The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Case Report Form
TWELVE MONTH
FOLLOW UP
ASSESSMENT
Page 1 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
1. Twelve Month Follow Up
Patient identification number
Date of twelve month follow up
D
D
M
M
Y
Y
Y
Y
GP Practice (Site) Number
Researcher Initials
Signature of Assessor
Clinical Measures: Blood Pressure
Systolic blood pressure
mmHg
Date recorded:
D
D
M
M
Y
Y
Y
Diastolic blood pressure
Y
mmHg
Date recorded:
D
D
M
M
Y
Y
Y
Y
Clinical Measures: Anthropometric Measures
Weight
Date recorded
.
D
Body Mass Index
kilograms
D
M
.
D
D
Y
Y
Y
Y
weight in kgs/(height in metres)2
.
Waist circumference
Date recorded
M
M
centimetres
M
Y
Y
Y
Y
Page 2 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Section 3: Clinical Measures: Blood Tests
Total Cholesterol
Date recorded:
mmol/litre
.
D
D
M
M
Y
HDL Cholesterol
Date recorded:
D
D
M
M
Y
Y
Y
.
D
D
M
M
mmol/litre
Y
Y
Y
Y
mmol/litre
.
D
D
M
M
Triglycerides
Date recorded:
Y
mmol/litre
Y
Total Cholesterol/HDL ratio
Date recorded:
Y
.
LDL Cholesterol
Date recorded:
Y
Y
Y
Y
mmol/litre
.
D
D
M
Y
M
Y
Y
Y
Y
Blood Glucose
HBA1C (value)
Date recorded:
mmol/mol
D
D
M
M
Y
or HBA1C (percentage)
Date recorded:
Y
.
D
D
Fasted blood glucose
Mmol/mol
Date recorded :
M
D
M
Y
D
Random blood glucose
Date recorded:
Y
%
Y
M
Y
M
D
M
M
Y
Y
Y
Y
Y
mmol/l
.
D
Y
Y
Y
Y
Y
Page 3 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Section 4
4.1 Lifestyle Questionnaires: Alcohol Use Disorders Identification Test
(AUDIT)
This is one unit of alcohol…
…and each of these is more than one unit
Alcohol Use Disorders Identification Test: AUDIT – C
Questions
How often do you have a drink
containing alcohol?
How many units of alcohol do you
drink on a typical day when you are
drinking?
How often have you had 6 or more
units if female, or 8 or more if male,
on a single occasion in the last year?
Scoring system
Your
score
0
1
2
3
4
Never
Monthly
or less
2-4
times
per
month
2-3
times
per
week
4+
times
per
week
1 -2
3-4
5-6
7-9
10+
Never
Less
than
monthly
Weekly
Daily
or
almost
daily
Scoring:
A total of 5+ indicates increasing or higher risk drinking.
An overall total score of 5 or above is AUDIT-C positive.
Monthly
SCORE
Page 4 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Score from AUDIT- C (other side)
SCORE
Remaining AUDIT questions
(To be completed if AUDIT-C score is 5 or above)
Questions
How often during the last year have
you found that you were not able to
stop drinking once you had started?
How often during the last year have
you failed to do what was normally
expected from you because of your
drinking?
How often during the last year have
you needed an alcoholic drink in the
morning to get yourself going after a
heavy drinking session?
How often during the last year have
you had a feeling of guilt or remorse
after drinking?
How often during the last year have
you been unable to remember what
happened the night before because
you had been drinking?
Scoring system
0
1
Never
Less
than
monthly
Never
Less
than
monthly
Never
Less
than
monthly
Never
Less
than
monthly
Never
Less
than
monthly
Have you or somebody else been
injured as a result of your drinking?
No
Has a relative or friend, doctor or
other health worker been concerned
about your drinking or suggested
that you cut down?
No
Scoring: 0 – 7 Lower risk, 8 – 15 Increasing risk,
16 – 19 Higher risk, 20+ Possible dependence
2
Monthly
Monthly
Monthly
Monthly
Monthly
Your
score
3
4
Weekly
Daily
or
almost
daily
Weekly
Daily
or
almost
daily
Weekly
Daily
or
almost
daily
Weekly
Daily
or
almost
daily
Weekly
Daily
or
almost
daily
Yes,
but not
in the
last
year
Yes,
but not
in the
last
year
Yes,
during
the
last
year
Yes,
during
the
last
year
TOTAL
= =
TOTAL Score equals
Page 5 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
AUDIT C Score (above) + Score of remaining questions
4.2 Lifestyle Questionnaires: Smoking
What is your current smoking status?
Non smoker
Ex-smoker
Light smoker (9 or less
cigarettes a day)
Moderate smoker (between
10-19 cigarettes a day)
Heavy smoker (20 or
more cigarettes a day)
If you are a light, moderate or heavy smoker; how many cigarettes do you smoke a day?
Page 6 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
4.3 Lifestyle Questionnaires: DINE and Healthy Eating
DINE: Dietary Instrument for Nutrition Education
1.
About how many pieces or slices per day do you eat of the following types of
bread, rolls, or chapatis? (Choose one answer on each line)
None
Less
than 1 a
day
1 to 2
a day
3 to 4
a day
5 or
more a
day
White bread or rolls
0
1
4
9
13
Brown or granary bread or rolls
0
2
7
15
22
Wholemeal bread or rolls
0
3
8
18
26
Breads & Rolls
Bread
2. About how many servings per week do you eat of the following types of
breakfast cereal or porridge? (Choose one answer on each line)
None
Less
than 1
a week
1 to 2
a week
3 to 5
a week
6 or
more a
week
Sugared type: Frosties, Coco Pops,
Ricicles, Sugar Puffs
Rice or Corn type: Corn Flakes, Rice
Krispies, Special K
0
0
0
1
2
Porridge or Ready Brek
Wheat type: Shredded Wheat, Start,
Weetabix, Fruit ‘n Fibre, Puffed Wheat
Muesli type: Alpen, Jordans
0
1
2
5
7
Bran type: All-Bran, Bran Flakes, Country
Bran
0
Breakfast cereals
Cereal
2
5
12
18
3. About how many servings per week do you eat of the following foods?
(Choose one answer on each line)
None
Less
than 1
a week
1 to 2
a week
3 to 5
a week
6 to 7
a week
8 to 11
a week
12 or
more a
week
Pasta or rice
0
0
1
3
4
6
8
Potatoes
0
0
1
3
5
8
10
Peas
1
1
3
8
12
16
24
Beans (baked, tinned,
1
1
4
10
15
20
30
Vegetable foods
Page 7 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
or dried) or lentils
Other vegetables
(any type)
0
0
1
2
3
5
6
Fruit (fresh, frozen, or
canned)
0
0
1
3
5
8
10
Less than 30
=
Low Fibre Intake
30 to 40
=
Medium Fibre Intake
More than 40
=
High Fibre Intake
Fibre Rating
Vegetabl
es
Total
4. About how many servings per week do you eat of the following foods?
(Choose one answer on each line)
None
Less
than 1 a
week
1 to 2
a week
3 to 5
a week
6 or
more a
week
Cheese (any except cottage)
1
1
2
6
9
Beefburgers or sausages
1
1
2
4
6
Beef, pork, or lamb
(for vegetarians: nuts)
1
1
2
6
9
Bacon, meat pie, processed meat
1
1
2
5
8
Chicken or turkey
0
0
1
3
5
Fish (NOT fried fish)
0
0
0
1
2
ANY fried food: fried fish, chips,
cooked breakfast, samosas
1
1
2
6
9
Cakes, pies, puddings, pastries
1
1
2
5
8
Biscuits, chocolate, or crisps
1
1
2
4
6
Score
5. About how much of the following types of milk do you yourself use per day,
for example in cereal, tea, or coffee? (Choose one answer on each line)
Milk
Full cream (blue top) or
Channel Islands (gold top)
Semi-skimmed (green top)
None
Less
than a
quarter
pint
About a
quarter
pint
About
half a
pint
1 pint or
more
0
1
3
6
12
0
0
1
3
6
Milk
Page 8 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Skimmed (red top)
Participant Identification Number
0
0
0
0
0
6. About how many rounded teaspoons per day do you usually use of the following
types of spreads, for example on bread, sandwiches, toast, potatoes, or
vegetables? (Choose one answer on each line)
Spreads
Regular margarine or butter or
Reduced fat spread such as
sunflower or olive spread, Flora,
Vitalite, Clover, Olivio, Stork,
Utterly Butterly
Low fat spread such as
Flora Light, Flora Pro-activ, Light
spread
Fat Rating
None
1
2
3
4
5
6
7 or
more
0
4
8
12
16
20
24
28
Spread
0
2
4
6
8
10
Less than 30
=
Low Fat Intake
30 to 40
=
Medium Fat Intake
More than 40
=
High Fat Intake
12
14
Total
Page 9 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
7. What type of fat do you usually use for the following purposes?
(Choose one answer on each line)
Butter,
lard, or
dripping
Solid cooking fat
Soft margarine
Half-fat butter
Hard margarine
Vegetable oil or Low
fat spread
No fat
used
Reduced fat spread
On bread and
vegetables
1
2
3
4
3
For frying
1
2
3
4
3
For baking or
cooking
1
2
3
4
3
Unsaturated Fat
Rating
Less than 6
=
Low Unsaturated Fat
6 to 9
=
Medium Unsaturated Fat
Total
Additional diet questions
How many pieces of fruit, of any sort, do you eat on a typical day?
(eg an apple or banana, a small bowl of strawberries, three tablespoons of tinned fruit, at least
one glass of fresh fruit juice)
How many portions of vegetables, excluding potatoes, do you eat on a typical day?
(e.g. four heaped teaspoons of green vegetables such as spinach, three heaped spoonfuls of fresh,
tinned or frozen vegetables (such as carrots), one medium tomato, three heaped teaspoons of
beans or chickpeas.)
Page 10 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Section 5
5.1 Medical Records: Risk Scores
Has a 10-Year QRISK®2 Score been recorded in the last 12 months?
YES
NO
If yes,
10-Year QRISK®2 Score recorded in last 12 months
.
%
Date the 10-Year QRISK®2 Score was recorded in the last 12 months
D
D
M
M
Y
Y
Y
Y
Has a 10-Year Framingham Score been recorded in the last 12 months?
YES
NO
If yes,
10-Year Framingham Score recorded in last 12 months
.
%
Date the 10-Year Framingham Score recorded in the last 12 months
D
D
M
M
Y
Y
Y
Y
5.2 Medical Records: Alcohol History
Alcohol history
Has there been a recorded history of heavy drinking or
alcohol problems in the last 12 months?
If yes, date history of heavy drinking or alcohol problems
YES
D
D
NO
M
M
Y
Y
Y
Y
recorded
Number of units of alcohol consumed per week
Page 11 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Date number of units of alcohol consumed per week recorded
D
D
M
M
Y
Y
Y
Y
Alcohol intake/hazardous or harmful drinking
Number of times alcohol intake/hazardous or harmful drinking has been checked by a doctor in
the past 12 months
Number of times alcohol intake/hazardous or harmful drinking has been checked by a nurse in the
past 12 months
Number of times alcohol intake/hazardous or harmful drinking has been checked by a healthcare
assistant in the past 12 months
5.3 Medical Records: Physical Health Conditions
Diagnosed physical health conditions
Diagnosis of Type 1 diabetes?
YES
NO
Diagnosis of Type 2 diabetes?
YES
NO
Receiving treatment for
hypertension?
YES
NO
Angina or heart attack in a 1st
degree relative under the age
of 60?
YES
NO
Chronic kidney disease?
YES
NO
Atrial fibrillation?
YES
NO
Not known
Page 12 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Rheumatoid arthritis?
YES
NO
Left ventricular hypertrophy?
YES
NO
Other diagnosed major active long term conditions in the following
systems: Respiratory, gastroenterology, neurology, chronic infections,
endocrinology and skin in the last 12 months.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Date of diagnosis
(dd/mm/yyyy)
Page 13 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.4 Medical Records: Hospital Based Service Receipt: Overnight Inpatient
Stays
Overnight inpatient stays in the last 12 months
Inpatient Service Type
Dates of admissions in the last 12
months
Total
number of
nights in
hospital
Reason for Admission
Psychiatric intensive
care ward
Acute psychiatric ward
Psychiatric
rehabilitation ward
General medical
elective/planned
inpatient admission
General medical nonelective/unplanned
inpatient admission
General medical
intensive care/High
dependency unit
Page 14 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.5 Medical Records: Hospital Based Service Receipt: Outpatient
Appointments
Outpatient appointments attended in the last 12 months
Outpatient Service
Type
Dates of contacts in the last 12
months
Reason for attendance
Psychiatric outpatient
appointment
Day patient
procedure/test
General medical
outpatient
appointment
Page 15 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.6 Medical Records: Hospital Based Service Receipt: Accident and
Emergency (A&E) Attendances
A&E service attended in the last 12 months
Accident and
Emergency attendance
Dates of contacts in the last 12
months
Reason for attendance
And admitted to
hospital
Not admitted to
hospital
5.7 Medical Records: Community Based Service Receipt: General Practice
General practice services attended in the last 12 months
GP Practice Service Type
Dates of contacts
(where available)
Date of first contact
with service.
Date discharged
from service
in the last 6months
(if service used during
last 16 months)
(services used during
last 6 months)
General practitioner
Practice Nurse
Healthcare Assistant
Other practice staff (please
specify)
Page 16 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.8 Medical Records: Community Based Service Receipt: Other Community
Based Services
Other community based services attended in the last 12 months
For the following services please fill in dates of contacts if known, otherwise the first and last dates
that the patient engaged with the service for services that the patient has been in contact with in
the last 12 months.
Other Community Based
Service Type
Dates of contacts
(where available)
Date of first contact
with service
Date discharged
from service
(in the last 12
months)
(if services used
during last 12
months)
(if services used
during last 12
months)
Dates of contacts
(where available)
Date of first contact
with service
Date discharged
from service
(in the last 12months)
(if services used
during last
12months)
(if services used
during last
12months)
IAPT or other CBT services
Community psychiatrist
(excluding outpatient visits)
Other Community Based
Service Type
Psychologist
Community psychiatric nurse
CPA key worker
Case Manager
Community mental health
Page 17 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
team
Learning disability service
Other community nurse
(eg district nurse, health
visitor)
Other services used (please
specify)
5.9 Medical Records: Health Checks and Health Action Plans
Number of times physical health checks carried out
Blood pressure
No times checked by Doctor in the past 12 months
[
]
No times checked by Nurse in the past 12 months
[
]
No times checked by healthcare assistant in the past 12 months
[
Blood cholesterol
]
No times checked by Doctor in the past 12 months
[
]
No times checked by Nurse in the past 12 months
[
]
No times checked by healthcare assistant in the past 12 months
[
Blood sugar and/or HBA1c
]
No times checked by Doctor in the past 12 months
[
]
Page 18 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
No times checked by Nurse in the past 12 months
[
]
No times checked by healthcare assistant in the past 12 months
[
Weight and BMI
]
No times checked by Doctor in the past 12 months
[
]
No times checked by Nurse in the past 12 months
[
]
No times checked by healthcare assistant in the past 12 months
[
Smoking status
]
No times checked by Doctor in the past 12 months
[
]
No times checked by Nurse in the past 12 months
[
]
No times checked by healthcare assistant in the past 12 months
[
]
Page 19 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Health action plan
In the past 12 months has a health action plan for any problematic areas been developed with the
patient? (Problematic areas arising from the NHS health check)
YES
NO
If yes, please complete the following (for problem areas arising from the health check):
Problem area addressed: Cholesterol
YES
NO
Problem area addressed: Blood pressure
YES
NO
Problem area addressed: Pre-diabetes
YES
NO
Problem area addressed: Diabetes
YES
NO
Problem area addressed: Smoking
YES
NO
Problem area addressed: Weight
YES
NO
Problem area addressed: Alcohol
YES
NO
Problem area addressed: Other
YES
NO
If other, please specify
In the past 12 months has the patient been referred to any services for problematic areas resulting
from their health check?
YES
NO
Page 20 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
If yes,
Service patient referred to as a result of their health check (Tick all that apply)
NHS diabetes management services
NHS stop smoking services
NHS weight management services
NHS alcohol services
Other
If Other, please specify
Page 21 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.10 Medical Records: Prescribed Medication
Complete for all medications received in the last 12 months. If the dose changes, record this again in a separate row. If you run out of space
record this in the “other medications” row.
Drug name
Dose
Units of
dose
(e.g. mg)
Frequency
(e.g. three
times
daily)
Date first
prescribed
(DD/MM/YYYY)
Duration of
prescription
Reason for
prescription
Has the
medication
been
discontinued?
Please state Yes
or No
If yes, please give
reason/s for
stopping
Antipsychotics
Antidepressants
Mood stabilisers
Page 22 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Statins
Antihypertensives
Metformin
Other diabetic medications
Page 23 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
Stop smoking medications (e.g Varenicline or Bupoprion)
Other medications
Page 24 of 25
NIHR PROJECT: RP-PG-0609-10156
The PRIMROSE Study
Twelve month follow up CRF/VN3:/25/02/2015
Participant Identification Number
5.11 Medical records : appointment DNA’s
How many scheduled appointments with a GP, practice nurse, healthcare assistant or other practice staff were there in the last 12 months?
How many of these scheduled appointments did the participant NOT attend (DNA)?
Has the patient been identified by the GP practice as a frequent non-attender?
YES
NO
Research Nurse Blinding
Do you think that this patient
Received the PRIMROSE service (intervention group)
Received treatment as usual (control group)
Page 25 of 25
NIHR PROJECT: RP-PG-0609-10156