Diabetes Self-Management Models to Reduce Health Disparities

NCT01221090 | Completed Phase 4 Results DMC

• 2 other identifiers: 071304P20MD002295
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of two different diabetes self-management approaches (Personal Digital Assistant-based intervention \& Chronic Disease Self-Management Program) to reduce health disparities in minority, rural residents, and other underserved populations with type 2 diabetes in Central Texas. We hypothesise that: 1) Racial/ethnic minority patients with T2DM will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes, which persist even when controlling for age, gender, obesity, and insurance status; 2) Patients with T2DM who reside in more rural areas will be found to experience disparities in diabetes self-management treatment protocols and clinical outcomes as compared to more urban counterparts, controlling for age, gender, race/ethnicity, obesity, and insurance status; 3) The introduction of CSDMP and HIT protocols will improve diabetes-related self management behaviors, reduce HBA1c values, and increase quality of life in persons with T2DM as compared to controls. A combined intervention approach will result in the greatest reductions; 4) Health improvements following the introduction of CDSMP, HIT or CDSMP/HIT protocols in persons with T2DM compared to controls will be more marked in racial/ethnic minority patients and those patients residing in rural areas; 5) The introduction of self-management interventions will be cost-effective in reducing HbA1c values over time, and associated health care utilization including overall reduction in ER and acute care hospital admissions; 6) Although there is little prior research in this area to guide specific hypotheses, we hypothesize that, overall, there will be no significant cost-effective differential in CDSMP as compared to HIT approaches, although the cost-effective ratio may be stronger in particular subpopulations. The combined approach will have higher costs, but is also anticipated to have a higher cost-benefit ratio for minority populations; 7) The majority of clinicians will be willing to let their patients enroll in the study and will reinforce intervention protocols; and 8) These interventions can be embedded into existing health care structures. At the end of the study, Scott and White will institutionalize cost-effective treatment protocols.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Health disparities; Central Texas; PDA; CDSMP

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Measures of HbA1c were collected from electronic health records dating back six months prior to orientation to the last day of study participation (45 days after the 12-month follow-up period). If a participant did not have any HbA1c value within the electronic health record for any particular follow-up visit, a lab test was scheduled to obtain a measure. Of the HbA1c collected six months prior to orientation, the value measured closest to the orientation date was considered as the baseline HbA1c value. HbA1c values that were measured on dates preceding the baseline HbA1c were not included; i.e., HbA1c values included in the analysis were those collected since the baseline HbA1c and until the last day of study participation.

  12 months

Secondary Outcomes (4)

• BMI

  12 months

• Patient Self-reported Perceived Health Status

  12 months

• Diabetes-related Behaviors

  12 months

• Quality of Life (QOL)

  12 months

Study Arms (4)

Personal Digital Assistant

EXPERIMENTAL

Individuals in this arm were taught to use a diabetes self-care software, Diabetes Pilot™ (Digital Altitudes, Arlington Heights, IL), developed for PalmOS® (Palm, Sunnyvale, CA) which was loaded on to compatible PDAs, the Tungsten™ E2 handheld device. The Diabetes Pilot allowed participants to monitor their blood glucose, blood pressure, medication usage, physical activity, and dietary intake by tracking these measures in an electronic diary.

Behavioral: PDA

CDSMP

ACTIVE COMPARATOR

6-week, classroom-based program for diabetes self-management. The CDSMP, developed by Stanford University, equipped participants with the education and skill sets needed to take a more proactive approach in managing their chronic condition(s) and related symptoms.

Behavioral: CDSMP

PDA/CDSMP

ACTIVE COMPARATOR

Combined intervention

Behavioral: PDA/CDSMP

Control

NO INTERVENTION

Usual Care

Interventions

PDA BEHAVIORAL

Technological assistance

Also known as: Personal digital assistant

Personal Digital Assistant

CDSMP BEHAVIORAL

6-week classes

Also known as: Chronic disease self-management program

CDSMP

PDA/CDSMP BEHAVIORAL

Combined technology and education

Also known as: PDA + CDSMP

PDA/CDSMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with T2DM, including those who require insulin therapy, aged \>18 years (eliminates the need to obtain assent for minors who are also dependent on their parents).
• Last measured HbA1c value of \> 7.5% (this study hopes to show an improvement in the control of patient's diabetes, and not focused on patients who already show evidence of good disease control).
• Willingness and ability to attend one initial research visit and semi-annual routine follow-up visits over a 24-month period. The follow-up visits include height, weight, and blood pressure measurement and a survey. Surveys may be conducted by phone interview or mail when a follow-up visit can not be scheduled.
• Ability to read, write, and speak English at least at a grade 8 level so as to be able to engage in self-monitoring and use the commercial diabetes management software program (Diabetes Pilot), which is available only in English. For those with lower-literacy, assistance in filling out forms and understanding required intervention protocols will be provided, and use of a "buddy" will be recommended.

You may not qualify if:

• Not willing to sign an informed consent or be randomized to any of the four treatment/control groups, (we want to minimize any upfront treatment biases, while adhering to human subject protocols).
• Currently, documented severe alcoholism or drug abuse that is \< 6 months ago (concerns that this problem is likely to significantly affect their ability and likelihood to comply with the study requirements over the course of the 24 months).
• Female patients who are pregnant or planning to become pregnant within 12 months (in pregnancy, type 2 diabetes is managed in a completely different manner than in non-pregnant patients).

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• Texas A&M University: collaborator

Study Sites (1)

Scott & White Clinic

Temple, Texas, 76504, United States

Location

Related Publications (7)

• Vuong AM, Huber JC Jr, Bolin JN, Ory MG, Moudouni DM, Helduser J, Begaye D, Bonner TJ, Forjuoh SN. Factors affecting acceptability and usability of technological approaches to diabetes self-management: a case study. Diabetes Technol Ther. 2012 Dec;14(12):1178-82. doi: 10.1089/dia.2012.0139. Epub 2012 Sep 26.

  PMID: 23013155 BACKGROUND

• Appiah B, Hong Y, Ory MG, Helduser JW, Begaye D, Bolin JN, Forjuoh SN. Challenges and opportunities for implementing diabetes self-management guidelines. J Am Board Fam Med. 2013 Jan-Feb;26(1):90-2. doi: 10.3122/jabfm.2013.01.120177.

  PMID: 23288286 BACKGROUND

• Forjuoh SN, Huber C, Bolin JN, Patil SP, Gupta M, Helduser JW, Holleman S, Ory MG. Provision of counseling on diabetes self-management: are there any age disparities? Patient Educ Couns. 2011 Nov;85(2):133-9. doi: 10.1016/j.pec.2010.08.004. Epub 2010 Sep 21.

  PMID: 20863646 RESULT

• Forjuoh SN, Bolin JN, Gupta M, Huber C, Helduser JW, Holleman S, Robertson A, Ory MG. Disparities in diabetes management by race or ethnicity in a primary care clinic in central Texas. Tex Med. 2010 Nov 1;106(11):e1.

  PMID: 21104573 RESULT

• Adepoju OE, Bolin JN, Phillips CD, Zhao H, Ohsfeldt RL, McMaughan DK, Helduser JW, Forjuoh SN. Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model. Patient Educ Couns. 2014 Apr;95(1):111-7. doi: 10.1016/j.pec.2014.01.001. Epub 2014 Jan 13.

  PMID: 24468198 DERIVED

• Forjuoh SN, Bolin JN, Huber JC Jr, Vuong AM, Adepoju OE, Helduser JW, Begaye DS, Robertson A, Moudouni DM, Bonner TJ, McLeroy KR, Ory MG. Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial. BMC Public Health. 2014 Jan 23;14:71. doi: 10.1186/1471-2458-14-71.

  PMID: 24450992 DERIVED

• Adepoju OE, Bolin JN, Ohsfeldt RL, Phillips CD, Zhao H, Ory MG, Forjuoh SN. Can chronic disease management programs for patients with type 2 diabetes reduce productivity-related indirect costs of the disease? Evidence from a randomized controlled trial. Popul Health Manag. 2014 Apr;17(2):112-20. doi: 10.1089/pop.2013.0029. Epub 2013 Oct 23.

  PMID: 24152055 DERIVED

Related Links

• Division of Research, Department of Family \& Community Medicine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Differential dropout across interventions. Failure to obtain 50% minority and 50% non-minority participants, preventing further analyses regarding race/ethnicity differences in outcome. Could only provide information in an exploratory manner.

Results Point of Contact

• Title: Dr. Samuel N. Forjuoh
• Organization: Scott & White Hospital

SFORJUOH@sw.org

(254) 771-7695

Study Officials

• Samuel N Forjuoh, MD MPH DrPH

  Scott & White

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Director of Research

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: January 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 14, 2013
• Results First Posted: October 14, 2013

Record last verified: 2013-08

Locations

US (1)