Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study (DISCO)
26 de marzo de 2014 actualizado por: Medha Munshi, Joslin Diabetes Center
The purpose of this research study is to identify barriers affecting self care in older patients with diabetes and to provide coping strategies for these barriers with help from a care manager (Geriatric Life Specialist) to improve clinical, economical, functional and psychosocial parameters.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a study to evaluate whether short term focused intervention by a geriatric diabetes team, with addition of a care manager, to help overcome barriers to diabetes care in older adults will result in improved clinical, functional, and quality of life measures compared to usual care.
In addition, we will assess whether the support network formed during intervention by the geriatric diabetes team will empower patients, resulting in long lasting improvement in parameters after intervention is completed.
We will also explore whether improved blood glucose control will improve blood circulation in the brain that is compromised in elderly with diabetes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
48
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Joslin Diabetes Center
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Isreal Deaconess Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
69 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 70 years and older
- Diagnosis of type 1 or type 2 diabetes
- Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
- HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
- No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent
Exclusion Criteria:
- Patients with terminal diseases, e.g. malignancy with life expectancy of 12 months or less
- Patients who live more than 25 miles from Joslin Clinic/ Beth Israel Deaconess Medical Center
- Patients who live in an institutional setting, e.g. nursing home, group home, etc
- Patients who are not able to complete outcome assessments,(e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English, etc)
- Patients will be excluded from participation in Study Aim 3 if they have a history of orthostatic hypotension, TIA, or vertebral basilar insufficiency
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Geriatric diabetes team intervention group
The subjects in this group underwent evaluation for barriers to self care by a diabetes educators well versed with age specific barriers.
After consideration of patients clinical, functional, and psychosocial background a geriatric diabetes team devised strategy to help patients cope respective barriers.
A care manager then implemented the coping strategies by educating patients and caregivers.
She also made home visits to assess any safety issues not know to clinic based geriatric team.
She helped the patients and caregivers with all aspects of care coordination.
Patients in this group received phone contact from care managers as many times as needed over the six month intervention period.
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The intervention included developing strategies to help patients cope with their barriers to self care.
The intervention were implemented by care manager over 6 month period in person and by phone calls.
During the six to twelve month period subjects did not have any contact with study staff or care manager.
Otros nombres:
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Sin intervención: Attention Control Group
The subjects in the group received similar, in person, contact as the intervention group.
An educator, separate from the one involved in the intervention team, called patents in this group for a total of eleven time within the first six months.
The phone calls were forces toward general discussion without any diabetes related advice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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change in hemoglobin A1c
Periodo de tiempo: 6 and 12 months
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The primary outcome of the study is to measure change in A1c before and after intervention at 6-months and at 12-months
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6 and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in clinical, functional and psycho social tests and questionnaires
Periodo de tiempo: 6 and 12 months
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Tests, surveys and questionnaires used during study visits are as follows: Demographic and medical history, hypoglycemia history and calendar, medication adherence survey, modified clock making test, trail making test A and B, verbal fluency test, activities of daily living, instrumental activities of daily living, 6 minute walk test, Tinetti test, geriatric depression scale, problem areas in diabetes assessment, self care inventory, determine nutrition test, social support assessment.
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6 and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Medha N Munshi, MD, Joslin Diabetes Center
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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- KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
- Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. doi: 10.2337/diacare.21.4.518.
- Makimattila S, Malmberg-Ceder K, Hakkinen AM, Vuori K, Salonen O, Summanen P, Yki-Jarvinen H, Kaste M, Heikkinen S, Lundbom N, Roine RO. Brain metabolic alterations in patients with type 1 diabetes-hyperglycemia-induced injury. J Cereb Blood Flow Metab. 2004 Dec;24(12):1393-9. doi: 10.1097/01.WCB.0000143700.15489.B2.
- Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, Isham G, Snyder SR, Carande-Kulis VG, Garfield S, Briss P, McCulloch D. The effectiveness of disease and case management for people with diabetes. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):15-38. doi: 10.1016/s0749-3797(02)00423-3.
- Fordyce M, Bardole D, Romer L, Soghikian K, Fireman B. Senior Team Assessment and Referral Program--STAR. J Am Board Fam Pract. 1997 Nov-Dec;10(6):398-406.
- Munshi M, Grande L, Hayes M, Ayres D, Suhl E, Capelson R, Lin S, Milberg W, Weinger K. Cognitive dysfunction is associated with poor diabetes control in older adults. Diabetes Care. 2006 Aug;29(8):1794-9. doi: 10.2337/dc06-0506.
- Blaum CS, Ofstedal MB, Langa KM, Wray LA. Functional status and health outcomes in older americans with diabetes mellitus. J Am Geriatr Soc. 2003 Jun;51(6):745-53. doi: 10.1046/j.1365-2389.2003.51256.x.
- Bertoni AG, Kirk JK, Goff DC Jr, Wagenknecht LE. Excess mortality related to diabetes mellitus in elderly Medicare beneficiaries. Ann Epidemiol. 2004 May;14(5):362-7. doi: 10.1016/j.annepidem.2003.09.004.
- Economic consequences of diabetes mellitus in the U.S. in 1997. American Diabetes Association. Diabetes Care. 1998 Feb;21(2):296-309. doi: 10.2337/diacare.21.2.296.
- Brown AF, Mangione CM, Saliba D, Sarkisian CA; California Healthcare Foundation/American Geriatrics Society Panel on Improving Care for Elders with Diabetes. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc. 2003 May;51(5 Suppl Guidelines):S265-80. doi: 10.1046/j.1532-5415.51.5s.1.x. No abstract available.
- Task Force on Community Preventive Services. Recommendations for healthcare system and self-management education interventions to reduce morbidity and mortality from diabetes. Am J Prev Med. 2002 May;22(4 Suppl):10-4. doi: 10.1016/s0749-3797(02)00422-1. No abstract available.
- Baird TA, Parsons MW, Barber PA, Butcher KS, Desmond PM, Tress BM, Colman PG, Jerums G, Chambers BR, Davis SM. The influence of diabetes mellitus and hyperglycaemia on stroke incidence and outcome. J Clin Neurosci. 2002 Nov;9(6):618-26. doi: 10.1054/jocn.2002.1081.
- Fulesdi B, Limburg M, Bereczki D, Kaplar M, Molnar C, Kappelmayer J, Neuwirth G, Csiba L. Cerebrovascular reactivity and reserve capacity in type II diabetes mellitus. J Diabetes Complications. 1999 Jul-Aug;13(4):191-9. doi: 10.1016/s1056-8727(99)00044-6.
- Griffith DN, Saimbi S, Lewis C, Tolfree S, Betteridge DJ. Abnormal cerebrovascular carbon dioxide reactivity in people with diabetes. Diabet Med. 1987 May-Jun;4(3):217-20. doi: 10.1111/j.1464-5491.1987.tb00865.x.
- Kadoi Y, Hinohara H, Kunimoto F, Saito S, Ide M, Hiraoka H, Kawahara F, Goto F. Diabetic patients have an impaired cerebral vasodilatory response to hypercapnia under propofol anesthesia. Stroke. 2003 Oct;34(10):2399-403. doi: 10.1161/01.STR.0000090471.28672.65. Epub 2003 Sep 4.
- Jimenez-Bonilla JF, Carril JM, Quirce R, Gomez-Barquin R, Amado JA, Gutierrez-Mendiguchia C. Assessment of cerebral blood flow in diabetic patients with no clinical history of neurological disease. Nucl Med Commun. 1996 Sep;17(9):790-4. doi: 10.1097/00006231-199609000-00009.
- MacLeod KM, Gold AE, Ebmeier KP, Hepburn DA, Deary IJ, Goodwin GM, Frier BM. The effects of acute hypoglycemia on relative cerebral blood flow distribution in patients with type I (insulin-dependent) diabetes and impaired hypoglycemia awareness. Metabolism. 1996 Aug;45(8):974-80. doi: 10.1016/s0026-0495(96)90266-8.
- Bean JF, Kiely DK, Leveille SG, Herman S, Huynh C, Fielding R, Frontera W. The 6-minute walk test in mobility-limited elders: what is being measured? J Gerontol A Biol Sci Med Sci. 2002 Nov;57(11):M751-6. doi: 10.1093/gerona/57.11.m751.
- Lord SR, Menz HB. Physiologic, psychologic, and health predictors of 6-minute walk performance in older people. Arch Phys Med Rehabil. 2002 Jul;83(7):907-11. doi: 10.1053/apmr.2002.33227.
- Bautmans I, Lambert M, Mets T. The six-minute walk test in community dwelling elderly: influence of health status. BMC Geriatr. 2004 Jul 23;4:6. doi: 10.1186/1471-2318-4-6.
- Montorio I, Izal M. The Geriatric Depression Scale: a review of its development and utility. Int Psychogeriatr. 1996 Spring;8(1):103-12. doi: 10.1017/s1041610296002505.
- Welch G, Weinger K, Anderson B, Polonsky WH. Responsiveness of the Problem Areas In Diabetes (PAID) questionnaire. Diabet Med. 2003 Jan;20(1):69-72. doi: 10.1046/j.1464-5491.2003.00832.x.
- Tiecks FP, Lam AM, Aaslid R, Newell DW. Comparison of static and dynamic cerebral autoregulation measurements. Stroke. 1995 Jun;26(6):1014-9. doi: 10.1161/01.str.26.6.1014.
- Panerai RB. Assessment of cerebral pressure autoregulation in humans--a review of measurement methods. Physiol Meas. 1998 Aug;19(3):305-38. doi: 10.1088/0967-3334/19/3/001.
- Aaslid R, Newell DW, Stooss R, Sorteberg W, Lindegaard KF. Assessment of cerebral autoregulation dynamics from simultaneous arterial and venous transcranial Doppler recordings in humans. Stroke. 1991 Sep;22(9):1148-54. doi: 10.1161/01.str.22.9.1148.
- Zhang R, Zuckerman JH, Giller CA, Levine BD. Transfer function analysis of dynamic cerebral autoregulation in humans. Am J Physiol. 1998 Jan;274(1 Pt 2):H233-41. doi: 10.1152/ajpheart.1998.274.1.h233.
- Panerai RB, Dawson SL, Potter JF. Linear and nonlinear analysis of human dynamic cerebral autoregulation. Am J Physiol. 1999 Sep;277(3):H1089-99. doi: 10.1152/ajpheart.1999.277.3.H1089.
- Benarroch EE, S.P., Low PA, The Valsalva Manuever. In Clinical Autonomic Disroders: Evaluation and Management, L.P. editor, Editor. 1993, Little Brown and company: Boston. p. 209-215.
- Rutan GH, Hermanson B, Bild DE, Kittner SJ, LaBaw F, Tell GS. Orthostatic hypotension in older adults. The Cardiovascular Health Study. CHS Collaborative Research Group. Hypertension. 1992 Jun;19(6 Pt 1):508-19. doi: 10.1161/01.hyp.19.6.508.
- Low, P.A., Laboratory Evaluation of Autonomic Function. In Clinical Autonomic Disorders, P.A. Low, Editor. 1997, LIppincott-Raven: Philadelphia. p. 179-208.
- Novak V, Chowdhary A, Farrar B, Nagaraja H, Braun J, Kanard R, Novak P, Slivka A. Altered cerebral vasoregulation in hypertension and stroke. Neurology. 2003 May 27;60(10):1657-63. doi: 10.1212/01.wnl.0000068023.14587.06.
- Greenfield JC Jr, Rembert JC, Tindall GT. Transient changes in cerebral vascular resistance during the Valsalva maneuver in man. Stroke. 1984 Jan-Feb;15(1):76-9. doi: 10.1161/01.str.15.1.76.
- Werner C, Kochs E, Hoffman WE, Blanc IF, Schulte am Esch J. Cerebral blood flow and cerebral blood flow velocity during angiotensin-induced arterial hypertension in dogs. Can J Anaesth. 1993 Aug;40(8):755-60. doi: 10.1007/BF03009772.
- Munshi MN, Segal AR, Suhl E, Ryan C, Sternthal A, Giusti J, Lee Y, Fitzgerald S, Staum E, Bonsignor P, DesRochers L, McCartney R, Weinger K. Assessment of barriers to improve diabetes management in older adults: a randomized controlled study. Diabetes Care. 2013 Mar;36(3):543-9. doi: 10.2337/dc12-1303. Epub 2012 Nov 27.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2006
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
16 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
23 de noviembre de 2011
Publicado por primera vez (Estimar)
29 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
28 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
26 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 06-15
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