Improving Health in Diabetes Project

NCT02672176 | Completed Results

• 1 other identifier: 820612
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; Motivational Interviewing; Mobile Health Technology; Patient-generated Health Data (PGHD)

Outcome Measures

Primary Outcomes (3)

• Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 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

  Baseline

• Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)

  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

  3 months

• Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 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.

  9-months

Secondary Outcomes (6)

• Depression Severity Measured by PHQ-9

  Baseline

• Depression Severity Measured by PHQ-9

  3 months

• Depression Severity Measured by PHQ-9

  9-months

• Perceived Stress Measured by PSS

  Baseline

• Perceived Stress Measured by PSS

  3 months

Other Outcomes (6)

• PROMIS Emotional Distress Anxiety

  Baseline

• PROMIS Emotional Distress Anxiety

  3 months

• PROMIS Emotional Distress Anxiety

  9 months

Study Arms (2)

Usual Care-Chronic Disease Management

SHAM COMPARATOR

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.

Behavioral: Usual Care

P2E2T2 Program

ACTIVE COMPARATOR

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).

Behavioral: P2E2T2 Program

Interventions

Usual Care BEHAVIORAL

This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. 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.

Usual Care-Chronic Disease Management

P2E2T2 Program BEHAVIORAL

The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:

P2E2T2 Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Does not have Diabetes Mellitus
• Primary language is not English
• Pregnant women
• Those that not have access to a telephone or computing device
• Has a HgbA1C value under 6.5%

Sponsors & Collaborators

• University of California, Davis: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

School of Nursing, University of California, Davis and UC Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (3)

• Young HM, Miyamoto S, Dharmar M, Tang-Feldman Y. Nurse Coaching and Mobile Health Compared With Usual Care to Improve Diabetes Self-Efficacy for Persons With Type 2 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 2;8(3):e16665. doi: 10.2196/16665.

  PMID: 32130184 DERIVED

• Miyamoto S, Dharmar M, Fazio S, Tang-Feldman Y, Young HM. mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Feb 15;7(2):e45. doi: 10.2196/resprot.9168.

  PMID: 29449200 DERIVED

• Broadbent E, Garrett J, Jepsen N, Li Ogilvie V, Ahn HS, Robinson H, Peri K, Kerse N, Rouse P, Pillai A, MacDonald B. Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Feb 13;20(2):e45. doi: 10.2196/jmir.8640.

  PMID: 29439942 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Participants might have been more ready to change and to use technology than the general population. With the short intervention, we did not expect change in body mass index or A1C; instead focusing on outcomes important to patients with diabetes.

Results Point of Contact

• Title: Heather M. Young, Principal Investigator
• Organization: University of California, Davis

hmyoung@ucdavis.edu

916-734-4745

Study Officials

• Heather Young

  UC Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: February 3, 2016
• Study Start: February 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 23, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)