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Low Indexes of Metabolism - Information to Teams (LIMIT) (LIMIT)

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ClinicalTrials.gov Identifier: NCT02476578
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Nir Tsabar, Clalit Health Services

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Loss Thinness Malnutrition Other: Email Not Applicable

Detailed Description:

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. 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.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75
Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Intervention Email
An email is sent, alerting the primary care providers about low values of BMI, HbA1c% or cholesterol and advising to consider appropriate dietary and medical revision.
Other: Email
Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
Other Name: "Dry Counseling"

No Intervention: Control
No email is sent.



Primary Outcome Measures :
  1. Death from any cause [ Time Frame: 1 year ]
    Impact on overall-survival


Secondary Outcome Measures :
  1. Impact on evaluation rate [ Time Frame: 1 year ]
    Percentage of patients evaluated by a nurse and counseled by a dietician

  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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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/m2 or more during previous two years AND
  • BMI less than 23 Kg/m2 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476578


Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Nir Tsabar, MD/PhD ClalitHS North District Principal Geriatrist

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
LIMIT HEBREW PROTOCOL Version 3 (Final)

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Nir Tsabar, North District Principal Geriatrician, Clalit Health Services
ClinicalTrials.gov Identifier: NCT02476578     History of Changes
Other Study ID Numbers: 0023-15-COM
ר/2015/49 ( Other Grant/Funding Number: The Israel National Institute for Health Policy Research )
METABOL_EMAIL ( Other Identifier: Clalit Health Organization North District Research Group )
0023-15-COM ( Registry Identifier: Clalit Health Organization Community Division )
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Dr. Nir Tsabar, Clalit Health Services:
Hypocholesterolemia
Frail Elderly
Aged
Aged, 80 and over
Cholesterol
Clinical Laboratory Information Systems
Hemoglobin A, Glycosylated
diet therapy
Anticholesteremic Agents
Health Services for the Aged
Hypoglycemic Agents
Hypoglycemia

Additional relevant MeSH terms:
Weight Loss
Malnutrition
Thinness
Body Weight Changes
Body Weight
Signs and Symptoms
Nutrition Disorders