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BMC Health Services Research
Published in: BMC Health Services Research 1/2018

Open Access 01-12-2018 | Study protocol

The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older

Authors: Nir Tsabar, Yan Press, Johanna Rotman, Bracha Klein, Yonatan Grossman, Maya Vainshtein-Tal, Sophia Eilat-Tsanani

Published in: BMC Health Services Research | Issue 1/2018

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Abstract

Background

Too-low body mass index (BMI), HbA1c% or cholesterol levels predicts poor survival. This study investigates whether e-mails about these low values, improve health of people older than 75 years.

Methods

LIMIT - an open label randomized trial - compares usual care to the addition of an e-mail which alerts the family physicians and nurses to low metabolic indexes of a specific patient and advises on nutritional and medical changes. Participants: Clalit Health Services (CHS) patients in the Northern and Southern Districts, aged ≥75 years with any of the following inclusion criteria: a. Significant weight loss: BMI < 23 kg/m2 with BMI drop of ≥2 kg/m2 during previous two years and without dietitian counseling during previous year. b. Tight diabetic control: HbA1c% ≤ 6.5% and received anti-diabetic medicines during previous 2 months. c. Drug associated hypocholesterolemia: total cholesterol <160 mg/dL and received cholesterol-lowering medicines during previous 2 months. Excluded from criterion c, were patients diagnosed with either ischemic heart disease, transient ischemic attack or stroke. The primary outcome was death from any cause, within one year. In a population of 48,623 people over the age of 75 years, 8584 (17.7%) patients were identified with low metabolic indices and were randomized to intervention or control groups. E-mails were sent on November 2015 to physicians and nurses at 383 clinics.

Discussion

Low metabolic reserve is common in people in Israel’s peripheral districts aged ≥75 years. LIMIT may show whether alerting primary care staff is beneficial.

Trial registration

ClinicalTrials.gov NCT02476578. Registered on June 11, 2015.
Appendix
Available only for authorised users
Footnotes
1
Since one subgroup (E) included 41 participants, a difference of 2.5% (20:21) was specifically allowed.
 
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Metadata
Title
The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older
Authors
Nir Tsabar
Yan Press
Johanna Rotman
Bracha Klein
Yonatan Grossman
Maya Vainshtein-Tal
Sophia Eilat-Tsanani
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2018
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-017-2812-0

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