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OpenTrials
Completed

NCT Number: NCT00935441

Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes

This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled at Minneapolis VAMC,
  • Type 1 or 2 Diabetes,
  • HbA1c >8.5%,
  • active land-line telephone connection

Exclusion criteria

  • Age >75 years,
  • primary care provider unwilling to have patient enrolled,
  • active dialysis,
  • resident of assisted living facility,
  • research participant in previous diabetes case management study,
  • life expectancy <1 year,
  • severe mental health condition,
  • active substance abuse,
  • pregnant or planning on becoming pregnant

Treatment and study plan

case management with telemonitoring

Behavioral

telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement

usual case management

Behavioral

telephone contact with a case manager

Primary outcomes

  1. Glycemic control (HbA1c)

    Time frame: 9 months after enrollment

Secondary outcomes

  1. Systolic blood pressure control in patients with elevated blood pressure at baseline

    Time frame: 9 months after enrollment

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Official study title

Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2009
Registry last updated
Sep 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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