NCT02476578

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

July 29, 2019

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

June 11, 2015

Results QC Date

March 10, 2018

Last Update Submit

March 28, 2020

Conditions

Weight LossThinnessMalnutrition

Keywords

HypocholesterolemiaFrail ElderlyAgedAged, 80 and overCholesterolClinical Laboratory Information SystemsHemoglobin A, Glycosylateddiet therapyAnticholesteremic AgentsHealth Services for the AgedHypoglycemic AgentsHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Death From Any Cause

    Impact on overall-survival

    1 year

Secondary Outcomes (3)

  • Impact on Evaluation Rate

    1 year

  • Impact on Medical Costs

    1 year

  • Impact on a Composite Measure of Medical Treatment

    1 year

Study Arms (2)

Intervention Email

EXPERIMENTAL

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

Control

NO INTERVENTION

No email is sent.

Interventions

EmailOTHER

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

Also known as: "Dry Counseling"
Intervention Email

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • All found by computerized search in the data base of Clalit Health Services North and South districts:
  • \. 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
  • \. Last HbA1c% level of 6.5% or less AND
  • dispensing anti-diabetic medicines during previous 2 months
  • \. Last total cholesterol less than 160 mg/dL AND
  • dispensing cholesterol-lowering medicines during previous 2 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Flegal KM, Kit BK, Orpana H, Graubard BI. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis. JAMA. 2013 Jan 2;309(1):71-82. doi: 10.1001/jama.2012.113905.

    PMID: 23280227BACKGROUND

  • Giovannelli J, Coevoet V, Vasseur C, Gheysens A, Basse B, Houyengah F. How can screening for malnutrition among hospitalized patients be improved? An automatic e-mail alert system when admitting previously malnourished patients. Clin Nutr. 2015 Oct;34(5):868-73. doi: 10.1016/j.clnu.2014.09.008. Epub 2014 Sep 18.

    PMID: 25277380BACKGROUND

  • Iribarren C, Reed DM, Chen R, Yano K, Dwyer JH. Low serum cholesterol and mortality. Which is the cause and which is the effect? Circulation. 1995 Nov 1;92(9):2396-403. doi: 10.1161/01.cir.92.9.2396.

    PMID: 7586337BACKGROUND

  • Currie CJ, Peters JR, Tynan A, Evans M, Heine RJ, Bracco OL, Zagar T, Poole CD. Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study. Lancet. 2010 Feb 6;375(9713):481-9. doi: 10.1016/S0140-6736(09)61969-3. Epub 2010 Jan 26.

    PMID: 20110121BACKGROUND

  • Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Low Glycated Hemoglobin Level in Older Adults: Results of the Low Indexes of Metabolism Intervention Trial B (LIMIT-B). J Am Med Dir Assoc. 2020 Feb;21(2):277-280.e3. doi: 10.1016/j.jamda.2019.08.004. Epub 2019 Oct 3.

    PMID: 31588026RESULT

  • Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. A Randomized Trial of Alerting to Hypocholesterolemia Results of the Low Indexes of Metabolism Intervention Trial-C (LIMIT-C). J Am Med Dir Assoc. 2020 Mar;21(3):410-414. doi: 10.1016/j.jamda.2019.08.018. Epub 2019 Oct 12.

    PMID: 31610995RESULT

  • Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. Randomized trial results of alerting primary clinicians to severe weight loss among older adults in the Low Indexes of Metabolism Intervention Trial part A. Geriatr Gerontol Int. 2020 Apr;20(4):329-335. doi: 10.1111/ggi.13888. Epub 2020 Feb 16.

    PMID: 32064727RESULT

  • Tsabar N, Press Y, Rotman J, Klein B, Grossman Y, Vainshtein-Tal M, Eilat-Tsanani S. 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. BMC Health Serv Res. 2018 Jan 5;18(1):4. doi: 10.1186/s12913-017-2812-0.

    PMID: 29301522DERIVED

Related Links

MeSH Terms

Conditions

Weight LossThinnessMalnutritionHypoglycemia

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesGlucose Metabolism DisordersMetabolic Diseases

Results Point of Contact

Title
Dr. Nir Tsabar
Organization
CLALIT HEALTH SERVICES
NIR.TSABAR@CLALIT.ORG.IL
+97246049512

Study Officials

  • Nir Tsabar, MD/PhD

    ClalitHS North District Principal Geriatrist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
North District Principal Geriatrician

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 19, 2015

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 9, 2020

Results First Posted

July 29, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request to email nir.tsabar@clalit.org.il. Shared data will not include exact dates, exact lab results or any data that might expose the identity of patients. Also, commercial data such as drug brands or costs may not be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publishing the results in a peer reviewed journal.
Access Criteria
Any clinical researcher; Any ethically approved clinical research

Available IPD Datasets

Study Protocol Access