ID

37311

Beskrivning

GMVs in Primary Care: An RCT of Group-Based Versus Individual Appointments to Reduce HbA1c in Older People; ODM derived from: https://clinicaltrials.gov/show/NCT02002143

Länk

https://clinicaltrials.gov/show/NCT02002143

Nyckelord

Versioner (1)
  1. 2019-07-15 2019-07-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus (T2DM) NCT02002143

Engelsk

Eligibility Type 2 Diabetes Mellitus (T2DM) NCT02002143

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
aged ≥ 65 years old;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have at least a 12-month history of t2dm based on the canadian diabetes guidelines;
Beskrivning

Non-Insulin-Dependent Diabetes Mellitus Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
be community-dwelling;
Beskrivning

Community Dwelling

Datatyp

boolean

Alias
UMLS CUI [1]
C4045975
live within 30km of their gp clinic in abbotsford, bc (canada);
Beskrivning

Residence Nearby

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
able to comply with scheduled visits, treatment plan, and other trial procedures;
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
read, write, and speak english;
Beskrivning

Able to read English Language | Able to write English Language | Able to speak English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0564215
UMLS CUI [3,2]
C0376245
acceptable auditory acuity to participate in the group appointments and visual acuity to participate in the research;
Beskrivning

Auditory acuity Acceptable | Visual Acuity Acceptable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0679027
UMLS CUI [1,2]
C1879533
UMLS CUI [2,1]
C0042812
UMLS CUI [2,2]
C1879533
provide a personally signed and dated informed consent;
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
able to walk independently;
Beskrivning

Able to walk Independent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C1299583
inclusion will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician, indicating the patient's appropriateness to participate.
Beskrivning

Medical History | Vital signs | Physical Examination | Study Subject Participation Status Appropriateness

Datatyp

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0518766
UMLS CUI [3]
C0031809
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0814634
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
using insulin to treat diabetes to increase the homogeneity of the sample;
Beskrivning

Insulin regime Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011849
at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., class c of the american heart risk stratification criteria);
Beskrivning

High risk of Cardiac complication During Exercise | Physical activity Regulation Unable | Comprehension Activity level Recommended Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332167
UMLS CUI [1,2]
C0161816
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0015259
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0851285
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0162340
UMLS CUI [3,2]
C0683317
UMLS CUI [3,3]
C0034866
UMLS CUI [3,4]
C1299582
mini-mental state examination (mmse)[51] score of ≤ 24 at screening;
Beskrivning

Mini-mental state examination

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
Beskrivning

Peripheral Neuropathy | Musculoskeletal Disease Severe | Arthropathy Severe | Impaired mobility

Datatyp

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2,1]
C0026857
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0022408
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0518456
taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
Beskrivning

Pharmaceutical Preparations Impairing Walking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0080331
planning to participate, or already enrolled in, a clinical drug trial concurrent to this study.
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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Similar models

Eligibility Type 2 Diabetes Mellitus (T2DM) NCT02002143

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
aged ≥ 65 years old;
boolean
C0001779 (UMLS CUI [1])
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
have at least a 12-month history of t2dm based on the canadian diabetes guidelines;
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Community Dwelling
Item
be community-dwelling;
boolean
C4045975 (UMLS CUI [1])
Residence Nearby
Item
live within 30km of their gp clinic in abbotsford, bc (canada);
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
Protocol Compliance
Item
able to comply with scheduled visits, treatment plan, and other trial procedures;
boolean
C0525058 (UMLS CUI [1])
Able to read English Language | Able to write English Language | Able to speak English Language
Item
read, write, and speak english;
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0564215 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Auditory acuity Acceptable | Visual Acuity Acceptable
Item
acceptable auditory acuity to participate in the group appointments and visual acuity to participate in the research;
boolean
C0679027 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
C0042812 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
Informed Consent
Item
provide a personally signed and dated informed consent;
boolean
C0021430 (UMLS CUI [1])
Able to walk Independent
Item
able to walk independently;
boolean
C2712089 (UMLS CUI [1,1])
C1299583 (UMLS CUI [1,2])
Medical History | Vital signs | Physical Examination | Study Subject Participation Status Appropriateness
Item
inclusion will be based on medical history, vital signs, physical examination by study physicians, and written recommendation by family physician, indicating the patient's appropriateness to participate.
boolean
C0262926 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0814634 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Insulin regime Diabetes Mellitus
Item
using insulin to treat diabetes to increase the homogeneity of the sample;
boolean
C0557978 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
High risk of Cardiac complication During Exercise | Physical activity Regulation Unable | Comprehension Activity level Recommended Unable
Item
at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., class c of the american heart risk stratification criteria);
boolean
C0332167 (UMLS CUI [1,1])
C0161816 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0015259 (UMLS CUI [1,4])
C0026606 (UMLS CUI [2,1])
C0851285 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0162340 (UMLS CUI [3,1])
C0683317 (UMLS CUI [3,2])
C0034866 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
Mini-mental state examination
Item
mini-mental state examination (mmse)[51] score of ≤ 24 at screening;
boolean
C0451306 (UMLS CUI [1])
Peripheral Neuropathy | Musculoskeletal Disease Severe | Arthropathy Severe | Impaired mobility
Item
have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility;
boolean
C0031117 (UMLS CUI [1])
C0026857 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022408 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0518456 (UMLS CUI [4])
Pharmaceutical Preparations Impairing Walking
Item
taking medications that may negatively affect the ability to undertake a simple walking program safely (e.g. beta blockers);
boolean
C0013227 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
planning to participate, or already enrolled in, a clinical drug trial concurrent to this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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