Improving Health in Diabetes Project

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: P2E2T2 Program; Behavioral: Usual Care

• Registration Number: NCT02672176
• Lead Sponsor: University of California, Davis

Brief Summary

The overall goal of this proposal is to enhance the supports and resources available to patients with diabetes to assist them to achieve their health goals. The investigators will evaluate an innovative program that uses nurse health coaching, motivational interviewing techniques, wireless sensors and mobile health (mHealth) technology. In this program, patients will receive timely, tailored nurse coaching feedback to facilitate behavior change using mHealth technology, thus bridging bidirectional exchange of meaningful information among patient, nurse coach and provider. The investigators will conduct a randomized controlled trial among patients receiving chronic disease management at the University of California Davis(UC Davis) Primary Care Network. The patients who are eligible for inclusion in the study will be randomized to one of two arms of the trial: 1) Usual care (Care Coordination) administered by UC Davis Health Management and Education; or 2) the Patient and Provider Engagement and Empowerment through Technology (P2E2T2) Program to Improve Health in Diabetes. The hypothesis is that patients in the P2E2T2 arm of the study will be more engaged in identifying and achieving health goals related to their diabetes and will achieve better health outcomes compared to patients receiving usual care.

Detailed Description

Diabetes mellitus (DM) is a growing public health problem highly amenable to prevention and health promotion interventions. Over 26 million people are diagnosed with diabetes, and an estimated 79 million people have pre-diabetes (1). Physical inactivity, poor eating habits, obesity and smoking are common risk factors for multiple chronic diseases, including DM, and are associated with premature deaths in the United States (2). Traditional interventions for diabetes emphasize education and typically do not address patient-generated health data (3). Motivational interviewing (MI) is a counseling tool to improve self-efficacy and support behavioral changes that has been used successfully in treatment of addictions and chronic conditions including diabetes (4-6). MI focuses on enhancing goal-setting skills by encouraging focus on manageable steps to improve overall health, establishing reasonable goals, and managing barriers and obstacles to goal attainment. Mobile health (mHealth) technology can be used to allow bi-directional, timely communication of data and tailored feedback between the patient and health care team; thus mHealth has the potential to change an individual' health behavior and prevent factors that lead to disease (7). This proposal tests the effectiveness of nurse coaches and the mHealth platform as resources to patients. Specifically, the investigators will test a mobile technology-enabled nurse coaching intervention as a means to engage and empower patients to set their own personal goals to address lifestyle and behavioral changes to better manage their diabetes and comorbidities. The addition of a wireless sensing wearable device to monitor participant activities (physical activity, energy expenditure and sleep quality) will allow the investigators to perform meaningful analysis of patient-generated health data and provide tailored feedback to motivate the patient to reach personal goals. The investigators will achieve this project through the following Specific Aims:

Specific Aim 1: To evaluate the effectiveness of the P2E2T2 program on diabetes management as measured by the following outcomes: 1) quality of life (QOL); 2) self-efficacy; 3) readiness to change; and 4) clinically relevant outcomes.

This study is a randomized, controlled trial with two groups: 1) Usual care (Care Coordination); and 2) the Patient and Provider Engagement and Empowerment Through Technology (P2E2T2) program - nurse coaching paired with mobile sensor technology to provide targeted feedback of patient-generated, real-world community physical activity and sleep quality data to the nurse coach, participants, and primary care providers to improve self-management of diabetes. Participants will be recruited from the UC Davis Primary Care Clinics network. After enrollment in the study, those randomized to receive the intervention will interact with their nurse coach through mobile technologies by telephone, or by text/e-mail through the secure mHealth dashboard platform established for communication and transfer of data. The investigators expect to enroll at least 150 patients in each of the intervention and control arms. This sample size will be sufficient to detect differences between the two groups. Even under the conservative assumption that design effects and dropout rates may result in a reduced sample size of 100 per treatment group, the study will still have at least 80% power to detect the specified clinically important effect size. Based on a previous study of nurse coaching using MI to improve disease self-management (8), the investigators found improvement in self-efficacy scores significantly higher in the intervention group compared to the control group. Data will be collected from participants at three time points: 1) baseline data at time of recruitment; 2) 3 months (coinciding with the completion of the intervention); and 3) 9 months (selected to assess sustained effects of the intervention (6 months after intervention ended)). At baseline, in addition to outcomes, all participants will complete a demographic survey which will include age, gender, race/ethnicity, education level, income level and insurance type and health history using the Charlson Comorbidity Index which includes common chronic conditions. All data for the study will be collected by the research coordinator and entered into the REDCap (Research Electronic Data Capture) system housed in the servers managed by UC Davis Clinical and Translational Science Center (CTSC) (9).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-20
• Study First Submitted QC: 2016-01-29
• Study Start: 2016-02
• Study First Posted: 2016-02-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2018-06-28
• Results First Submitted QC: 2019-08-12
• Results First Posted: 2019-09-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

1. At least 18 years of age
2. Diagnosis of Diabetes Mellitus (type 2)
3. Receiving care at one of the UC Davis Primary Care participating clinics (hospital-based Primary Care Clinic, the Folsom Primary Care Clinic)
4. Able to read, write, and speak English
5. Has access to a telephone and computing device
6. Has had experience with use of a mobile smartphone & applications
7. HgbA1C over 6.5%

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Exclusion Criteria

1. Does not have Diabetes Mellitus
2. Primary language is not English
3. Pregnant women
4. Those that not have access to a telephone or computing device
5. Has a HgbA1C value under 6.5%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P2E2T2 Program	P2E2T2 Program	The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (2, 3). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org).
Usual Care-Chronic Disease Management	Usual Care	Usual Care through Chronic Disease Management: The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.

Primary Outcome Measures

Name	Time	Method
Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline	Baseline	Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas
Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)	3 months	Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas
Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months	9-months	Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas.

Secondary Outcome Measures

Name	Time	Method
Depression Severity Measured by PHQ-9	9-months	Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.
Perceived Stress Measured by PSS	9 months	Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.

Trial Locations

Locations (1)

School of Nursing, University of California, Davis and UC Davis Health System; 🇺🇸 Sacramento, California, United States