ID

19325

Beskrivning

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.

Nyckelord

  1. 2016-12-19 2016-12-19 -
  2. 2017-02-04 2017-02-04 -
Uppladdad den

19 december 2016

DOI

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Creative Commons BY-NC 3.0

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Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

General Information
Beskrivning

General Information

Assessment Date
Beskrivning

Assessment Date

Datatyp

date

In general, my Present quality of life is:
Beskrivning

Present quality of life

Datatyp

text

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

Quality of life without diabetes

Datatyp

text

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

Leisure activites wihtout diabetes

Datatyp

text

My leisure activities are
Beskrivning

Leisure activities

Datatyp

text

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

Work

Datatyp

boolean

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

Work life without diabetes

Datatyp

text

For me, having a working life is:
Beskrivning

Importance of work life

Datatyp

text

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

Long distance journeys without diabetes

Datatyp

text

For me, long distance journeys are:
Beskrivning

Long distance journeys with diabetes

Datatyp

text

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

Holidays

Datatyp

boolean

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

Holidays without diabetes

Datatyp

text

For me, holidays are:
Beskrivning

Holidays with diabetes

Datatyp

text

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

Physical condition without diabetes

Datatyp

text

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

Physical condition with diabetes

Datatyp

text

Do you have any family/relatives?
Beskrivning

Family

Datatyp

boolean

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

Family without diabetes

Datatyp

text

My family life is
Beskrivning

Family with diabetes

Datatyp

text

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

Friendships and social life without diabetes

Datatyp

text

My friendships and social life are:
Beskrivning

Friendships and social life with diabetes

Datatyp

text

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

Close personal relationship

Datatyp

boolean

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

Close personal relationship without diabetes

Datatyp

text

For me, having a close personal relationship is:
Beskrivning

Close personal relationship with diabetes

Datatyp

text

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

Sex life

Datatyp

boolean

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

Sex life without diabetes

Datatyp

text

For me, having sex is:
Beskrivning

Sex life with diabetes

Datatyp

text

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

Physical appearance without diabetes

Datatyp

text

My physical appearance is:
Beskrivning

Physical appearance with diabetes

Datatyp

text

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

Self-confidence without diabetes

Datatyp

text

My self-confidence is:
Beskrivning

Self-confidence with diabetes

Datatyp

text

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

Motivation without diabetes

Datatyp

text

My motivation is:
Beskrivning

Motivation with diabetes

Datatyp

text

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

Feelings about the future without diabetes

Datatyp

text

My feelings about the future are:
Beskrivning

Feelings about the future with diabetes

Datatyp

text

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

Financial situation without diabetes

Datatyp

text

My financial situation is:
Beskrivning

Financial situation with diabetes

Datatyp

text

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

Living conditions without diabetes

Datatyp

text

My living conditions are:
Beskrivning

Living conditions with diabetes

Datatyp

text

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

Depending on others

Datatyp

text

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

Not depending on others

Datatyp

text

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

Freedom to eat without diabetes

Datatyp

text

My freedom to eat as I wish is:
Beskrivning

Freedom to eat with diabetes

Datatyp

text

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

Freedom to drink without diabetes

Datatyp

text

My freedom to drink as I wish is:
Beskrivning

Freedom to drink with diabetes

Datatyp

text

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

Affect on quality of life

Datatyp

text

Similar models

Visit 9 Follow-up ADDQoL [QS_2] NCT01117584

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General Information
Assessment Date
Item
Assessment Date
date
Item
In general, my Present quality of life is:
text
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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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