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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

BMC Health Services Research 1/2018

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

Zeitschrift:
BMC Health Services Research > Ausgabe 1/2018
Autoren:
Nir Tsabar, Yan Press, Johanna Rotman, Bracha Klein, Yonatan Grossman, Maya Vainshtein-Tal, Sophia Eilat-Tsanani
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12913-017-2812-0) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: English translation of LIMIT’s protocol. (DOCX 48 kb)
12913_2017_2812_MOESM1_ESM.docx
Additional file 2: LIMIT’s - Flow Diagram. (DOCX 30 kb)
12913_2017_2812_MOESM2_ESM.docx
Literatur
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