal
- ClinicalTrials.gov ID
- NCT05180721
- Acronym / sponsor ID
- 2000031753
- Conditions
- Patient Education, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- provide free access to tablets and internet (material circumstances);
- technology training and ongoing support (psychosocial factors);
- assess social determinants of health and refer to community resources (material circumstances);
- support diabetes self-management behaviors and refer to clinic services (behavioral and biological factors).
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of patient portal for diabetes management | Experimental | Behavioral: Use of patient portal for diabetes managementA multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Established patient of one of the partner CHCs
- Age > 18 years
- Diagnosed with T2D >6 months
- Able to read in English or Spanish
- Not using the patient portal
Key exclusion criteria (2 listed)
- Cognitive impairment (≥3 errors on the Six Item Screener for cognitive impairment in clinical research [SIS]) (Callahan et al. 2002) as they will have difficulty in completing the study requirements
- Gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of patient portal for diabetes managementA multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs). | Behavioural | Use of patient portal for diabetes management |
Primary outcome
Usage of Portal
Time frame: Monthly for 6 months
Frequency. Mean portal login days/per month will be calculated using the EMR system
Change in A1C Value
Time frame: Baseline, 3 months and 6 months
The A1C value will be assessed via fingerprick point of care A1c kits.
4 secondary outcomes
Summary of Self-Care in Diabetes Survey- Diet
Time frame: Baseline, 3 months, and 6 months
Diabetes Self-Efficacy
Time frame: Baseline, 3 months, 6 months
Health Care Climate Questionnaire
Time frame: Baseline, 3 months, 6 months
Problem Areas in Diabetes (PAID)
Time frame: Baseline, 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41567495Wagner 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.
- Derived from this study: PubMed 40131327Whittemore 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Whittemore, PhD, APRN study chair
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of patient portal for diabetes management in people with Patient Education and Diabetes Mellitus, Type 2, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage of Portal (time frame: Monthly for 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180721, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.