An interventional study of Email in Weight Loss, Thinness and Malnutrition, sponsored by Clalit Health Services. Completed. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by Clalit Health Services · Not applicable, Interventional, and Treatment
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.
Scientific background
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.
Objectives
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.
Working hypotheses
During a year, and relative to the control group, intervention emails may result in the following:
Type of research and methods of data collection
This randomized controlled trial will be conducted entirely through the existing computer system. The participants (patients) will be assigned to the two Arms/Groups "Intervention Email" and "Control". 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. The alerts will be sent to the primary clinicians.
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.
66 studies on the registry are indexed under Thinness; 11 are open to participants now.
This study's enrollment of 8,584 is above the median of 287 across 43 interventional studies indexed under Thinness.
Browse Thinness studies →Clalit Health Services is the lead sponsor of 44 studies on the registry; none are open to participants now.
Compared within Thinness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No email is sent.
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"
Death From Any Cause
Impact on overall-survival
Time frame: 1 year
Impact on Evaluation Rate
Percentage of patients evaluated by a nurse and counseled by a dietitian
Time frame: 1 year
Impact on Medical Costs
Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
Time frame: 1 year
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.
Time frame: 1 year
| Milestone | Intervention Email | Control |
|---|---|---|
| Started | 4310 | 4274 |
| Died before email was sent | 35 | 43 |
| Left before end of trial | 6 | 13 |
| Completed | 4269 | 4218 |
| Not completed | 41 | 56 |
| Withdrew: Died before email was sent (<9.11.2015) | 35 | 43 |
| Withdrew: Lost to follow-up | 6 | 13 |
Impact on overall-survival
| Participants | Intervention Email | Control |
|---|---|---|
| Death From Any Cause | 285 | 245 |
Percentage of patients evaluated by a nurse and counseled by a dietitian
| Participants | Intervention Email | Control |
|---|---|---|
| Impact on Evaluation Rate | 3387 | 3337 |
Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.
No measurements were reported for this outcome.
A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.
No measurements were reported for this outcome.
Collected over Adverse event data were collected for 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Email | 285/4,269 (6.7%) | 0/4,269 (0%) | 0/4,269 (0%) |
| Control | 245/4,218 (5.8%) | 0/4,218 (0%) | 0/4,218 (0%) |
| Age, Continuous(years) | Intervention Email | Control | Total |
|---|---|---|---|
| Mean | 80.6 ± 4.7 | 80.8 ± 4.9 | 80.7 ± 4.8 |
| Sex: Female, Male(Participants) | Intervention Email | Control | Total |
|---|---|---|---|
| Female | 2484 | 2445 | 4929 |
| Male | 1785 | 1773 | 3558 |
| Race and Ethnicity Not Collected(Participants) | Intervention Email | Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intervention Email | Control | Total |
|---|---|---|---|
| Israel | 4269 | 4218 | 8487 |
| Body Mass Index (BMI)(kg/m^2) | Intervention Email | Control | Total |
|---|---|---|---|
| Mean | 28.7 ± 5.9 | 28.8 ± 5.9 | 28.8 ± 5.9 |
| HbA1c% Mean (Standard Deviation)(%) | Intervention Email | Control | Total |
|---|---|---|---|
| Mean | 6.51 ± 1.05 | 6.46 ± 1.00 | 6.49 ± 1.02 |
| Total Cholesterol Mean (Standard Deviation)(mg/dL) | Intervention Email | Control | Total |
|---|---|---|---|
| Mean | 154.61 ± 33.88 | 154.23 ± 33.60 | 154.42 ± 33.74 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: After publishing the results in a peer reviewed journal.
Access criteria: Any clinical researcher; Any ethically approved clinical research
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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