Low Indexes of Metabolism - Information to Teams (LIMIT) (LIMIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02476578|
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : December 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Thinness Malnutrition||Other: Email||Not Applicable|
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.
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.
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- Death from any cause [ Time Frame: 1 year ]Impact on overall-survival
- Impact on evaluation rate [ Time Frame: 1 year ]Percentage of patients evaluated by a nurse and counseled by a dietician
- Impact on medical costs [ Time Frame: 1 year ]Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
- 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.
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
|Principal Investigator:||Nir Tsabar, MD/PhD||ClalitHS North District Principal Geriatrist|