ID

19325

Descrizione

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Keywords

versioni (2)
  1. 19/12/16 19/12/16 -
  2. 04/02/17 04/02/17 -
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19 dicembre 2016

DOI

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Creative Commons BY-NC 3.0
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Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

Inglese

Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

1 moduli  
General Information
Descrizione

General Information

Assessment Date
Descrizione

Assessment Date

Tipo di dati

date

In general, my Present quality of life is:
Descrizione

Present quality of life

Tipo di dati

text

If I did not have diabetes, my quality of life woud be:
Descrizione

Quality of life without diabetes

Tipo di dati

text

If I did not have diabetes, I would enjoy my leisure activities:
Descrizione

Leisure activites wihtout diabetes

Tipo di dati

text

My leisure activities are
Descrizione

Leisure activities

Tipo di dati

text

Are you currently working, looking for work or would you like to work?
Descrizione

Work

Tipo di dati

boolean

If I did not have diabetes, my work life would be:
Descrizione

Work life without diabetes

Tipo di dati

text

For me, having a working life is:
Descrizione

Importance of work life

Tipo di dati

text

If I did not have diabetes, local or long distance journeys would be:
Descrizione

Long distance journeys without diabetes

Tipo di dati

text

For me, long distance journeys are:
Descrizione

Long distance journeys with diabetes

Tipo di dati

text

Did you ever go on holiday or want to go on holiday?
Descrizione

Holidays

Tipo di dati

boolean

If I did not have diabetes, my holidays would be:
Descrizione

Holidays without diabetes

Tipo di dati

text

For me, holidays are:
Descrizione

Holidays with diabetes

Tipo di dati

text

If I did not have diabetes, physically I could do:
Descrizione

Physical condition without diabetes

Tipo di dati

text

For me, how much I can do physically is:
Descrizione

Physical condition with diabetes

Tipo di dati

text

Do you have any family/relatives?
Descrizione

Family

Tipo di dati

boolean

If I did not have diabetes, my family life would be:
Descrizione

Family without diabetes

Tipo di dati

text

My family life is
Descrizione

Family with diabetes

Tipo di dati

text

If I did not have diabetes, my friendships and social life would be:
Descrizione

Friendships and social life without diabetes

Tipo di dati

text

My friendships and social life are:
Descrizione

Friendships and social life with diabetes

Tipo di dati

text

Do you have a close personal relationship (e.g husband/wife, partner)?
Descrizione

Close personal relationship

Tipo di dati

boolean

If I did not have diabetes, my closest personal relationship would be:
Descrizione

Close personal relationship without diabetes

Tipo di dati

text

For me, having a close personal relationship is:
Descrizione

Close personal relationship with diabetes

Tipo di dati

text

Do you or would you like to have a sex life?
Descrizione

Sex life

Tipo di dati

boolean

If I did not have diabetes, my sex life would be
Descrizione

Sex life without diabetes

Tipo di dati

text

For me, having sex is:
Descrizione

Sex life with diabetes

Tipo di dati

text

If I did not have diabetes, my physical appearance would be:
Descrizione

Physical appearance without diabetes

Tipo di dati

text

My physical appearance is:
Descrizione

Physical appearance with diabetes

Tipo di dati

text

If I did not have diabetes, my self-confidence would be:
Descrizione

Self-confidence without diabetes

Tipo di dati

text

My self-confidence is:
Descrizione

Self-confidence with diabetes

Tipo di dati

text

If I did not have diabetes, my motivation would be:
Descrizione

Motivation without diabetes

Tipo di dati

text

My motivation is:
Descrizione

Motivation with diabetes

Tipo di dati

text

If I did not have diabetes, my future would be
Descrizione

Feelings about the future without diabetes

Tipo di dati

text

My feelings about the future are:
Descrizione

Feelings about the future with diabetes

Tipo di dati

text

If I did not have diabetes, my financial situation would be
Descrizione

Financial situation without diabetes

Tipo di dati

text

My financial situation is:
Descrizione

Financial situation with diabetes

Tipo di dati

text

If I did not have diabetes, my living conditions would be
Descrizione

Living conditions without diabetes

Tipo di dati

text

My living conditions are:
Descrizione

Living conditions with diabetes

Tipo di dati

text

If I did not have diabetes, I would have to depend on others when I do not want to:
Descrizione

Depending on others

Tipo di dati

text

For me, not having to depend on others is:
Descrizione

Not depending on others

Tipo di dati

text

If I did not have diabetes, my freedom to eat as I wish would be:
Descrizione

Freedom to eat without diabetes

Tipo di dati

text

My freedom to eat as I wish is:
Descrizione

Freedom to eat with diabetes

Tipo di dati

text

If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
Descrizione

Freedom to drink without diabetes

Tipo di dati

text

My freedom to drink as I wish is:
Descrizione

Freedom to drink with diabetes

Tipo di dati

text

Any other ways in which diabetes and its management and any complications affect your quality of life:
Descrizione

Affect on quality of life

Tipo di dati

text

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Similar models

Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
General Information
Assessment Date
Item
Assessment Date
date
Item
In general, my Present quality of life is:
text
Present quality of life
Code List
In general, my Present quality of life is:
CL Item
excellent (1)
CL Item
very good (2)
CL Item
good (3)
CL Item
neither good nor bad  (4)
CL Item
bad (5)
CL Item
very bad (6)
CL Item
extremely bad (7)
Item
If I did not have diabetes, my quality of life woud be:
text
Quality of life without diabetes
Code List
If I did not have diabetes, my quality of life woud be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
If I did not have diabetes, I would enjoy my leisure activities:
text
Leisure activites wihtout diabetes
Code List
If I did not have diabetes, I would enjoy my leisure activities:
CL Item
very much more  (1)
CL Item
much more (2)
CL Item
a little more  (3)
CL Item
the same  (4)
CL Item
less (5)
Item
My leisure activities are
text
My leisure activities are
Code List
My leisure activities are
CL Item
very important  (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Work
Item
Are you currently working, looking for work or would you like to work?
boolean
Item
If I did not have diabetes, my work life would be:
text
Work life without diabetes
Code List
If I did not have diabetes, my work life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having a working life is:
text
Importance of work life
Code List
For me, having a working life is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, local or long distance journeys would be:
text
Long distance journeys without diabetes
Code List
If I did not have diabetes, local or long distance journeys would be:
CL Item
very much easier (1)
CL Item
much easier (2)
CL Item
a little easier (3)
CL Item
the same (4)
CL Item
more difficult (5)
Item
For me, long distance journeys are:
text
Long distance journeys with diabetes
Code List
For me, long distance journeys are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Holidays
Item
Did you ever go on holiday or want to go on holiday?
boolean
Item
If I did not have diabetes, my holidays would be:
text
Holidays without diabetes
Code List
If I did not have diabetes, my holidays would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, holidays are:
text
Holidays with diabetes
Code List
For me, holidays are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, physically I could do:
text
Physical condition without diabetes
Code List
If I did not have diabetes, physically I could do:
CL Item
very much more (1)
CL Item
much more (2)
CL Item
a little more (3)
CL Item
the same (4)
CL Item
less (5)
Item
For me, how much I can do physically is:
text
Physical condition with diabetes
Code List
For me, how much I can do physically is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important  (3)
CL Item
not at all important (4)
Family
Item
Do you have any family/relatives?
boolean
Item
If I did not have diabetes, my family life would be:
text
Family without diabetes
Code List
If I did not have diabetes, my family life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My family life is
text
Family with diabetes
Code List
My family life is
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my friendships and social life would be:
text
Friendships and social life without diabetes
Code List
If I did not have diabetes, my friendships and social life would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My friendships and social life are:
text
Freindships and social life with diabetes
Code List
My friendships and social life are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Close personal relationship
Item
Do you have a close personal relationship (e.g husband/wife, partner)?
boolean
Item
If I did not have diabetes, my closest personal relationship would be:
text
Close personal relationship without diabetes
Code List
If I did not have diabetes, my closest personal relationship would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having a close personal relationship is:
text
Close personal relationship with diabetes
Code List
For me, having a close personal relationship is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Sex life
Item
Do you or would you like to have a sex life?
boolean
Item
If I did not have diabetes, my sex life would be
text
Sex life without diabetes
Code List
If I did not have diabetes, my sex life would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
For me, having sex is:
text
Sex life with diabetes
Code List
For me, having sex is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my physical appearance would be:
text
Physical appearance without diabetes
Code List
If I did not have diabetes, my physical appearance would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My physical appearance is:
text
Physical appearance with diabetes
Code List
My physical appearance is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my self-confidence would be:
text
Self-confidence without diabetes
Code List
If I did not have diabetes, my self-confidence would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My self-confidence is:
text
Self-confidence with diabetes
Code List
My self-confidence is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my motivation would be:
text
Motivation without diabetes
Code List
If I did not have diabetes, my motivation would be:
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My motivation is:
text
Motivation with diabetes
Code List
My motivation is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my future would be
text
Feelings about the future without diabetes
Code List
If I did not have diabetes, my future would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My feelings about the future are:
text
Feelings about the future with diabetes
Code List
My feelings about the future are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important  (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my financial situation would be
text
Financial situation without diabetes
Code List
If I did not have diabetes, my financial situation would be
CL Item
very much bettter (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My financial situation is:
text
Financial situation with diabetes
Code List
My financial situation is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my living conditions would be
text
Living conditions without diabetes
Code List
If I did not have diabetes, my living conditions would be
CL Item
very much better (1)
CL Item
much better (2)
CL Item
a little better (3)
CL Item
the same (4)
CL Item
worse (5)
Item
My living conditions are:
text
Living conditions with diabetes
Code List
My living conditions are:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, I would have to depend on others when I do not want to:
text
Depending on others
Code List
If I did not have diabetes, I would have to depend on others when I do not want to:
CL Item
very much less (1)
CL Item
much less (2)
CL Item
a little less (3)
CL Item
the same (4)
CL Item
more (5)
Item
For me, not having to depend on others is:
text
Not depending on others
Code List
For me, not having to depend on others is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my freedom to eat as I wish would be:
text
Freedom to eat without diabetes
Code List
If I did not have diabetes, my freedom to eat as I wish would be:
CL Item
very much greater (1)
CL Item
much greater (2)
CL Item
a little greater (3)
CL Item
the same (4)
CL Item
less (5)
Item
My freedom to eat as I wish is:
text
Freedom to eat with diabetes
Code List
My freedom to eat as I wish is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Item
If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
text
Freedom to drink without diabetes
Code List
If I did not have diabetes, my freedom to drink as I wish (e.g. fruit juice) would be:
CL Item
very much greater (1)
CL Item
much greater (2)
CL Item
a little greater (3)
CL Item
the same (4)
CL Item
less (5)
Item
My freedom to drink as I wish is:
text
Freedom to drink with diabetes
Code List
My freedom to drink as I wish is:
CL Item
very important (1)
CL Item
important (2)
CL Item
somewhat important (3)
CL Item
not at all important (4)
Affect on quality of life
Item
Any other ways in which diabetes and its management and any complications affect your quality of life:
text
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