Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study (DISCO)
26. marts 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
48
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Joslin Diabetes Center
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Boston, Massachusetts, Forenede Stater, 02215
- Beth Isreal Deaconess Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
69 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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change in hemoglobin A1c
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in clinical, functional and psycho social tests and questionnaires
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Medha N Munshi, MD, Joslin Diabetes Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- 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.
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- 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.
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2006
Primær færdiggørelse (Faktiske)
1. december 2012
Studieafslutning (Faktiske)
1. december 2012
Datoer for studieregistrering
Først indsendt
16. november 2011
Først indsendt, der opfyldte QC-kriterier
23. november 2011
Først opslået (Skøn)
29. november 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. marts 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. marts 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06-15
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Kliniske forsøg med Intervention for age specific barriers to self care
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