Diabetes MellitusTREAT-ONNCT04107935
Telemedicine for Reach, Education, Access and Treatment-ongoing
A study testing TREAT-ON in people with Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
Trial summary
Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- TREAT-ON
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 9 Dec 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Intervention group: UPMC Health Plan patient-members who are 18-75y, have diagnosis of type 2 diabetes, are considered "high risk" (HbA1c >9%), receiving care at participating Federally Qualified Health Centers, and willing and able to participate in a technology-supported intervention.
- Control group: The control group will be selected from individuals who have already participated in the UPMC Health Plan's Diabetes High Risk Initiative.
Who cannot join
- Non UPMC Health Plan patients
- Not enrolled in the UPMC Health Plan Diabetes High Risk Initiative
- Less than 18 or greater than 75 years of age
- Unwilling/unable to participate in the telemedicine diabetes education program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.
Read the detailed description
Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.
- Conditions
- Diabetes Mellitus
- Being tested
- TREAT-ON, Usual Care
- Keywords
- Self management education and support, Telemedicine, Rural
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREAT-ONBehavioural
TREAT-ON is a DE-driven self-management and support program that is delivered primarily through a real-time telemedicine videoconferencing platform. Like the usual care intervention, "high risk" patients with DM receiving care in underserved practices will be identified by a nurse practice-based manager (PCBM) and referred to a DE for self management services. Participants will complete an initial face-to-face visit with the DE to assess needs and develop a self-management treatment plan and goals. Via telemedicine videoconferencing, follow-up visits will be delivered by the DE to participants in their homes. Follow-up visits will be used to evaluate and support progress towards meeting and sustaining self-management goals and outcomes.
Usual CareBehavioural
A retrospective control group will be formed from individuals who have previously participated in a program called the "Diabetes High Risk Initiative." In this program, patients receiving care in underserved practices are identified by a nurse PBCM to be at high risk for DM complications and/or unplanned care and referred to a DE for self management services delivered through primary care. Patients typically participate in one face-to-face visit with the DE to assess needs and develop self-management goals and then one to two follow-up encounters (generally conducted by telephone) with the PBCM or DE.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: TREAT-ON |
| Usual Care | Other | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycemic Control
Average change in HbA1c every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.
Measured: Change every 3 months for 12 months.
Secondary outcomes (5)
Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.
Summary of Diabetes Self-care Activities Measure was used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors. Individual items are scored 0 (minimum) to 7 (maximum) for number of days the behavior is performed. The total possible score ranges from 0 to 7. The higher the score for dietary behavior, the better. For this study, average change in scores from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.
Measured: Change every 3 months for 12 months total.
Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months
Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012). Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress (represents worse outcome). Possible score range 1 to 6. For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.
Measured: Change every three months for 12 months total
Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months
Empowerment was measured using the 8-item Diabetes Empowerment Scale-Short Form, which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003). Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40. Higher scores indicate greater empowerment (better outcome). For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.
Measured: Change every 3 months for 12 months total
Intervention Acceptability
Telemedicine Usability Questionnaire was used to assess telehealth usefulness, ease of use and learnability, interface quality, patient-clinician interaction, reliability, satisfaction and future use and included additional items specific to this study. Individual items are scored on a scale from one to five, with one being strongly disagree to five being strongly agree. Scores are averaged for a possible score range of one to five. The higher the score infers the better the usability of the telehealth service.
Measured: 12 months
Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months
Medication adherence was assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8). The scales includes 8 items. Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered. For this study, average change in scores every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only 1 result reported per arm.
Measured: Change every 3 months for 12 months total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start4 Feb 2020
- Primary completion4 Aug 2022
- Study completion9 Dec 2022
Why it stopped: Due to COVID-19 pandemic, we were unable to meet our recruitment goal during the grant period.
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 (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Siminerio, University of Pittsburgh
- Investigators
- Linda Siminerio, RN, PhD, CDE, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107935
- Sponsor's protocol ID
- STUDY19080005
- Other IDs
- 1R34DK123370-01
- Acronym
- TREAT-ON
- Status last verified
- Dec 2023
- First submitted
- 25 Sep 2019
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of the study, study investigators will prepare a consolidated dataset with all data collected as part of this study (e.g., clinical, behavioral, psychosocial, and satisfaction). All potentially identifying information will be removed. In addition, study investigators will prepare a Manual of Operations with a detailed description of the diabetes self-management and support intervention, the technology delivery system and a full description of the TREAT-ON model for dissemination.
Publications
Siminerio L, Krall J, Johnson P, Ruppert K, Hammoudeh R, Bandi A, Ng JM. Examining a Diabetes Self-Management Education and Support Telemedicine Model With High-Risk Patients in a Rural Community. J Diabetes Sci Technol. 2023 Sep;17(5):1190-1197. doi: 10.1177/19322968231180884. Epub 2023 Jun 20.
PubMed 37338130
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for Reach, Education, Access and Treatment-ongoing
- ClinicalTrials.gov ID
- NCT04107935
- Acronym / sponsor ID
- TREAT-ON / STUDY19080005
- Conditions
- Diabetes Mellitus
- Keywords
- Self management education and support, Telemedicine, Rural
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 pandemic, we were unable to meet our recruitment goal during the grant period.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes (DM) management requires health care providers to provide patients with the appropriate amount of time, education and support that are necessary for quality care. Unfortunately, this is often impeded by limited access to resources, particularly in rural communities where DM rates are high and providers are scarce. Therefore, study investigators propose addressing these issues by implementing a model of care that includes diabetes educator (DE)-led planned visits with a real-time videoconferencing telemedicine program for ongoing patient support to improve DM outcomes.
Detailed description
Health care systems need to seek ways through quality improvement, care coordination, and workforce capacity to support quality care. It has been proposed that new models of care coupled with technology are needed. DM provides an ideal model for testing new approaches as the number of people with DM continues to rise, with an inverse shortage of health providers available to meet their needs. Most patients with Type 2 DM (T2DM) are seen in primary care (PC) where providers report barriers to comprehensive care that include limited time, educational resources, added workload and feeling ill-equipped to counsel patients on behavior change. Efforts to restructure PC are underway, like DE-led planned management visits, reported to improve healthy behaviors and outcomes in patients at high risk. DEs are well suited to support the skills, decision making, self-care behaviors, problem solving and active collaboration with the care team that serve as the foundation for diabetes self-management education and key to an effective planned visit. DEs supporting care and self-management education in PC have been shown to improve access and outcomes. For patients to sustain a lifetime of behavior to effectively self-manage, continued support to sustain the ongoing skills, knowledge, and behaviors required to manage their condition is needed. Given the need for enduring support and scarcity of providers, particularly in underserved rural areas, efforts to understand how best to re-design practice to involve DEs in PC and utilize technology to enable and scale engagement in self-management and ongoing support must be considered. The purpose of this application is to evaluate the deployment of Telemedicine for Reach, Education, Access, Treatment and Ongoing Support (TREAT-ON), a DE-driven, PC-based telemedicine model that relies on PC practice redesign to afford access to real-time ongoing support. Investigators hypothesize that the TREAT-ON model will help individuals identified as being high risk in an underserved rural community to achieve and sustain improvements in clinical, psychosocial and behavioral outcomes, and aim to demonstrate the model's viability in terms of feasibility and acceptability to inform future testing of TREAT-ON.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: TREAT-ON |
| Usual Care | Other | Behavioral: Usual Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Intervention group: UPMC Health Plan patient-members who are 18-75y, have diagnosis of type 2 diabetes, are considered "high risk" (HbA1c >9%), receiving care at participating Federally Qualified Health Centers, and willing and able to participate in a technology-supported intervention.
- Control group: The control group will be selected from individuals who have already participated in the UPMC Health Plan's Diabetes High Risk Initiative.
Key exclusion criteria (4 listed)
- Non UPMC Health Plan patients
- Not enrolled in the UPMC Health Plan Diabetes High Risk Initiative
- Less than 18 or greater than 75 years of age
- Unwilling/unable to participate in the telemedicine diabetes education program
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 |
|---|---|---|
| TREAT-ONTREAT-ON is a DE-driven self-management and support program that is delivered primarily through a real-time telemedicine videoconferencing platform. Like the usual care intervention, "high risk" patients with DM receiving care in underserved practices will be identified by a nurse practice-based manager (PCBM) and referred to a DE for self management services. Participants will complete an initial face-to-face visit with the DE to assess needs and develop a self-management treatment plan and goals. Via telemedicine videoconferencing, follow-up visits will be delivered by the DE to participants in their homes. Follow-up visits will be used to evaluate and support progress towards meeting and sustaining self-management goals and outcomes. | Behavioural | Intervention |
| Usual CareA retrospective control group will be formed from individuals who have previously participated in a program called the "Diabetes High Risk Initiative." In this program, patients receiving care in underserved practices are identified by a nurse PBCM to be at high risk for DM complications and/or unplanned care and referred to a DE for self management services delivered through primary care. Patients typically participate in one face-to-face visit with the DE to assess needs and develop self-management goals and then one to two follow-up encounters (generally conducted by telephone) with the PBCM or DE. | Behavioural | Usual Care |
Primary outcome
Change From Baseline in Glycemic Control
Time frame: Change every 3 months for 12 months.
Average change in HbA1c every 3 months from baseline through 12 months was assessed using mixed model regression with repeat measures and therefore there is only one result reported per arm.
5 secondary outcomes
Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.
Time frame: Change every 3 months for 12 months total.
Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months
Time frame: Change every three months for 12 months total
Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months
Time frame: Change every 3 months for 12 months total
Intervention Acceptability
Time frame: 12 months
Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months
Time frame: Change every 3 months for 12 months total
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37338130Siminerio L, Krall J, Johnson P, Ruppert K, Hammoudeh R, Bandi A, Ng JM. Examining a Diabetes Self-Management Education and Support Telemedicine Model With High-Risk Patients in a Rural Community. J Diabetes Sci Technol. 2023 Sep;17(5):1190-1197. doi: 10.1177/19322968231180884. Epub 2023 Jun 20.
- Individual participant dataSharing planned: Yes. After completion of the study, study investigators will prepare a consolidated dataset with all data collected as part of this study (e.g., clinical, behavioral, psychosocial, and satisfaction). All potentially identifying information will be removed. In addition, study investigators will prepare a Manual of Operations with a detailed description of the diabetes self-management and support intervention, the technology delivery system and a full description of the TREAT-ON model for dissemination.
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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.
Linda Siminerio, RN, PhD, CDE principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREAT-ON in people with Diabetes Mellitus, run by University of Pittsburgh at 1 site 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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 18 Nov 2023). 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?
Change From Baseline in Glycemic Control (time frame: Change every 3 months for 12 months.). 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 NCT04107935, which also lists 1 linked publication.
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 18 Dec 2023.