A Pharmacist and Health Coach–Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study

Background Aggressive management of blood glucose, blood pressure, and cholesterol through medication and lifestyle adherence is necessary to minimize the adverse health outcomes of type 2 diabetes. However, numerous psychosocial and environmental barriers to adherence prevent low-income, urban, and ethnic minority populations from achieving their management goals, resulting in diabetes complications. Health coaches working with clinical pharmacists represent a promising strategy for addressing common diabetes management barriers. Mobile health (mHealth) tools may further enhance their ability to support vulnerable minority populations in diabetes management. Objective The aim of this study is to evaluate the impact of an mHealth clinical pharmacist and health coach–delivered intervention on hemoglobin A1c (HbA1c, primary outcome), blood pressure, and low-density lipoprotein (secondary outcomes) in African-Americans and Latinos with poorly controlled type 2 diabetes. Methods A 2-year, randomized controlled crossover study will evaluate the effectiveness of an mHealth diabetes intervention delivered by a health coach and clinical pharmacist team compared with usual care. All patients will receive 1 year of team intervention, including lifestyle and medication support delivered in the home with videoconferencing and text messages. All patients will also receive 1 year of usual care without team intervention and no home visits. The order of the conditions received will be randomized. Our recruitment goal is 220 urban African-American or Latino adults with uncontrolled type 2 diabetes (HbA1c ≥8%) receiving care from a largely minority-serving, urban academic medical center. The intervention includes the following: health coaches supporting patients through home visits, phone calls, and text messaging and clinical pharmacists supporting patients through videoconferences facilitated by health coaches. Data collection includes physiologic (HbA1c, blood pressure, weight, and lipid profile) and survey measures (medication adherence, diabetes-related behaviors, and quality of life). Data collection during the second year of study will determine the maintenance of any physiological improvement among participants receiving the intervention during the first year. Results Participant enrollment began in March 2017. We have recruited 221 patients. Intervention delivery and data collection will continue until November 2021. The results are expected to be published by May 2022. Conclusions This is among the first trials to incorporate health coaches, clinical pharmacists, and mHealth technologies to increase access to diabetes support among urban African-Americans and Latinos to achieve therapeutic goals. International Registered Report Identifier (IRRID) DERR1-10.2196/17170


R0DK108141-01A1
3 HDEP GERBER, B phone text messaging, videoconferencing, health coaches, and clinical pharmacists in diabetes management support services.

CRITIQUE 1
Significance: 1 Investigator(s): 1 Innovation: 4 Approach: 4 Environment: 1 Overall Impact: These are very skilled researchers addressing a highly significant problems in both African American and Latino populations. The investigators have been responsive to a previous review. The study design, power and statistical analyses are sophisticated and appropriate, and the process and program evaluation are salient features. Concerns about secondary outcome measures and potential contamination reduce enthusiasm for the proposal, as does the modest amount of innovation. Nevertheless, the combined pharmacist/health coach/mHealth intervention holds promise of success.

Significance: Strengths
 Diabetes is a problem among African-Americans and Latinos, many of whom are at high risk for complications given a lack of adherence to treatment recommendations.  Clinical pharmacists are underutilized in terms of their potential to promote behavior change for risk reduction in community populations.  More proven in this regard are health coaches who can be very effective but need an expert's guidance, as is offered through this mHealth intervention.

Weaknesses
 None noted

Investigator(s): Strengths
 This study is being led by Drs. Ben Gerber and Lisa Sharp. Dr. Gerber has an MD as well as an MPH in public health informatics. Dr. Sharp has a PhD in clinical psychology with additional postdoctoral training in health psychology. Dr. Sharp also has a bachelor's degree in nursing and worked for a decade in this area therefore, adding to her qualifications. The two have collaborated on a closely related R01 funded by NIDDK that is concluding this spring. These two and their collaborators comprise a highly qualified team well positioned to carry out this study effectively.  The PIs and team have relevant research experience working with all technology components of the intervention, as well as conducting research that involves the inclusion of pharmacists and health coaches. Weaknesses  None noted.

Innovation: Strengths
 The partnership between clinical pharmacists and health coaches with the addition of mHealth is innovative and unique. Weaknesses  The assertion that health coaches using video conferencing is novel can be challenged. For example, Ramirez and her colleagues were using closed circuit TV and promotoras 30 years 1 R01 DK108141-01A1 4 HDEP GERBER, B ago in the Eagle Pass and Rio Grande areas of Texas 3. Of course, the technology was more basic but the theme was the same.
 REAIM and long term follow up are empirical strengths but are not innovations. Generally, this section is overstated.

Approach: Strengths
 The randomized design and especially block randomization to ensure race, gender and site balance is commendable.
 The recruitment and retention plans are detailed, clearly based on past success.  The sample size estimation and statistical analyses sections are clear and appropriate for the study aims and will include intention-to-treat models.
 Process and program evaluation ideas (e.g. the cost-effectiveness analysis) are also very good.  Finally, the outcome evaluation emphasizes medication adherence, hemoglobin A-1 C, blood pressure and LDL-cholesterol, very appropriate for this study's aims. Weaknesses  The conceptual framework comprises a wide range of theories (e.g. SCT and HBM) which individually would be all inclusive and very non-specific. Motivational Interviewing will be used, with no attempt to weave it into the other models. The interventions seem to be retrofitted onto this overly general framework, yielding a mixture that is really just a kitchen sink approach. Hypotheses are derived from the literature and the authors' own research but not from these theories.
 Detail is needed on the exclusion criterion of 'comprehension' and 'impaired decision making'.  Will the pharmacist be sure not to 'contaminate' control subjects with intervention-based information?
 24 hour diet recalls and the IPAQ can be challenged in terms of their reliability and validity, especially with participants who may be at lower levels of literacy and education. Internal consistencies as low as .47 would not generally be adjudged "acceptable" (p. 90).

Environment: Strengths
 The campus and health system environments are excellent.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections

Inclusion of Women, Minorities and Children:
 Sex/Gender: Distribution justified scientifically  Race/Ethnicity: Distribution justified scientifically  Inclusion/Exclusion of Children under 21: Excluding ages < 21 justified scientifically  No concerns identified.  The resubmission is largely responsive though concerns remain about the approach and innovation.

Budget and Period of Support:
Recommend as Requested  No concerns were identified.

CRITIQUE 2
Significance: 1 Investigator(s): 2 Innovation: 3 Approach: 4 Environment: 1 Overall Impact: This resubmission addresses the effectiveness of a mHealth diabetes care adherence support program, delivered by pharmacists and health coaches in African American and Latinos with uncontrolled diabetes. The project focuses on a compelling problem in this high risk and underserved population. The concerns raised in the previous review have been addressed. The project is well described, the investigative team is strong and previous and ongoing studies on the topic further support its merit. Inclusion of the health economist is a particular strength. Concerns include lack of information about how contamination will be prevented, and lack of detail about how motivational interviewing will be integrated. Information regarding the training and expertise (biosketches) of two of consultants was not apparent.

Significance: Strengths
 Diabetes is a significant burden among African-American and Latino populations; interventions to improve self-management adherence are desperately needed.  Numerous barriers to successful self-management can be overcome potentially with mobile health technologies that promote easier access, communication, and patient education, including text messaging and video conferencing (mHealth).  Integrating services-clinical pharmacists and health coaches to support self-management.

Weaknesses
 None noted

Investigator(s):
Strengths  A strong and well qualified team has been assembled to carry out the project.  A health economist has been added to the team as recommended in the prior review. Weaknesses 1 R01 DK108141-01A1 6 HDEP GERBER, B  Dr. Fisher (consultant) will provide expertise in sustainable peer support models of diabetes management and Dr. Fairbanks (consultant) will provide training in motivational interviewing related to adherence. However, biosketches were not available nor are they listed in key personnel.

Innovation: Strengths
 Pharmacists and health coaches, videoconferencing and text messaging technology.  Cost effectiveness analyses.  Scientific expertise, the issue of sustainability and the RE-AIM framework.

Weaknesses
 The field of mobile health technology and its use in under-served and high risk populations has a history of at least 25 years or more.

Approach: Strengths
 Addresses issues raised in prior review regarding potential overlap with a current study that ends in April, 2016 (i.e. pharmacists and health coaches with no mobile health technology).
 RCT design; further detail about behavioral outcome measures.  Availability of a low cost two-way text messaging application developed from experience in other studies (i.e. the Moving Forward weight loss intervention).
 Strong pilot work with the target populations.  Conceptual framework guiding the study that integrates health belief, social cognitive theory, social support and problem solving. Weaknesses  Although motivational interviewing will be used, it is not clear how it is integrated with the other theories.
 Unclear how contamination will be avoided.

Environment: Strengths
 Excellent resources and facilities to support the study.

Weaknesses
 None noted

Resubmission:
 The concerns raised in the previous review have been addressed.

Budget and Period of Support:
Recommend as Requested  No concerns were identified.

CRITIQUE 3
Significance: 2 Investigator(s): 1 Innovation: 2 Approach: 2 Environment: 1 Overall Impact: This applications addresses diabetes in black and Latino adults; it uses mHealth with a clinical pharmacists and health coach. If proven effective it will provide a model for integrating pharmacists in chronic disease management and extend the use of telehealth in health disparities populations.

Significance: Strengths
 It is a significant study given the morbidity and mortality associated with diabetes in racial and ethnic minority populations.

Weaknesses
 None noted

Investigator(s):
Strengths  Dr. Gerber is an internist with expertise in conducting studies with diabetes population and in using mHealth and telehealth technology to impact health behaviors. He has developed mobile health applications that will be used on this study. He is supported by a team of health economists, pharmacists, behavioral health and social psychology researchers. Weaknesses  None noted.

Innovation: Strengths
 Their prior study demonstrated that patients were reluctant to stay after a visit and discuss their care with a pharmacist because of time and they did not want to come back for a visit.
 However, videoconferencing with the pharmacist working remotely and a health coach in the home is an alternative and innovative solution which they are testing in this application. Weaknesses