Skip to main content
OpenTrials
Completed

NCT Number: NCT02476578

Low Indexes of Metabolism - Information to Teams (LIMIT)

The purpose of this study is to determine whether alerting primary care providers by email about low values of BMI, HbA1c% or cholesterol will affect treatment and improve overall survival and other health indexes of people older than 75 years.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Scientific background

Interventions aimed to ameliorate malnutrition are important for elderly health and include dietary counseling and discontinuing unnecessary medicines.

Emailing an alert regarding low BMI was found to improve dietary counseling numbers.

Correlation between death and HbA1c% is U-shaped, with increased mortality under a 6.5% level in patients taking two anti-diabetic medicines. Sending an email alert regarding an over-tight control of diabetes was followed by a reduction in mortality.

Death and cholesterol correlation is also U-shaped, with increased mortality and morbidity under 160 mg%. The investigator found no interventional study for this situation.

Objectives

To check whether alerting the primary care providers by email, about low values of BMI, HbA1c% or cholesterol will affect treatment and improve health indexes of people older than 75 years.

Working hypotheses

During a year, and relative to the control group, intervention emails may result in the following:

  • A decrease in mortality.
  • An increase in dietary counseling percentage and a decrease in prescribing anti-diabetic and cholesterol-lowering medicines.
  • A decrease in medical expenses and in other morbidity indexes.

Type of research and methods of data collection

This randomized controlled trial will be conducted entirely through the existing computer system. The participants (patients) will be assigned to the two Arms/Groups "Intervention Email" and "Control". It has three separate interventions: a. Alerting about a significant drop in BMI. b. Alerting about a low HbA1c% level in patients taking anti-diabetics. c. Alerting about a low cholesterol level in patients taking cholesterol-lowering medicines. The alerts will be sent to the primary clinicians.

Method(s) of data analysis

Differences between intervention groups and control groups will be analyzed using Chi-square test (or Fishers' exact test) for categorical variables and using T-test (or Two-sample Wilcoxon test) for continuous variables.

Uniqueness and relevance

Health service policy regarding signs of malnutrition and excessive medicinal treatment needs a relevant scientific knowledge base. Nutritional counseling and revision of medicinal treatment may dramatically affect health. This research deals with questions that have no commercial interest, but are important to the public.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All found by computerized search in the data base of Clalit Health Services North and South districts:
  • 1. A drop in BMI of 2 Kg/m^2 or more during previous two years AND
  • BMI less than 23 Kg/m^2 AND
  • No dietitian counseling during previous year
  • OR
  • 2. Last HbA1c% level of 6.5% or less AND
  • dispensing anti-diabetic medicines during previous 2 months
  • OR
  • 3. Last total cholesterol less than 160 mg/dL AND
  • dispensing cholesterol-lowering medicines during previous 2 months

Exclusion criteria

  • Patients whose their primary doctor and nurse email address is unobtainable
  • For criterion 3: Patients diagnosed to have had a myocardial infarction, an ischemic heart disease, a transient ischemic attack or an ischemic stroke.

Treatment and study plan

Email

Other

Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.

Other names: "Dry Counseling"

Primary outcomes

  1. Death From Any Cause

    Time frame: 1 year

    Impact on overall-survival

Secondary outcomes

  1. Impact on Evaluation Rate

    Time frame: 1 year

    Percentage of patients evaluated by a nurse and counseled by a dietitian

  2. Impact on Medical Costs

    Time frame: 1 year

    Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.

  3. Impact on a Composite Measure of Medical Treatment

    Time frame: 1 year

    A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.

Sponsors and collaborators

Lead sponsor

Clalit Health Services

Other

Registry information

Official study title

Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75

Acronym: LIMIT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2015
Registry last updated
Apr 9, 2020

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.

Published trials that share one or more normalized conditions with this study.