ID

37339

Beskrivning

REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT02320253

Länk

https://clinicaltrials.gov/show/NCT02320253

Nyckelord

Versioner (1)
  1. 2019-07-18 2019-07-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02320253

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02320253

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
age 18 years or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
overweight or obese (bmi >25 kg/m2)
Beskrivning

Overweight | Obesity | Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C0497406
UMLS CUI [2]
C0028754
UMLS CUI [3]
C1305855
hba1c level 7<11%
Beskrivning

Hemoglobin A1c measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0474680
systolic blood pressure (sbp) <160 mmhg, diastolic blood pressure (dbp) <100 mmhg
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
triglyceride levels <600 mg/dl
Beskrivning

Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
taking metformin or have a metformin allergy or intolerance
Beskrivning

Metformin | Metformin allergy | Intolerance to Metformin

Datatyp

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0571648
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0025598
willing to lose 5-7% of body weight
Beskrivning

Weight lose Percentage Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0600109
willing to increase activity to at least 175 minutes/week
Beskrivning

Increase in physical activity mins/week Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3694428
UMLS CUI [1,2]
C0556975
UMLS CUI [1,3]
C0600109
willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to nutrition services for medical nutrition therapy
Beskrivning

Random assignment | Lifestyle change therapy | Nutrition Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0814868
UMLS CUI [2]
C2960841
UMLS CUI [3]
C2937349
stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
Beskrivning

Health Stable | Absence Comorbidity Severe | Comorbidity Interferes with Interventional procedure | Absence Mental disorder Severe | Absence Heart Disease Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0009488
UMLS CUI [2,3]
C0205082
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0184661
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0004936
UMLS CUI [4,3]
C0205082
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0018799
UMLS CUI [5,3]
C0750502
ability to understand and communicate effectively in english or spanish
Beskrivning

Comprehension English Language | Able to communicate English Language | Comprehension Spanish Language | Able to communicate Spanish Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233733
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C2364293
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0233733
UMLS CUI [3,2]
C0037750
UMLS CUI [4,1]
C2364293
UMLS CUI [4,2]
C0037750
willing to self-monitor blood glucose
Beskrivning

Blood Glucose Self-Monitoring

Datatyp

boolean

Alias
UMLS CUI [1]
C0005803
willing to keep a food, exercise, and blood glucose diary
Beskrivning

Subject Diary Completion | Food Diary | Exercise Diary | Blood Glucose Diary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0016452
UMLS CUI [2,2]
C3890583
UMLS CUI [3,1]
C0015259
UMLS CUI [3,2]
C3890583
UMLS CUI [4,1]
C0005802
UMLS CUI [4,2]
C3890583
have a primary care physician at mgh chelsea, charlestown, or revere health centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider
Beskrivning

Primary Care Physician | Pharmaceutical Preparations Adjustment | Clinic Visits Health center

Datatyp

boolean

Alias
UMLS CUI [1]
C0033131
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0456081
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0475309
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
weight greater than 350 pounds
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
pregnant or planning pregnancy in the next year
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program
Beskrivning

Follow-up Regular Dietitian | Participation Weight Reduction Program

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0205272
UMLS CUI [1,3]
C3536818
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C3179079
weight change of more than 5 pounds in the previous 3 months.
Beskrivning

Weight Change Amount Timespan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005911
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
currently enrolled in another diabetes study
Beskrivning

Study Subject Participation Status | Clinical Trial Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0011849
lack of availability of telephone
Beskrivning

Lacking Availability of Telephone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0039457
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02320253

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Age
Item
age 18 years or older
boolean
C0001779 (UMLS CUI [1])
Overweight | Obesity | Body mass index
Item
overweight or obese (bmi >25 kg/m2)
boolean
C0497406 (UMLS CUI [1])
C0028754 (UMLS CUI [2])
C1305855 (UMLS CUI [3])
Hemoglobin A1c measurement
Item
hba1c level 7<11%
boolean
C0474680 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure
Item
systolic blood pressure (sbp) <160 mmhg, diastolic blood pressure (dbp) <100 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Triglycerides measurement
Item
triglyceride levels <600 mg/dl
boolean
C0202236 (UMLS CUI [1])
Metformin | Metformin allergy | Intolerance to Metformin
Item
taking metformin or have a metformin allergy or intolerance
boolean
C0025598 (UMLS CUI [1])
C0571648 (UMLS CUI [2])
C1744706 (UMLS CUI [3,1])
C0025598 (UMLS CUI [3,2])
Weight lose Percentage Willing
Item
willing to lose 5-7% of body weight
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Increase in physical activity mins/week Willing
Item
willing to increase activity to at least 175 minutes/week
boolean
C3694428 (UMLS CUI [1,1])
C0556975 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Random assignment | Lifestyle change therapy | Nutrition Therapy
Item
willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to nutrition services for medical nutrition therapy
boolean
C0814868 (UMLS CUI [1])
C2960841 (UMLS CUI [2])
C2937349 (UMLS CUI [3])
Health Stable | Absence Comorbidity Severe | Comorbidity Interferes with Interventional procedure | Absence Mental disorder Severe | Absence Heart Disease Significant
Item
stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
boolean
C0018684 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0184661 (UMLS CUI [3,3])
C0332197 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0018799 (UMLS CUI [5,2])
C0750502 (UMLS CUI [5,3])
Comprehension English Language | Able to communicate English Language | Comprehension Spanish Language | Able to communicate Spanish Language
Item
ability to understand and communicate effectively in english or spanish
boolean
C0233733 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0233733 (UMLS CUI [3,1])
C0037750 (UMLS CUI [3,2])
C2364293 (UMLS CUI [4,1])
C0037750 (UMLS CUI [4,2])
Blood Glucose Self-Monitoring
Item
willing to self-monitor blood glucose
boolean
C0005803 (UMLS CUI [1])
Subject Diary Completion | Food Diary | Exercise Diary | Blood Glucose Diary
Item
willing to keep a food, exercise, and blood glucose diary
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0016452 (UMLS CUI [2,1])
C3890583 (UMLS CUI [2,2])
C0015259 (UMLS CUI [3,1])
C3890583 (UMLS CUI [3,2])
C0005802 (UMLS CUI [4,1])
C3890583 (UMLS CUI [4,2])
Primary Care Physician | Pharmaceutical Preparations Adjustment | Clinic Visits Health center
Item
have a primary care physician at mgh chelsea, charlestown, or revere health centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider
boolean
C0033131 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0456081 (UMLS CUI [2,2])
C0008952 (UMLS CUI [3,1])
C0475309 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Body Weight
Item
weight greater than 350 pounds
boolean
C0005910 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning pregnancy in the next year
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Follow-up Regular Dietitian | Participation Weight Reduction Program
Item
currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program
boolean
C1522577 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3536818 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C3179079 (UMLS CUI [2,2])
Weight Change Amount Timespan
Item
weight change of more than 5 pounds in the previous 3 months.
boolean
C0005911 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial Diabetes Mellitus
Item
currently enrolled in another diabetes study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
Lacking Availability of Telephone
Item
lack of availability of telephone
boolean
C0332268 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0039457 (UMLS CUI [1,3])
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