Protocol & Case Report Forms (CRF)
Protocol & Case Report Forms (CRF)
1
KERALA UNIVERSITY OF HEALTH SCIENCES (KUHS)
Department : Kayachikitsa
Address : M.G.Road
Telephone : 9447554165
Email : [email protected]
Designation : Professor
Department : Kayachikitsa
Department : Kayachikitsa
Address : Malappuram
Telephone : 9447541935
Email : [email protected]
Department : Kayachikitsa
Email : [email protected]
Department : Kayachikitsa
Co-Investigator : Dr.Pravith N K
Department : Kayachikitsa
Introduction:
3
A) Background and rationale:
B) Scope:
Modern system of medicine manages Diabetes Mellitus with insulin and oral
hypoglycaemic drugs. Clinical trial and research work shows, herbal remedies for Diabetes
as effective, safe and helpful in slowing down complications. Ayurveda formulations are cost
effective and will be a safe solution for the millions of sufferers.
The two study drugs Nisakathakadi kashaya and kathakakhadiradi kashaya are
widely prescribed by Ayurvedic physicians in reducing blood sugar level, though yet not
documented popularly. Also concept of Tridoshas (Vata, Pitha & Kapha) are considered to
be the backbone of Ayurveda. According to Ayurvedic treatise, treatment varies according
to doshic subtypes. So the present study is aimed at evaluating and comparing the
effectiveness of these drugs as well as to find out in which dosha predominance they are
more suitable.
4
Assessing and comparing the hypoglycemic effect of Nisakathakadi Kashaya and
Kathakakhadiradi Kashaya in Type II DM.
Improving the quality of life in patients of Type II DM.
Goals
OBJECTIVES
Plan of study
Group allocation:-
A total of Three hundred patients( thirty patients in each group from each
hospital) satisfying the eligibility criteria will be selected from the OPD of Ayurveda
College Hospitals at Thiruvananthapuram, Trippunithura, Kannur, Ollur and Kottakkal.
Administration of Study drugs will be as follows:
Drug Intervention
Dose of Kashaya : 60ml( 15ml prepared kashaya + 45ml luke warm water) in
both groups.
4. Lactating mother
5. Psychiatric patient
Fasting blood sugar rises to >180 mg. /dl. or post prandial blood sugar level increases to
>240 mg./dl and are not controllable within 30 days.
Any serious complication develops which requires urgent treatment with any other
drug/therapy.
The investigator will mention the probable cause of withdrawal and provide possible
medical treatment to manage the illness.
SAMPLING
a) Sample Size – Total sample size is 300. 60 samples in each five centres with 30 in
group I and 30 in group II.
b) Method of selection – Diabetic patients attending the setting is primarily screened for
satisfying Inclusion and Exclusion criteria. From those, who are ready to give informed
consent, participants will be allocated for each group consecutively till sample size is
achieved.
STUDY VARIABLES
7
3. Hb A1c
4. Scale to assess of Quality of life in DM which is authentic and suitable to the population.
1. Laboratory investigations
2. Questionnaire method
3. Personnel interview
RESEARCH TOOLS
STATISTICAL ANALYSIS
The data collected will be entered into MS Excel Master sheet. Questionnaire
and HRQOL will be assessed by Chi Square test. t – test and ANOVA will be used to test the
efficacy of study drugs using ‘R’ software.
Resources available
8
Consecutively allotted into group I and II
Vth assessment (121st day) using Case report form- III and QOLID
9
Sl.No Investigation Cost No. of tests needed for Total Expenditure
one participant
1 Blood Routine 35 2 70
4 Total Cholesterol 40 2 80
5 Total Bilirubin 30 2 60
7 S.Creatinine 20 3 60
8 Urine Routine 20 3 60
5 Miscellaneous 5000
3. COST OF MEDICINES:
ETHICAL CONSIDERATION:
A. The drugs used in this study are mentioned in the classical text books of Ayurveda and
are having no known side effects in long term use. These two medicines are widely used
among Government and private Ayurvedic Hospitals in Kerala.
B. Ethical Committee (IEC): The proposal will be placed before Ethical Committee (IEC) of
trial center for getting clearance certificate before the project is initiated. Patient’s
information sheet and informed consent form will be submitted along with project
proposal for approval by EC. Both will be maintained in duplicate with one copy given to
the patient at the time of entry to the trial.
References:
11
1. Leonor Guariguata, Tim Nolan, Jessica Beagley, Ute Linnenkamp, Olivier Jacqmain.
(Editors.), IDF Diabetes Atlas 6th Ed, International Diabetes Federation Annual Report 2013,
The Global Burden, Chapter 2, Page 33.
3. Raman Kutty V, Joseph A, Soman CR. High prevalence of type 2 diabetes in an urban
settlement in Kerala, India. Ethn Health 1999; 4 : 231-9.
4. Menon VU, Kumar KV, Gilchrist A, Sugathan TN, Sundaram KR, Nair V, et al. Prevalence
of known and undetected diabetes and associated risk factors in central Kerala - ADEPS.
Diabetes Res Clin Pract 2006; 74 : 289-94.
5. Lakshmi Chandra Mishra et al(2004), Scientific Basis for Ayurvedic Therapies, CRC Press,
Boca Raton London New York Washington, D.C. page no.108-121
12
COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND KATHAKAKHADIRADI
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS –
A PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
CONSENT FORM
CERTIFICATE BY INVESTIGATOR
I certify that I have disclosed all details about the study in the terms easily understood
by the patient.
Name____________________
CONSENT BY SUBJECT
I have been informed to my satisfaction, by the attending physician, the purpose of the
clinical trial and the nature of drug treatment and follow-up, including the laboratory
investigations to be performed to monitor and safeguard my body functions.
I am also aware of my right to opt out of the trial at any time during the course of the
trial without having to give the reasons for doing so.
Relationship ____________
13
KERALA UNIVERSITY OF HEALTH SCIENCES (KUHS)
COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND KATHAKAKHADIRADI
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS –
A PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
Total 60 patients from this hospital and 240 patients from other hospitals will be taking
part in this study.
What will you have to do? -Your doctor will explain clearly what you have to do. It is
important that you follow the instructions scrupulously. The study will take approximately four
months to complete. During this period, you are expected to visit the hospital every fortnight.
The interval between the first and second visit will be around 15 days. Before you start
treatment, during the first visit to the clinic, you will undergo a complete physical examination.
Blood and urine samples will also be taken. This is to make sure that you are eligible for the
study.
One week later, at your second visit, if you are eligible, you would be put on trial
treatment for 120 days. You may receive trial drug for 120 days and will be advised to collect
them every 2 weeks. You should follow life style modifications (Diets Advice & Exercise) as
given along with information Sheet.
At the end of every 30 days, you will be required to fast overnight before attending the
O.P. and Blood and urine samples will be taken. At each visit, you will be supplied with sufficient
quantity of drug to last until your next visit. After 120 days the trial drug will be stopped.
What happens at the end of the study? - After the study you will be put back on an
appropriate treatment available in the market.
Are there any risks? - Trial drug may cause hypoglycemia (very low blood sugar) in some
cases. The symptoms of hypoglycemia are sweating, drowsiness, nausea, confusion and in-
coordination. In case of such symptoms, you should immediately take sugar or glucose/biscuits
and report to the doctor.
What are the alternatives? - Your doctor will be pleased to explain to you the available
alternative treatment to control your blood sugar.
14
When you leave can the study? - Your participation in the study is entirely voluntary. You can
choose to leave the study at any time. Your decision to leave the study will not affect your
medical care or relationship with your doctor. Your doctor may decided that you should
not continue in the study if, a) your blood sugar becomes very high or very low, b) you start on
insulin or other medication that affect blood sugar, c) you take part in any other trial.
What is the cost of the study? - All medication and tests to be done during the study will be
free of charge. If you do not want to participate, you are free to do so. It will not affect your
medical care or relationship with your doctor in any way.
What happens now if you decided to take part? - You will asked to sign a consent form saying
that you have been given information about the study and you voluntarily agree to take part.
It is important to follow all instruction given by your doctor or doctor’s assistant carefully.
DIET REGIMEN:
DO’NTs - To avoid smoking. To avoid Fasting. To avoid sweets, honey, sugar, Jiggery, cold drinks, fruit
juice, Potato, Tapioca& Beetroot. Avoid more sweet fruits like Mango, Grapes, Chiku, Banana, Dates etc.
15
COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND KATHAKAKHADIRADI
KASHAYAM’ IN TYPE II DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS – A
PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
2. Centre: _____________
7. Address: ______________________________________________________
If answers for Q.No. 8 and 9 are ‘Yes’ and 10 to 18 are ‘No’ then the participant is eligible for
the study.
17
COMPARATIVE EFFECTIVENESS OF ‘NISAKATHAKADI KASHAYAM AND KATHAKAKHADIRADI
KASHAYAM’ IN TYPE 2 DIABETES MELLITUS USING BIOCHEMICAL AND HRQOL PARAMETERS – A
PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY
2. Centre: _____________
3. Name of the subject: ___________________________________
4. S.No. of the subject: ___________________________________
7. Address: ___________________________________________________________
___________________________________________________________
School Certificate 4
B. Occupation Score:
worker 2 Unemployed 1
16019 6
18
8010 – 12019 4 4810 – 8009 3 1601 – 4809 2
1600 or less 1
Christian Parsi
11. Whether under any Oral Hypoglycemic agents? Yes No
If Yes, specify ____________________________________
Sannipataja
16. Exhaustion/Tiredness
19
17. Loss of body weight
19. Giddiness
22. Others
Personal History:
Addiction
If yes specify: (a) Quantity [packs]: _________ (b) Total Duration in year’s_________
20
Physical Examination
Systolic_________________(mm Hg)
37. CVS
If abnormal, details _______________________________________________
_______________________________________________
38. CNS
If abnormal, details ______________________________________________
______________________________________________
21
______________________________________________
2. Centre: _____________
22
Before 31st day 61st day 91stday 120st day
Treatment
1. Cold hands 0 0 0 0 0
and/or feet 1 1 1 1 1
(Kapha) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
2. An overall sense 0 0 0 0 0
of fatigue 1 1 1 1 1
(Kapha) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
3.Burning 0 0 0 0 0
sensation on 1 1 1 1 1
hands/feet 2 2 2 2 2
(Pitha) 3 3 3 3 3
4 4 4 4 4
4. Sleepiness or 0 0 0 0 0
drowsiness (during 1 1 1 1 1
the day) 2 2 2 2 2
(Kapha) 3 3 3 3 3
4 4 4 4 4
0 0 0 0 0
5. Blurred vision 1 1 1 1 1
(also with glasses 2 2 2 2 2
on) (Pitha) 3 3 3 3 3
4 4 4 4 4
6. Dry mouth 0 0 0 0 0
(Vata) 1 1 1 1 1
2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
7. Felt unusually 0 0 0 0 0
thirsty 1 1 1 1 1
(Pitha) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
23
8. Felt unusually 0 0 0 0 0
hungry 1 1 1 1 1
(Pitha) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
9. Frequent need 0 0 0 0 0
to urinate (Vata) 1 1 1 1 1
2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
10. Tingling or 0 0 0 0 0
prickling 1 1 1 1 1
sensations in 2 2 2 2 2
hands or feet 3 3 3 3 3
(Vata) 4 4 4 4 4
11. Cramping in 0 0 0 0 0
legs or feet 1 1 1 1 1
(Vata) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
0 0 0 0 0
12. Irritability
1 1 1 1 1
(Vata)
2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
24
or light headed. 1 1 1 1 1
(Vata) 2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
16. Upset
stomach/nausea 0 0 0 0 0
(Kapha) 1 1 1 1 1
2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
17. Heart burn
0 0 0 0 0
(Pitha)
1 1 1 1 1
2 2 2 2 2
3 3 3 3 3
4 4 4 4 4
Total Score
Total Score
Vata Pitha Kapha
B. Laboratory investigations
Blood:-
Haemoglobin (gm/dl)
Total count
(Cells/Cmm)
Polymorphs(%)
Lymphocytes
25
Eosinophills
Monocytes
Lymphocytes
HbA1c
Total Cholesterol
(mg/dl)
Total Bilirubin(mg/dl)
S.Creatinine(mg/dl)
F.B.S(mg/dl)
P.P.B.S(mg/dl)
Urine:-
Sugar
Albumin
Deposits
RBC(hpf)
Cast(hpf)
C. Physiological Assessment:
Blood Pressure
(sitting) mm/Hg
26
Weight in Kgs
B.M.I
27
6. Compared to others of your age are your social activities (visiting friends/partying) limited
because of your diabetes?
Always Frequently Often Sometimes Never
1 2 3 4 5
Physical Endurance
An important part of understanding your general health and well being has to do with your
ability to perform various activities.Thus for the following questions please indicate if your
health has limited your activities in following areas in the past three months. Please tick any
one option.
1. How often in last three months has your overall health problems limited the kind of vigorous
activities you can do like lifting heavy bags/objects, running, skipping, jumping.
Always Frequently Often Sometimes Never
1 2 3 4 5
2. How often in last three months has your overall health problems limited the kind of
moderate activities you can do like moving a table, carrying groceries or utensils.
Always Frequently Often Sometimes Never
1 2 3 4 5
3. How often in last three months has your overall health problems limited you from walking
uphill or climbing 1-2 floors.
Always Frequently Often Sometimes Never
1 2 3 4 5
4. How often in last three months has your overall health problems limited you from walking 1-
2 km at a stretch.
Always Frequently Often Sometimes Never
1 2 3 4 5
5. How often in last three months has your overall health problems limited you from bending,
squatting, or turning.
Always Frequently Often Sometimes Never
1 2 3 4 5
6. How often in last three months has your overall health problems limited you from eating,
dressing, bathing, or using the toilet.
Always Frequently Often Sometimes Never
1 2 3 4 5
General Health
1. In general would you say your health is.
Poor Fair Good Very good Excellent
1 2 3 4 5
28
2. How well are you able to concentrate in everything like working, driving, reading etc?
Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
3. How many times in the past three months have you had fatigue/ felt very tired?
Always Frequently Often Sometimes Never
1 2 3 4 5
Treatment Satisfaction
The following set of questions would enable us to know how satisfied are you with your
treatment for diabetes. Please tick any one option.
1. How satisfied are you with your current diabetes treatment?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
2. How satisfied are you with amount of time it takes to manage your diabetes?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
3. How satisfied are you with the amount of time you spend getting regular checkups (once in 3
months)?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
4. A person with diabetes needs to exercise for 35-45 min, 4 times a week. Keeping this in mind
how satisfied are you with the time you spend exercising?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
Symptom Botherness
1. How many times in the past three months have you had thirst/dry mouth?
29
Always Frequently Often Sometimes Never
1 2 3 4 5
2. How many times in the past three months have you felt excessive hunger?
Always Frequently Often Sometimes Never
1 2 3 4 5
3. How many times in the past three months have you had frequent urination related to
diabetes management?
Always Frequently Often Sometimes Never
1 2 3 4 5
Financial Worries
The following set of questions will help us know how your diabetes has affected your or your
family’s finances. Please tick any one option….
1. What do you think about the cost involved in your management of diabetes?
Very expensive little expensive reasonable not at all Expensive
1 2 3 4 5
2. To what extent has your priority of expenditure shifted towards diabetes management?
A lot Highly Little Very little Not at all
1 2 3 4 5
3. To what extent has your family budget got affected by the expenses related to the
management of diabetes?
A lot Highly Little Very little Not at all
1 2 3 4 5
4. To what extent has your diabetes limited your expenditure on other aspects of life (Movies,
outings, parties etc)?
A lot Highly Little Very little Not at all
1 2 3 4 5
Emotional/Mental Health
1. How satisfied are you with yourself?
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
2. How satisfied are you with your personal relationship(family, friends,relatives and known tos)
30
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
3. How satisfied are you with the emotional support you get from your friends and family?
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
4. How often are you discouraged by your health problems?
Always Frequently Often Sometimes Never
1 2 3 4 5
5. All people want to fulfill certain roles and lead their lives in a purposeful manner. To what
extent do you feel that you have been able to lead your life in the same way?
Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
Diet Satisfaction
Diabetes demands a little modification in diet, thus the following set of questions would help us
know how much satisfied you are with modifications in your diet.(For participants who have
been advised some dietary modification/counseling).
1. How often do you feel because of your diabetes a restriction in choosing your food when
eating out?
Always Frequently Often Sometimes Never
1 2 3 4 5
2. As you have diabetes, how much choice do you feel you have in eating your meals or snacks
away from home e.g. if you go in a party and there is a buffet where there are also a lot of fried
snacks and desserts would you be able to make enough choice?
No choice Very little little enough A lot
1 2 3 4 5
3. How often do you eat the food items that you shouldn’t, in order to hide the fact that you are
having diabetes.
Always Frequently Often Sometimes Never
1 2 3 4 5
QOLID Score:
SCALE NUMBER OF ITEMS AVERAGE OF THE ITEMS
Role Limitation Due to Physical 6
Health
31
Physical Endurance 6
General Health 3
Treatment Satisfaction 4
Symptom Botherness 3
Financial Worries 4
Emotional/Mental Health 5
Diet Satisfaction 3
32
Always Frequently Often Sometimes Never
1 2 3 4 5
Physical Endurance
An important part of understanding your general health and well being has to do with your
ability to perform various activities.Thus for the following questions please indicate if your
health has limited your activities in following areas in the past three months. Please tick any
one option.
1. How often in last three months has your overall health problems limited the kind of vigorous
activities you can do like lifting heavy bags/objects, running, skipping, jumping.
Always Frequently Often Sometimes Never
1 2 3 4 5
2. How often in last three months has your overall health problems limited the kind of
moderate activities you can do like moving a table, carrying groceries or utensils.
Always Frequently Often Sometimes Never
1 2 3 4 5
3. How often in last three months has your overall health problems limited you from walking
uphill or climbing 1-2 floors.
Always Frequently Often Sometimes Never
1 2 3 4 5
4. How often in last three months has your overall health problems limited you from walking 1-
2 km at a stretch.
Always Frequently Often Sometimes Never
1 2 3 4 5
5. How often in last three months has your overall health problems limited you from bending,
squatting, or turning.
Always Frequently Often Sometimes Never
1 2 3 4 5
6. How often in last three months has your overall health problems limited you from eating,
dressing, bathing, or using the toilet.
Always Frequently Often Sometimes Never
1 2 3 4 5
General Health
1. In general would you say your health is.
Poor Fair Good Very good Excellent
1 2 3 4 5
33
2. How well are you able to concentrate in everything like working, driving, reading etc?
Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
3. How many times in the past three months have you had fatigue/ felt very tired?
Always Frequently Often Sometimes Never
1 2 3 4 5
Treatment Satisfaction
The following set of questions would enable us to know how satisfied are you with your
treatment for diabetes. Please tick any one option.
1. How satisfied are you with your current diabetes treatment?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
2. How satisfied are you with amount of time it takes to manage your diabetes?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
3. How satisfied are you with the amount of time you spend getting regular checkups (once in 3
months)?
Very Moderately Neither Moderately Very
dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
4. A person with diabetes needs to exercise for 35-45 min, 4 times a week. Keeping this in mind
how satisfied are you with the time you spend exercising?
Very Moderately Neither Moderately Very
Dissatisfied dissatisfied satisfied nor dissatisfied Satisfied satisfied
1 2 3 4 5
Symptom Botherness
1. How many times in the past three months have you had thirst/dry mouth?
Always Frequently Often Sometimes Never
34
1 2 3 4 5
2. How many times in the past three months have you felt excessive hunger?
Always Frequently Often Sometimes Never
1 2 3 4 5
3. How many times in the past three months have you had frequent urination related to
diabetes management?
Always Frequently Often Sometimes Never
1 2 3 4 5
Financial Worries
The following set of questions will help us know how your diabetes has affected your or your
family’s finances. Please tick any one option….
1. What do you think about the cost involved in your management of diabetes?
Very expensive little expensive reasonable not at all Expensive
1 2 3 4 5
2. To what extent has your priority of expenditure shifted towards diabetes management?
A lot Highly Little Very little Not at all
1 2 3 4 5
3. To what extent has your family budget got affected by the expenses related to the
management of diabetes?
A lot Highly Little Very little Not at all
1 2 3 4 5
4. To what extent has your diabetes limited your expenditure on other aspects of life (Movies,
outings, parties etc)?
A lot Highly Little Very little Not at all
1 2 3 4 5
Emotional/Mental Health
1. How satisfied are you with yourself?
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
2. How satisfied are you with your personal relationship(family, friends,relatives and known tos)
35
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
3. How satisfied are you with the emotional support you get from your friends and family?
Very Moderately Neither Moderatel Very
y
dissatisfied dissatisfied satisfied nor dissatisfied satisfied
Satisfied
1 2 3 4 5
4. How often are you discouraged by your health problems?
Always Frequently Often Sometimes Never
1 2 3 4 5
5. All people want to fulfill certain roles and lead their lives in a purposeful manner. To what
extent do you feel that you have been able to lead your life in the same way?
Not at all A little Moderate Very much An extreme amount
1 2 3 4 5
Diet Satisfaction
Diabetes demands a little modification in diet, thus the following set of questions would help us
know how much satisfied you are with modifications in your diet.(For participants who have
been advised some dietary modification/counseling).
1. How often do you feel because of your diabetes a restriction in choosing your food when
eating out?
Always Frequently Often Sometimes Never
1 2 3 4 5
2. As you have diabetes, how much choice do you feel you have in eating your meals or snacks
away from home e.g. if you go in a party and there is a buffet where there are also a lot of fried
snacks and desserts would you be able to make enough choice?
No choice Very little little enough A lot
1 2 3 4 5
3. How often do you eat the food items that you shouldn’t, in order to hide the fact that you are
having diabetes.
Always Frequently Often Sometimes Never
1 2 3 4 5
QOLID Score:
SCALE NUMBER OF ITEMS AVERAGE OF THE ITEMS
Role Limitation Due to Physical 6
Health
36
Physical Endurance 6
General Health 3
Treatment Satisfaction 4
Symptom Botherness 3
Financial Worries 4
Emotional/Mental Health 5
Diet Satisfaction 3
37