Trial Outcomes & Findings for Telemedicine for Reach, Education, Access and Treatment-ongoing (NCT NCT04107935)

NCT ID: NCT04107935

Last Updated: 2023-12-18

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: Change every 3 months for 12 months.
• Results posted on: 2023-12-18

Participant Flow

Participants were recruited from federally qualified health centers that offered a diabetes program to high risk patients who met certain criteria.

Usual care is a historical comparison group, therefore usual care participants were not considered to be enrolled into the study.

Participant milestones

Measure	Intervention Intervention: 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 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 Care Usual Care: 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 face-to-face visit(s) 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.
Overall Study STARTED	43	30
Overall Study COMPLETED	42	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Intervention Intervention: 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 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 Care Usual Care: 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 face-to-face visit(s) 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.
Overall Study Death	1	0

Baseline Characteristics

Telemedicine for Reach, Education, Access and Treatment-ongoing

Baseline characteristics by cohort

Measure	Intervention n=43 Participants Intervention: 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 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 Care n=30 Participants Usual Care: 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 face-to-face visit(s) 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.	Total n=73 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	27 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	19 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	30 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	25 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	43 participants n=5 Participants	30 participants n=7 Participants	73 participants n=5 Participants
Hemoglobin A1c	10.8 % glycated hemoglobin n=5 Participants	10.4 % glycated hemoglobin n=7 Participants	10.6 % glycated hemoglobin n=5 Participants

PRIMARY outcome

Timeframe: Change every 3 months for 12 months.

Population: Using propensity score matching, 30 intervention participants were paired with 30 usual care participants to compare changes in hemoglobin A1c.

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.

Outcome measures

Measure	Intervention n=30 Participants Intervention: 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 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 Care n=30 Participants Usual Care: 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 face-to-face visit(s) 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.
Change From Baseline in Glycemic Control	-0.14 % change Interval -0.2017 to -0.0761	-0.14 % change Interval -0.2046 to -0.0712

SECONDARY outcome

Timeframe: Change every 3 months for 12 months total.

Population: Intervention participants

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.

Outcome measures

Measure	Intervention n=27 Participants Intervention: 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 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 Care n=15 Participants Usual Care: 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 face-to-face visit(s) 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.
Change From Baseline in Diabetes Self-care Behavior [Diet] Across 3 Month Intervals for 12 Months.	0.08 Score on a scale Interval 0.0006 to 0.1563	0.09 Score on a scale Interval -0.02313 to 0.2092

SECONDARY outcome

Timeframe: Change every three months for 12 months total

Population: Participants in the intervention group

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.

Outcome measures

Measure	Intervention n=27 Participants Intervention: 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 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 Care n=15 Participants Usual Care: 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 face-to-face visit(s) 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.
Change From Baseline in Diabetes Distress Across 3 Month Intervals for 12 Months	0.1693 Score on scale Interval -0.206 to 0.5446	-0.01655 Score on scale Interval -0.5543 to 0.5212

SECONDARY outcome

Timeframe: Change every 3 months for 12 months total

Population: Participants in the intervention group

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.

Outcome measures

Measure	Intervention n=27 Participants Intervention: 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 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 Care n=15 Participants Usual Care: 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 face-to-face visit(s) 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.
Change From Baseline in Diabetes Empowerment Across 3 Month Intervals for 12 Months	0.01418 Score on a scale Interval -0.0273 to 0.05565	0.01129 Score on a scale Interval -0.04932 to 0.07189

SECONDARY outcome

Timeframe: 12 months

Population: Participants in intervention group who completed the survey

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.

Outcome measures

Measure	Intervention n=38 Participants Intervention: 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 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 Care Usual Care: 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 face-to-face visit(s) 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.
Intervention Acceptability	4.6 Score on a scale Interval 3.95 to 5.0	—

SECONDARY outcome

Timeframe: Change every 3 months for 12 months total

Population: Participant in the intervention

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.

Outcome measures

Measure	Intervention n=27 Participants Intervention: 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 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 Care n=15 Participants Usual Care: 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 face-to-face visit(s) 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.
Change From Baseline in Medication Adherence Across 3 Month Intervals for 12 Months	0.1419 Score on a scale Interval 0.06095 to 0.2229	0.1044 Score on a scale Interval -0.01793 to 0.2267

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda Siminerio

University of Pittsburgh

Phone: 412-559-0359

Email: similx@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place