Financial Incentives and Text Messaging to Improve African American Womens' Glycemic Control

NCT02384265 | Completed

• 1 other identifier: 1P60MD006923
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a major public health problem that is associated with substantial health disparities for African American women compared to African American men or white men and women. This project will incorporate a) new technology whose use is high among African Americans (cell phone text message reminders), b) support from social networks, and c) strategies from the emerging field of behavioral economics to encourage and support self care behaviors that lead to improvements in diabetes control. In Stage I of the study, the investigators conducted focus groups with women with diabetes and their family members and friends. The investigators used information from these groups to work with a team of community partners to develop recruitment protocols, prepare study documents (including flyers, Frequently Asked Questions sheets, and informed consent forms), and finalize participant surveys. In the next phase of the study the investigators will evaluate ways that friends and family members can use direct support and text messages to improve control of blood sugar for African American women with type 2 diabetes. A team of three people--the Person With Diabetes (PWD) and 2 friends or family members, also known as the Support Team Members (STMs)--will be assigned at random to one of two groups to compare approaches to improving control of blood sugar. Each team will receive information and resources on improving diabetes control and will be linked by a text messaging program. The intervention team will receive additional text messaging support that may help them improve the PWD's diabetes control.

Conditions

Diabetes Mellitus

Keywords

Diabetes; Disparities; Behavioral; Text messaging; Social networks; African American; Female

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hemoglobin A1c at 12-months

  The investigators will measure the change in hemoglobin A1c (measured as % A1c).

  12-months

Secondary Outcomes (4)

• Change from Baseline in Weight 12-months

  12 months

• Change from Baseline in Body Mass Index at 12-months

  12 months

• Change from Baseline in Waist Circumference (inches) at 12-months

  12 months

• Change from Baseline in Systolic and Diastolic Blood Pressure at 12-months

  12 months

Study Arms (2)

IM/SMS + Incentive Condition

EXPERIMENTAL

Participants in the intervention condition will consist of the PWD and their two STMs. The PWD and STM will receive the same protocols that the "Usual Care" participants receive, including an introductory educational session, written materials on diabetes, a blood glucose log, and a physical activity monitoring log. The PWDs in this condition will also receive training in action planning with their STMs. They will also receive SMS messages supporting diabetes self-care from the study team. The study team will also encourage the STMs to interaction in person and via text messages with the PWD.

Behavioral: IM/SMS + Incentive Condition

Control

NO INTERVENTION

Control group participants will consist of the person with diabetes (PWD) and their two support team members (STM). The PWD will receive regular medical care from their usual providers. They will also receive an introductory educational session and written materials on diabetes, the importance of its control, and diabetes self-care strategies, and a blood glucose and physical activity monitoring log. They will be invited for study visits at 3, 6, and 12 months to measure cholesterol, A1c (for those with diabetes), blood pressure, height, and weight measurement. PWDs and STMs in the control condition will receive generic health promotion information during in-person visits or by mail. They will receive follow-up messages by text to remind them about study related events.

Interventions

IM/SMS + Incentive Condition BEHAVIORAL

See description of Intervention arm protocols above.

IM/SMS + Incentive Condition

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible persons with diabetes (PWDs) will be identified either through the clinic diabetes registry, referrals from their providers, or direct recruitment by study staff during clinic hours. Eligible subjects are African American women seen at the clinic at least once in the prior 12 months, who have a record of at least one A1c reading in the past year (most recent A1c \>8%), indicate that they plan to receive their diabetes care from the clinic over the next 18 months, and have a cell phone with an active plan, have two other individuals who they identify as friends or family members to enroll with them.
• Eligible support team members (STMs) will be identified by the PWD as being a friend or family member 18 years or older and have a cell phone with an active plan.

You may not qualify if:

• The investigators will exclude PWDs who are pregnant at the time of enrollment or those who only had diabetes during pregnancy, children, prisoners, homeless persons, institutionalized adults, and adults with type 1 diabetes, hemophilia, AIDS, cancer, hemoglobinopathies, or severe mental illness.
• The investigators will exclude STMs who are younger than 18 years old or do not have a cell phone with an active plan.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Holman United Methodist Church

Los Angeles, California, 90018, United States

Location

Related Publications (83)

• Sacks DB, Bruns DE, Goldstein DE, Maclaren NK, McDonald JM, Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem. 2002 Mar;48(3):436-72.

  PMID: 11861436 BACKGROUND

• Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, Hadden D, Turner RC, Holman RR. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.

  PMID: 10938048 BACKGROUND

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):854-65.

  PMID: 9742977 BACKGROUND

• Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995 May;28(2):103-17. doi: 10.1016/0168-8227(95)01064-k.

  PMID: 7587918 BACKGROUND

• Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, Meigs JB, Ross-Degnan D. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007 Apr;30(4):807-12. doi: 10.2337/dc06-2170. Epub 2007 Jan 26.

  PMID: 17259469 BACKGROUND

• Grant RW, Cagliero E, Dubey AK, Gildesgame C, Chueh HC, Barry MJ, Singer DE, Nathan DM, Meigs JB. Clinical inertia in the management of Type 2 diabetes metabolic risk factors. Diabet Med. 2004 Feb;21(2):150-5. doi: 10.1111/j.1464-5491.2004.01095.x.

  PMID: 14984450 BACKGROUND

• Brown AF, Gregg EW, Stevens MR, Karter AJ, Weinberger M, Safford MM, Gary TL, Caputo DA, Waitzfelder B, Kim C, Beckles GL. Race, ethnicity, socioeconomic position, and quality of care for adults with diabetes enrolled in managed care: the Translating Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2005 Dec;28(12):2864-70. doi: 10.2337/diacare.28.12.2864.

  PMID: 16306546 BACKGROUND

• Heisler M, Smith DM, Hayward RA, Krein SL, Kerr EA. Racial disparities in diabetes care processes, outcomes, and treatment intensity. Med Care. 2003 Nov;41(11):1221-32. doi: 10.1097/01.MLR.0000093421.64618.9C.

  PMID: 14583685 BACKGROUND

• Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999 Mar;22(3):403-8. doi: 10.2337/diacare.22.3.403.

  PMID: 10097918 BACKGROUND

• Karter AJ, Ferrara A, Liu JY, Moffet HH, Ackerson LM, Selby JV. Ethnic disparities in diabetic complications in an insured population. JAMA. 2002 May 15;287(19):2519-27. doi: 10.1001/jama.287.19.2519.

  PMID: 12020332 BACKGROUND

• Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.

  PMID: 17881626 BACKGROUND

• Sequist TD, Fitzmaurice GM, Marshall R, Shaykevich S, Marston A, Safran DG, Ayanian JZ. Cultural competency training and performance reports to improve diabetes care for black patients: a cluster randomized, controlled trial. Ann Intern Med. 2010 Jan 5;152(1):40-6. doi: 10.7326/0003-4819-152-1-201001050-00009.

  PMID: 20048271 BACKGROUND

• Lussier JP, Heil SH, Mongeon JA, Badger GJ, Higgins ST. A meta-analysis of voucher-based reinforcement therapy for substance use disorders. Addiction. 2006 Feb;101(2):192-203. doi: 10.1111/j.1360-0443.2006.01311.x.

  PMID: 16445548 BACKGROUND

• Malotte CK, Rhodes F, Mais KE. Tuberculosis screening and compliance with return for skin test reading among active drug users. Am J Public Health. 1998 May;88(5):792-6. doi: 10.2105/ajph.88.5.792.

  PMID: 9585747 BACKGROUND

• Seal KH, Kral AH, Lorvick J, McNees A, Gee L, Edlin BR. A randomized controlled trial of monetary incentives vs. outreach to enhance adherence to the hepatitis B vaccine series among injection drug users. Drug Alcohol Depend. 2003 Aug 20;71(2):127-31. doi: 10.1016/s0376-8716(03)00074-7.

  PMID: 12927650 BACKGROUND

• Stevens-Simon C, O'Connor P, Bassford K. Incentives enhance postpartum compliance among adolescent prenatal patients. J Adolesc Health. 1994 Jul;15(5):396-9. doi: 10.1016/1054-139x(94)90263-1.

  PMID: 7947854 BACKGROUND

• Donatelle R, Hudson D, Dobie S, Goodall A, Hunsberger M, Oswald K. Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S163-79. doi: 10.1080/14622200410001669196.

  PMID: 15203819 BACKGROUND

• Hey K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004307. doi: 10.1002/14651858.CD004307.pub2.

  PMID: 15846705 BACKGROUND

• Volpp KG, Troxel AB, Pauly MV, Glick HA, Puig A, Asch DA, Galvin R, Zhu J, Wan F, DeGuzman J, Corbett E, Weiner J, Audrain-McGovern J. A randomized, controlled trial of financial incentives for smoking cessation. N Engl J Med. 2009 Feb 12;360(7):699-709. doi: 10.1056/NEJMsa0806819.

  PMID: 19213683 BACKGROUND

• Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.

  PMID: 19102784 BACKGROUND

• Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.

  PMID: 19066383 BACKGROUND

• Curry SJ, Wagner EH, Grothaus LC. Evaluation of intrinsic and extrinsic motivation interventions with a self-help smoking cessation program. J Consult Clin Psychol. 1991 Apr;59(2):318-24. doi: 10.1037//0022-006x.59.2.318.

  PMID: 2030194 BACKGROUND

• Williams GC, Gagne M, Ryan RM, Deci EL. Facilitating autonomous motivation for smoking cessation. Health Psychol. 2002 Jan;21(1):40-50.

  PMID: 11846344 BACKGROUND

• Williams GC, McGregor HA, Zeldman A, Freedman ZR, Deci EL. Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol. 2004 Jan;23(1):58-66. doi: 10.1037/0278-6133.23.1.58.

  PMID: 14756604 BACKGROUND

• Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040.

  PMID: 19135907 BACKGROUND

• Cowie CC, Rust KF, Ford ES, Eberhardt MS, Byrd-Holt DD, Li C, Williams DE, Gregg EW, Bainbridge KE, Saydah SH, Geiss LS. Full accounting of diabetes and pre-diabetes in the U.S. population in 1988-1994 and 2005-2006. Diabetes Care. 2009 Feb;32(2):287-94. doi: 10.2337/dc08-1296. Epub 2008 Nov 18.

  PMID: 19017771 BACKGROUND

• Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group; Lachin JM, Genuth S, Cleary P, Davis MD, Nathan DM. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med. 2000 Feb 10;342(6):381-9. doi: 10.1056/NEJM200002103420603.

  PMID: 10666428 BACKGROUND

• Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med. 2008 Oct 9;359(15):1577-89. doi: 10.1056/NEJMoa0806470. Epub 2008 Sep 10.

  PMID: 18784090 BACKGROUND

• Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.

  PMID: 16371630 BACKGROUND

• Brown AF, Gerzoff RB, Karter AJ, Gregg E, Safford M, Waitzfelder B, Beckles GL, Brusuelas R, Mangione CM; TRIAD Study Group. Health behaviors and quality of care among Latinos with diabetes in managed care. Am J Public Health. 2003 Oct;93(10):1694-8. doi: 10.2105/ajph.93.10.1694.

  PMID: 14534224 BACKGROUND

• Heisler M, Faul JD, Hayward RA, Langa KM, Blaum C, Weir D. Mechanisms for racial and ethnic disparities in glycemic control in middle-aged and older Americans in the health and retirement study. Arch Intern Med. 2007 Sep 24;167(17):1853-60. doi: 10.1001/archinte.167.17.1853.

  PMID: 17893306 BACKGROUND

• Duru OK, Gerzoff RB, Selby JV, Brown AF, Ackermann RT, Karter AJ, Ross S, Steers N, Herman WH, Waitzfelder B, Mangione CM. Identifying risk factors for racial disparities in diabetes outcomes: the translating research into action for diabetes study. Med Care. 2009 Jun;47(6):700-6. doi: 10.1097/mlr.0b013e318192609d.

  PMID: 19480090 BACKGROUND

• Hofer TP, Hayward RA, Greenfield S, Wagner EH, Kaplan SH, Manning WG. The unreliability of individual physician "report cards" for assessing the costs and quality of care of a chronic disease. JAMA. 1999 Jun 9;281(22):2098-105. doi: 10.1001/jama.281.22.2098.

  PMID: 10367820 BACKGROUND

• Krein SL, Hofer TP, Kerr EA, Hayward RA. Whom should we profile? Examining diabetes care practice variation among primary care providers, provider groups, and health care facilities. Health Serv Res. 2002 Oct;37(5):1159-80. doi: 10.1111/1475-6773.01102.

  PMID: 12479491 BACKGROUND

• Piette JD, Heisler M, Harand A, Juip M. Beliefs about prescription medications among patients with diabetes: variation across racial groups and influences on cost-related medication underuse. J Health Care Poor Underserved. 2010 Feb;21(1):349-61. doi: 10.1353/hpu.0.0247.

  PMID: 20173274 BACKGROUND

• Coleman K, Reiter KL, Fulwiler D. The impact of pay-for-performance on diabetes care in a large network of community health centers. J Health Care Poor Underserved. 2007 Nov;18(4):966-83. doi: 10.1353/hpu.2007.0090.

  PMID: 17982218 BACKGROUND

• Millett C, Gray J, Bottle A, Majeed A. Ethnic disparities in blood pressure management in patients with hypertension after the introduction of pay for performance. Ann Fam Med. 2008 Nov-Dec;6(6):490-6. doi: 10.1370/afm.907.

  PMID: 19001300 BACKGROUND

• Millett C, Gray J, Saxena S, Netuveli G, Khunti K, Majeed A. Ethnic disparities in diabetes management and pay-for-performance in the UK: the Wandsworth Prospective Diabetes Study. PLoS Med. 2007 Jun;4(6):e191. doi: 10.1371/journal.pmed.0040191.

  PMID: 17564486 BACKGROUND

• Millett C, Netuveli G, Saxena S, Majeed A. Impact of pay for performance on ethnic disparities in intermediate outcomes for diabetes: a longitudinal study. Diabetes Care. 2009 Mar;32(3):404-9. doi: 10.2337/dc08-0912. Epub 2008 Dec 10.

  PMID: 19073759 BACKGROUND

• Deci EL, Koestner R, Ryan RM. A meta-analytic review of experiments examining the effects of extrinsic rewards on intrinsic motivation. Psychol Bull. 1999 Nov;125(6):627-68; discussion 692-700. doi: 10.1037/0033-2909.125.6.627.

  PMID: 10589297 BACKGROUND

• Deci EL, Ryan RM. Intrinsic Motivation and Self-Determination in Human Behavior (Perspectives in Social Psychology). New York: Plenum Press; 1985.

  BACKGROUND

• Greene D, Lepper MR. Effects of extrinsic rewards on children's subsequent intrinsic interest. Child Dev. 1974 Dec;45(4):1141-5. No abstract available.

  PMID: 4143868 BACKGROUND

• Lorence D, Park H. Group disparities and health information: a study of online access for the underserved. Health Informatics J. 2008 Mar;14(1):29-38. doi: 10.1177/1460458207086332.

  PMID: 18258673 BACKGROUND

• Lorence DP, Park H, Fox S. Racial disparities in health information access: resilience of the Digital Divide. J Med Syst. 2006 Aug;30(4):241-9. doi: 10.1007/s10916-005-9003-y.

  PMID: 16978003 BACKGROUND

• Brown AF. Patient, system and clinician level interventions to address disparities in diabetes care. Curr Diabetes Rev. 2007 Nov;3(4):244-8. doi: 10.2174/157339907782329988.

  PMID: 18220681 BACKGROUND

• Berger CC. Control of color of crowns for pulpless anterior teeth. J Prosthet Dent. 1968 Jan;19(1):58-9. doi: 10.1016/0022-3913(68)90010-3. No abstract available.

  PMID: 5234948 BACKGROUND

• Duru OK, Mangione CM, Steers NW, Herman WH, Karter AJ, Kountz D, Marrero DG, Safford MM, Waitzfelder B, Gerzoff RB, Huh S, Brown AF; TRIAD Study Group. The association between clinical care strategies and the attenuation of racial/ethnic disparities in diabetes care: the Translating Research Into Action for Diabetes (TRIAD) Study. Med Care. 2006 Dec;44(12):1121-8. doi: 10.1097/01.mlr.0000237423.05294.c0.

  PMID: 17122717 BACKGROUND

• Ettner SL, Cadwell BL, Russell LB, Brown A, Karter AJ, Safford M, Mangione C, Beckles G, Herman WH, Thompson TJ; TRIAD Study Group. Investing time in health: do socioeconomically disadvantaged patients spend more or less extra time on diabetes self-care? Health Econ. 2009 Jun;18(6):645-63. doi: 10.1002/hec.1394.

  PMID: 18709636 BACKGROUND

• Gary TL, Safford MM, Gerzoff RB, Ettner SL, Karter AJ, Beckles GL, Brown AF. Perception of neighborhood problems, health behaviors, and diabetes outcomes among adults with diabetes in managed care: the Translating Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2008 Feb;31(2):273-8. doi: 10.2337/dc07-1111. Epub 2007 Nov 13.

  PMID: 18000180 BACKGROUND

• Gregg EW, Karter AJ, Gerzoff RB, Safford M, Brown AF, Tseng CW, Waitzfielder B, Herman WH, Mangione CM, Selby JV, Thompson TJ, Dudley RA. Characteristics of insured patients with persistent gaps in diabetes care services: the Translating Research into Action for Diabetes (TRIAD) study. Med Care. 2010 Jan;48(1):31-7. doi: 10.1097/MLR.0b013e3181bd4783.

  PMID: 20009778 BACKGROUND

• Karter AJ, Stevens MR, Brown AF, Duru OK, Gregg EW, Gary TL, Beckles GL, Tseng CW, Marrero DG, Waitzfelder B, Herman WH, Piette JD, Safford MM, Ettner SL. Educational disparities in health behaviors among patients with diabetes: the Translating Research Into Action for Diabetes (TRIAD) Study. BMC Public Health. 2007 Oct 29;7:308. doi: 10.1186/1471-2458-7-308.

  PMID: 17967177 BACKGROUND

• Karter AJ, Stevens MR, Gregg EW, Brown AF, Tseng CW, Marrero DG, Duru OK, Gary TL, Piette JD, Waitzfelder B, Herman WH, Beckles GL, Safford MM, Ettner SL. Educational disparities in rates of smoking among diabetic adults: the translating research into action for diabetes study. Am J Public Health. 2008 Feb;98(2):365-70. doi: 10.2105/AJPH.2005.083501. Epub 2007 Jun 28.

  PMID: 17600269 BACKGROUND

• Karter AJ, Stevens MR, Herman WH, Ettner S, Marrero DG, Safford MM, Engelgau MM, Curb JD, Brown AF; Translating Research Into Action for Diabetes Study Group. Out-of-pocket costs and diabetes preventive services: the Translating Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2003 Aug;26(8):2294-9. doi: 10.2337/diacare.26.8.2294.

  PMID: 12882851 BACKGROUND

• Mangione CM, Gerzoff RB, Williamson DF, Steers WN, Kerr EA, Brown AF, Waitzfelder BE, Marrero DG, Dudley RA, Kim C, Herman W, Thompson TJ, Safford MM, Selby JV; TRIAD Study Group. The association between quality of care and the intensity of diabetes disease management programs. Ann Intern Med. 2006 Jul 18;145(2):107-16. doi: 10.7326/0003-4819-145-2-200607180-00008.

  PMID: 16847293 BACKGROUND

• Selby JV, Swain BE, Gerzoff RB, Karter AJ, Waitzfelder BE, Brown AF, Ackermann RT, Duru OK, Ferrara A, Herman W, Marrero DG, Caputo D, Narayan KM; TRIAD Study Group. Understanding the gap between good processes of diabetes care and poor intermediate outcomes: Translating Research into Action for Diabetes (TRIAD). Med Care. 2007 Dec;45(12):1144-53. doi: 10.1097/MLR.0b013e3181468e79.

  PMID: 18007164 BACKGROUND

• TRIAD Study Group. The Translating Research Into Action for Diabetes (TRIAD) study: a multicenter study of diabetes in managed care. Diabetes Care. 2002 Feb;25(2):386-9. doi: 10.2337/diacare.25.2.386. No abstract available.

  PMID: 11815515 BACKGROUND

• Arsie MP, Marchioro L, Lapolla A, Giacchetto GF, Bordin MR, Rizzotti P, Fedele D. Evaluation of diagnostic reliability of DCA 2000 for rapid and simple monitoring of HbA1c. Acta Diabetol. 2000 Mar;37(1):1-7. doi: 10.1007/s005920070028.

  PMID: 10928229 BACKGROUND

• Lenters-Westra E, Slingerland RJ. Six of eight hemoglobin A1c point-of-care instruments do not meet the general accepted analytical performance criteria. Clin Chem. 2010 Jan;56(1):44-52. doi: 10.1373/clinchem.2009.130641. Epub 2009 Nov 19.

  PMID: 19926777 BACKGROUND

• Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

  PMID: 847061 BACKGROUND

• Hackman J, Oldham G. Motivation through Design of Work-Test of a Theory. Organizational Behavior and Human Performance. 1976 1976;16:250-279.

  BACKGROUND

• Heath C, Larrick RP, Wu G. Goals as reference points. Cogn Psychol. 1999 Feb;38(1):79-109. doi: 10.1006/cogp.1998.0708.

  PMID: 10090799 BACKGROUND

• Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P. New medication adherence scale versus pharmacy fill rates in seniors with hypertension. Am J Manag Care. 2009 Jan;15(1):59-66.

  PMID: 19146365 BACKGROUND

• Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

  PMID: 18453793 BACKGROUND

• Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.

  PMID: 3945130 BACKGROUND

• Babamoto KS, Sey KA, Camilleri AJ, Karlan VJ, Catalasan J, Morisky DE. Improving diabetes care and health measures among hispanics using community health workers: results from a randomized controlled trial. Health Educ Behav. 2009 Feb;36(1):113-26. doi: 10.1177/1090198108325911.

  PMID: 19188371 BACKGROUND

• Cohen JL, Mann DM, Wisnivesky JP, Home R, Leventhal H, Musumeci-Szabo TJ, Halm EA. Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the Medication Adherence Report Scale for Asthma. Ann Allergy Asthma Immunol. 2009 Oct;103(4):325-31. doi: 10.1016/s1081-1206(10)60532-7.

  PMID: 19852197 BACKGROUND

• Kripalani S, Risser J, Gatti ME, Jacobson TA. Development and evaluation of the Adherence to Refills and Medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health. 2009 Jan-Feb;12(1):118-23. doi: 10.1111/j.1524-4733.2008.00400.x.

  PMID: 19911444 BACKGROUND

• Hibbard JH, Mahoney E. Toward a theory of patient and consumer activation. Patient Educ Couns. 2010 Mar;78(3):377-81. doi: 10.1016/j.pec.2009.12.015. Epub 2010 Feb 25.

  PMID: 20188505 BACKGROUND

• Hibbard JH, Mahoney ER, Stock R, Tusler M. Do increases in patient activation result in improved self-management behaviors? Health Serv Res. 2007 Aug;42(4):1443-63. doi: 10.1111/j.1475-6773.2006.00669.x.

  PMID: 17610432 BACKGROUND

• Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918-30. doi: 10.1111/j.1475-6773.2005.00438.x.

  PMID: 16336556 BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Anderson RM, Funnell MM, Fitzgerald JT, Marrero DG. The Diabetes Empowerment Scale: a measure of psychosocial self-efficacy. Diabetes Care. 2000 Jun;23(6):739-43. doi: 10.2337/diacare.23.6.739.

  PMID: 10840988 BACKGROUND

• Anderson RM, Funnell MM, Nwankwo R, Gillard ML, Oh M, Fitzgerald JT. Evaluating a problem-based empowerment program for African Americans with diabetes: results of a randomized controlled trial. Ethn Dis. 2005 Autumn;15(4):671-8.

  PMID: 16259492 BACKGROUND

• Tang TS, Funnell MM, Brown MB, Kurlander JE. Self-management support in "real-world" settings: an empowerment-based intervention. Patient Educ Couns. 2010 May;79(2):178-84. doi: 10.1016/j.pec.2009.09.029. Epub 2009 Nov 3.

  PMID: 19889508 BACKGROUND

• Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.

  PMID: 12716841 BACKGROUND

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• Cleary PD, Jette AM. The validity of self-reported physician utilization measures. Med Care. 1984 Sep;22(9):796-803. doi: 10.1097/00005650-198409000-00003.

  PMID: 6492908 BACKGROUND

• Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001 Feb;54(2):136-41. doi: 10.1016/s0895-4356(00)00261-4.

  PMID: 11166528 BACKGROUND

• Reijneveld SA, Stronks K. The validity of self-reported use of health care across socioeconomic strata: a comparison of survey and registration data. Int J Epidemiol. 2001 Dec;30(6):1407-14. doi: 10.1093/ije/30.6.1407.

  PMID: 11821355 BACKGROUND

• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.

  PMID: 15343421 BACKGROUND

• Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999 Sep;38(1):33-42. doi: 10.1016/s0738-3991(98)00116-5.

  PMID: 14528569 BACKGROUND

• Davis TC, Michielutte R, Askov EN, Williams MV, Weiss BD. Practical assessment of adult literacy in health care. Health Educ Behav. 1998 Oct;25(5):613-24. doi: 10.1177/109019819802500508.

  PMID: 9768381 BACKGROUND

Related Links

• Cellular Telecommunications and Internet Association. Semi-Annual Wireless Industry survey. Washington 2006.
• Smith A. Mobile Access 2010. Pew Internet and American Life Project. 2010
• Fox S. Mobile Health 2010. Pew Internet and American Life Project. 2010

MeSH Terms

Conditions

Diabetes Mellitus; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Arleen F Brown, M.D., Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 10, 2015
• Study Start: June 21, 2012
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)