Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT01480804
Status:
COMPLETED
Last Update Posted:
2014-03-28
First Post:
2011-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D000085542', 'term': 'Functional Status'}, {'id': 'D004467', 'term': 'Economics'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000203', 'term': 'Activities of Daily Living'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-26', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in hemoglobin A1c', 'timeFrame': '6 and 12 months', 'description': 'The primary outcome of the study is to measure change in A1c before and after intervention at 6-months and at 12-months'}], 'secondaryOutcomes': [{'measure': 'Change in clinical, functional and psycho social tests and questionnaires', 'timeFrame': '6 and 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Barriers', 'Intervention', 'Elderly', 'glycemic control'], 'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '15625413', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11985933', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9407480', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16873782', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9571335', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12757559', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15177276', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9539999', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12694461', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11985932', 'type': 'BACKGROUND', 'citation': 'Task Force on Community Preventive Services. Recommendations for healthcare system and self-management education interventions to reduce morbidity and mortality from diabetes. 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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.'}, {'pmid': '14044222', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12403805', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12098148', 'type': 'BACKGROUND', 'citation': 'Lord SR, Menz HB. 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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.'}, {'type': 'BACKGROUND', 'citation': 'Low, P.A., Laboratory Evaluation of Autonomic Function. In Clinical Autonomic Disorders, P.A. Low, Editor. 1997, LIppincott-Raven: Philadelphia. p. 179-208.'}, {'pmid': '12771258', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '6229907', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8403159', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23193208', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '69 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 70 years and older\n* Diagnosis of type 1 or type 2 diabetes\n* Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year\n* HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)\n* No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent\n\nExclusion Criteria:\n\n* Patients with terminal diseases, e.g. malignancy with life expectancy of 12 months or less\n* Patients who live more than 25 miles from Joslin Clinic/ Beth Israel Deaconess Medical Center\n* Patients who live in an institutional setting, e.g. nursing home, group home, etc\n* 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)\n* Patients will be excluded from participation in Study Aim 3 if they have a history of orthostatic hypotension, TIA, or vertebral basilar insufficiency'}, 'identificationModule': {'nctId': 'NCT01480804', 'acronym': 'DISCO', 'briefTitle': 'Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study', 'orgStudyIdInfo': {'id': '06-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Geriatric diabetes team intervention group', 'description': '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.', 'interventionNames': ['Other: Intervention for age specific barriers to self care']}, {'type': 'NO_INTERVENTION', 'label': 'Attention Control Group', 'description': '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.'}], 'interventions': [{'name': 'Intervention for age specific barriers to self care', 'type': 'OTHER', 'otherNames': ['Clinical', 'Functional', 'Psychosocial', 'Economic'], 'description': '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.', 'armGroupLabels': ['Geriatric diabetes team intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Isreal Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Medha N Munshi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Geriactric Diabetes Clinic', 'investigatorFullName': 'Medha Munshi', 'investigatorAffiliation': 'Joslin Diabetes Center'}}}}