Clinical trial NCT01145742: Controlling Hypertension in Diabetes- Feasibility Study
Official title: A Collaborative Approach to Control Hypertension in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Hyperlipidemia
Keywords: Type 2 diabetes
Hypertension
Health services research
Health disparities
Behavior change
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-06-17
Enrollment: 56
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes,
* BP above 140/90 on two health center visits,
* home touch tone phone

Exclusion Criteria:

* dementia,
* homelessness,
* language other than English or Spanish

Primary outcomes:
measure: Blood pressure
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: baseline and 6 months
measure: LDL Cholesterol
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Melissa Diane McKee, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: