Weight Loss Clinical Trial
— LIMITOfficial title:
Sending Advisory Electronic Mail to Primary Care Staff, Addressing Low Metabolic Measures: Assessing the Health Outcomes for Patients Above Age 75
Verified date | March 2020 |
Source | Clalit Health Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8584 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Clalit Health Services |
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 Ass — View Citation
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 Geron — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death From Any Cause | Impact on overall-survival | 1 year | |
Secondary | Impact on Evaluation Rate | Percentage of patients evaluated by a nurse and counseled by a dietitian | 1 year | |
Secondary | Impact on Medical Costs | Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines. | 1 year | |
Secondary | Impact on a Composite Measure of Medical Treatment | A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email. | 1 year |
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