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Transcript
Utilizing Science & Technology and Innovation
for Development
Impact of SMS on improving
Medication Adherence among
Diabetes Mellitus Type-2 in
Jordan
Marriott Hotel- Amman, August 13th, 2015
Project Team
 Fadi M. Alkhateeb, BSPharm, MBA, Ph.D.
Director of Assessment & Associate Professor of Pharmacy
Texas A&M Health Science Center College of Pharmacy
Texas, USA
 Lara Tutunji, BSPharm, Ph.D.
Assistant Professor of Pharmacy
The University of Jordan College of Pharmacy
Amman, Jordan
Brief Description
•
•
•
•
•
Poor adherence to treatment of chronic disease is worldwide problem of
striking magnitude. Recently, the world health organization stated that
only 50% of patient diagnosed with chronic illness were fully compliant
with their treatment regimen, in developing country the rate are even
lower.1
It is undeniable that many patient experiences difficulty in following
treatment recommendations
Several studies suggest that a large proportion of people with diabetes
have difficulty managing their medication regimens (oral hypoglycemic
agents [OHAs] and insulin) as well as other aspects of self-management 1
Worldwide, adherence rate for medication for diabetes vary between 36
and 93%2
Adherence to prescribed medication is crucial to reach metabolic
control as non adherence with blood glucose lowering drug is associated
with higher HbAIc levels
Brief Description
• Poor medication adherence (i.e., failure to take the proper medication at the
correct time) is a causative factor for diminished control of type 2 diabetes
mellitus (T2DM) in patients.
• Poor adherence is also correlated with an increased incidence of vascular,
nephrologic, neurologic and ophthalmological complications as well as a
higher cost burden1.
• One of the chief causes for suboptimal adherence is patients’ inability to
recall and act upon dosage regimens2.
• Other variables associated with a lack of compliance in T2DM include
socioeconomic status, and low health literacy 3,4.
• Low health literacy is also significantly associated with hypoglycemic
episodes 5.
Justifications
• Due to the high penetration of mobile phones
across socioeconomic groups and the high read rate
for mobile SMS (short message service), text
message medication reminders offer a promising
intervention for improving medication adherence in
T2DM patients.
Objectives
• The primary objective of this study is to improve
medication adherence in patients with T2DM via use of
daily SMS medication reminders.
• Secondary objectives include:
1) to assess health literacy levels in an ethnically
diverse, patient population,
2) to examine the predictive potential of measured
health literacy and disease knowledge for
medication adherence, and
3) to perform a test-retest with health literacy and
disease knowledge assessment tools.
Scope of work/Duration
Estimated Budget
Scope of work:
Health & Environment /
Pharmaceutical Outcomes
Duration: One year
Estimated Budget: 42,500 JOD ($70,000)
Research Team
• Nurse as research assistant to fill out the
questionnaires, collect baseline data, and
make sure that SMS messages are being sent
• Internist for evaluation of results compared to
baseline data
• Statistician for statistical evaluation of results
Methodology of Implementation
 A randomized, open-label, controlled study will be conducted at the Health Center /
Nazzal, Amman, Jordan with a diverse patient population.
 The intervention is daily SMS medication reminders. Participants will be randomized to
either the SMS + standard care group (intervention) or standard care alone (control)
group for 6 months.
 Baseline data, including HbA1C, demographics, and medication regimens will be
collected for all patients at the initial visit. Other measures employed at baseline and
month 6 in this study include health literacy via the REALM-SF (Rapid Estimate of
Adult Literacy in Medicine – Short Form) instrument and disease knowledge with the
DKT (Disease Knowledge Test) – T2DM subset tool to allow for test-retest validation.
 Medication adherence will be assessed at months 3 and 6 via refill records, the MMAS
(Morisky Medication Adherence Scale) and measured by hemoglobin A1C (HbA1C).
Methodology of Implementation
 Baseline data, including HbA1C, demographics, and medication regimens
will be collected for all patients at the initial visit.
 Those patients randomized to the SMS group will receive daily text
messages which will be administered by use of the SMS by research
personnel. The daily text message will be delivered to participants cell
phones to read, “It’s that time”.
 Data collected at subsequent patient visits at months 3 and 6 will include
patient counseling, HbA1c, and all standard labs along with assessment of
adherence (MMAS) in both groups.
 In the intervention group only, a brief, 3-item questionnaire will be
administered to assess satisfaction and to evaluate SMS alert fatigue at
months 3 and 6
Methodology of Implementation
 For both groups, disease state knowledge and health literacy assessments
will be administered again at month 6 in order to allow for test-retest
validation. The data will be evaluated using logistic regression analysis
 A sample size of 300 patients was calculated to be sufficient to provide a
power of 80% to detect a 10% (absolute value 0.75%, estimated SD 1.0)
change in HbA1c at the 5% level of significance, assuming a dropout rate of
10%.
 Baseline data, including HbA1C, demographics, and medication regimens
will be collected for all patients at the initial visit and the REALM-SF and
DKT-T2DM will similarly be administered in both arms at that time.
 Inferential statistical tests will be used to assess the effect of SMS on
adherence.
 Multivariable linear regression will be used to explore associations between
health literacy and HbA1C levels
Summary
Baseline
3 Month
6 Month
HbA1C
HbA1C
HbA1C
MMAS
MMAS
Refills records
Refills records
REALM-SF
REALM-SF
DKT
DKT
demographics &
Satisfaction Survey* Satisfaction Survey*
medication regimens
*: Only Intervention
Methodology of Implementation
Patient Population
• The patients will be randomly selected from the Outpatient Clinics of
healthcare centre in Nazal area, Amman, Jordan. Patients’ consent should
be obtained according to the regulations of the Ministry of Health in
Jordan.
• Clinicians at the Health Center / Nazzal, Amman, Jordan will screen,
recruit and determine eligibility for adult patients who are newly diagnosed
with type 2 diabetes mellitus (T2DM),
• Inclusion criteria for all participants will include:
o Patients  18 years of age, who have been newly diagnosed with T2DM at least
1 year earlier,
o Who received oral hypoglycemic medication (sulphonylurea or/and biguanide),
o Who did not use insulin or suffer from chronic complications,
o have SMS-capable cell phones, and who are Arabic literate.
Expected output
•
Our study will show an evidence on the
effectiveness of SMS interventions to enhance
adherence in patients suffering type 2 diabetes
mellitus.
•
The outcomes of this study indicates that SMS
could have an influential and important role in
improving adherence in patients taking type 2
diabetes mellitus medications
Impact
If significant improvement is detected in the intervention
group, it could be the basis for a large, multi-center study to
be used as guidance for a low cost, high impact method to
increase medication adherence, improve patient outcomes,
and help address the $1.0 billion cost burden of the this
public health issue in Jordan.
Action Plan
Funding
• Estimated Budget: 42,500 JOD ($70,000)
• Salaries for a physician and a nurse.
• Reimbursement for 300 patients for their time (20JD)
• Cost for sending SMS messages (3*180*150)
• Statistician for statistical evaluation of results (1000JD)
• Texas A&M University Division of Research Program to
Enhance Scholarly and Creative Activities (PESCA) Grant,
($25,000) and will be applying to the
• Scientific Research Fund (SRF) ($45.000).
References
1. Vermeire E, Wens J, Van Royen P, Biot Y, Hearnshaw H, Lindenmeyer A. Interventions for
improving adherence to treatment recommendations in people with type 2 diabetes mellitus.
Cochrane Database Syst Rev. 2005;(2):CD003638.
2. Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature.
Diabetes Educ. 2007;33(6):1014-29; 1030-1.
3. Cabellero AE, Tenzer P. Building cultural competency for improved diabetes care: Latino
Americans and diabetes. J Fam Pract. 2007;56(9 Suppl Building):S7-13.
4. Schillinger D, Grumbach K, Piette J, Wang F, Osmond D, Daher C, Palacios J, Sullivan GD,
Bindman AB. Association of health literacy with diabetes outcomes. JAMA. 2002;288(4):475-82.
5. Sarkar U, Karter AJ, Liu JY, Moffet HH, Adler NE, Schillinger D. Hypoglycemia is More
Common Among Type 2 Diabetes Patients with Limited Health Literacy: The Diabetes Study of
Northern California (DISTANCE). J Gen Intern Med. 2010;25(9):962-8.
6. Brunton S. Implementing treatment guidelines for type 2 diabetes in primary care. Postgrad
Med. 2009;121(2):125-38.
7. Ajlouni K1, Khader YS, Batieha A, Ajlouni H, El-Khateeb M. An increase in prevalence of
diabetes mellitus in Jordan over 10 years. J Diabetes Complications. 2008 Sep-Oct;22(5):317-24.
Appendix A. Rapid Estimate of Adult Learning in
Medicine – Short Form (REALM-SF)
Patient name --------- Date of birth-------- Reading level
Examiner ------- Grade completed ---------Word
Menopause
Antibiotics
Exercise
Jaundice
Rectal
Anemia
Behavior
Date ----------------
☐
☐
☐
☐
☐
☐
☐
Instructions for Administering the REALM-SF
1.Give the patient a laminated copy of the REALM-SF form and score answers on an unlaminated copy that is attached to a clipboard. Hold the
clipboard at an angle so that the patient is not distracted by your scoring. Say:
"I want to hear you read as many words as you can from this list. Begin with the first word and read aloud. When you come to a word you cannot read,
do the best you can or say, 'blank' and go onto the next word."
2.If the patient takes more than five seconds on a word, say "blank" and point to the next word, if necessary, to move the patient along. If the patient
begins to miss every word, have him or her pronounce only known words
Permissions: REALM-SF was developed by researchers via a the Agency for Healthcare Research and
Quality (AHRQ), a publicly funded agency which is not copyrighted. Per AHRQ, “These tools can be used
for research, clinical, or program planning purposes“ (http://www.ahrq.gov/populations/sahlsatool.htm)
Appendix B. Diabetes Knowledge Test (DKT) –
T2DM subset of questions
1. The diabetes diet is:
a. the way most American people eat
b. a healthy diet for most people
c. too high in carbohydrate for most people
d. too high in protein for most people
2. Which of the following is highest in carbohydrate?
a. Baked chicken
b. Swiss cheese
c. Baked potato
d. Peanut butter
3. Which of the following is highest in fat?
a. Low fat milk
b. Orange juice
c. Corn
d. Honey
Appendix C. Morisky Medication Adherence
Scale (MMAS)




Do you ever forget to take your medicine? (Yes/No)
Are you careless at times about taking your medicine?
(Yes/No)
When you feel better do you sometimes stop taking your
medicine? (Yes/No)
Sometimes if you feel worse when you take the medicine, do
you stop taking it? (Yes/No)
Permissions: MMAS permission granted directly from copyright
holder, Dr. Donald Morisky.