{ "FullStudy":{ "Rank":217704, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517919", "OrgStudyIdInfo":{ "OrgStudyId":"DRDA 90-0893" }, "Organization":{ "OrgFullName":"University of Michigan", "OrgClass":"OTHER" }, "BriefTitle":"Peer-Led Self-Management Support in \"Real World\" Clinical and Community Settings", "OfficialTitle":"Peer-Led Self-Management Support in \"Real World\" Clinical and Community Settings" }, "StatusModule":{ "StatusVerifiedDate":"September 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"September 8, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"September 9, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Rebecca Mase", "ResponsiblePartyInvestigatorTitle":"Michele Heisler, MD", "ResponsiblePartyInvestigatorAffiliation":"University of Michigan" }, "LeadSponsor":{ "LeadSponsorName":"University of Michigan", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"American Academy of Family Physicians", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study will systematically evaluate a training program in state-of-the-art behavioral change approaches and facilitation skills for peer leaders and a peer-led diabetes self-management support program designed to be conducted in community and clinic-based settings on an ongoing basis.", "DetailedDescription":"In phase one we will develop and evaluate a theoretically-driven program to train peer leaders to facilitate longer-term empowerment-based interventions that, when led by health care professionals, have been associated with improved diabetes-related health and psychosocial outcomes.1-8 In phase two we will examine the impact of a sustained peer-led, empowerment-based self-management intervention on improving and maintaining diabetes-related health outcomes. We propose to develop and test the training and program simultaneously in two distinct cultural and linguistic communities with which the team already has strong working relationships and a track record of prior work: African-American (AA) adults in a community-based setting (Ypsilanti, Michigan) and Latino adults (Spanish- and English-speaking) in a clinic-based setting (Southwest Detroit). This will allow us to compare and contrast the translations of the training and program in these two different contexts and to better refine and understand effective methods and develop culturally tailored training and program materials in both English and Spanish." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Diabetes" ] }, "KeywordList":{ "Keyword":[ "peer support", "peer leader", "community health worker", "empowerment", "self-management" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"241", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Intervention: Peer Led Self-Management", "ArmGroupType":"Experimental", "ArmGroupDescription":"Intervention: Peer Led Self-Management (PLSM) involves the DSME program followed by 12 months of peer-led ongoing self-management support", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Peer-Led Self-Management" ] } },{ "ArmGroupLabel":"Diabetes Self-Management Education", "ArmGroupType":"No Intervention", "ArmGroupDescription":"Control: Diabetes Self-Management Education (DSME) involves 12 sessions of self-management training including diabetes education, one-on-one sessions, bi-weekly phone contacts, and preparation for a clinic visit." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Peer-Led Self-Management", "InterventionDescription":"The PLSM intervention is designed to improve and sustain participants' self-management and health-related gains associated with type 2 diabetes. The role of peer leaders is to provide support for (1) ongoing self-management efforts (including the 5-step \"action-planning\" process), (2) psychosocial and emotional adjustment, and (3) linkage to needed health care resources.\n\nPLSM intervention will consist of three main components provided by the Peer Leaders: weekly self-management support sessions; outreach telephone contacts and inbound telephone call from participants.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Intervention: Peer Led Self-Management" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Peer Leadership", "Peer Support" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Changes in clinical, self-care and diabetes-related quality of life from baseline", "PrimaryOutcomeDescription":"Clinical, self-care and diabetes-related quality of life improvements including the following measures: A1c, Summary of Diabetes Self-Care Activities Measure, Diabetes Distress Scale (DDS)", "PrimaryOutcomeTimeFrame":"Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post-completion" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Changes in clinical, self-care and diabetes-related quality of life from baseline", "SecondaryOutcomeDescription":"Clinical, self-care and diabetes-related quality of life improvements including the following measures: lipid levels, blood pressure reading, height and weight, BMI, and satisfaction with care.", "SecondaryOutcomeTimeFrame":"Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post completion" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nthe study will recruit African Americans and Latinos with type 2 diabetes, - at least 21 years old, and\nwho have a regular health care provider, and\nwill commit to attend the 12 session DSME program.\n\nExclusion Criteria:\n\nhaving physical limitations preventing participation, and\nother serious health conditions (e.g., terminal cancer),\nserious psychiatric illness, self-reported excessive alcohol or illicit drug use, and\nserious diabetes complications (e.g., blindness) that would impede meaningful participation in the program", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Michele Heisler, MD, MPA", "OverallOfficialAffiliation":"University of Michigan", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"University of Michigan", "LocationCity":"Ann Arbor", "LocationState":"Michigan", "LocationZip":"48104", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }