ID

14913

Beschrijving

Diabetes CKD Lifestyle Technology Study; ODM derived from: https://clinicaltrials.gov/show/NCT02266823

Link

https://clinicaltrials.gov/show/NCT02266823

Trefwoorden

Versies (1)
  1. 08-05-16 08-05-16 -
Geüploaded op

8 mei 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02266823

Engels

Eligibility Chronic Kidney Disease NCT02266823

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
in order to be eligible for the study, the individual must be 40 years of age or older; have a drg code of t2dm, gfr of 15-89 ml/min/1.73m2 and a bmi >30 kg/m2. the participant's physician of record will have verified that his/her patient can safely participant in an intervention study that involves weight loss and a goal of 150 minutes/week of moderate physical activity (comparable to brisk walking).
Beschrijving

Age | Diagnosis-Related Groups | Diabetes Mellitus, Non-Insulin-Dependent | Glomerular Filtration Rate | Body mass index | Study Subject Participation Status | Clinical Trials | Weight decreased | Capable of moderate physical activity

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011928
UMLS CUI [3]
C0011860
UMLS CUI [4]
C0017654
UMLS CUI [5]
C1305855
UMLS CUI [6]
C2348568
UMLS CUI [7]
C0008976
UMLS CUI [8]
C1262477
UMLS CUI [9]
C3853097
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
those with the following characteristics will be excluded by the investigators:
Beschrijving

Exclusion Criteria Characteristics Following

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521970
UMLS CUI [1,3]
C0332282
1. unable or unwilling to provide informed consent; (2) unable to participate meaningfully in an intervention that involves group sessions (e.g., due to uncorrected hearing impairment, non-english-speaking); (3) unable to read or otherwise use an ipad to monitor dietary intake, physical activity, and weight (e.g., blind, illiterate); (4) unwilling to accept randomization assignment; (5) pregnant, or plans to become pregnant in the next 12 months, less than 3 months postpartum, or nursing or within 6 weeks of having completed nursing; (6) weight loss of > 10% in the past 6 months except for postpartum weight loss; and (7) individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have no control over their diet).
Beschrijving

Unable Informed Consent | Study Subject Participation Status Limited | hearing impairment | Able to speak English Language | Unable to read | Patient Monitoring Dietary intake Physical activity Body Weight | Blind Vision | Illiteracy | Unwilling Randomization | Pregnancy | Pregnancy, Planned | Postpartum Period | Breast Feeding | Weight decreased | Nursing Homes | CARE FACILITY PERSONAL CARE HOME PLACEMENT | Prisoners | Diet Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0439801
UMLS CUI [3]
C1384666
UMLS CUI [4,1]
C0564215
UMLS CUI [4,2]
C0376245
UMLS CUI [5]
C0586741
UMLS CUI [6,1]
C0030695
UMLS CUI [6,2]
C1286104
UMLS CUI [6,3]
C0026606
UMLS CUI [6,4]
C0005910
UMLS CUI [7]
C0456909
UMLS CUI [8]
C0020899
UMLS CUI [9,1]
C0558080
UMLS CUI [9,2]
C0034656
UMLS CUI [10]
C0032961
UMLS CUI [11]
C0032992
UMLS CUI [12]
C0086839
UMLS CUI [13]
C0006147
UMLS CUI [14]
C1262477
UMLS CUI [15]
C0028688
UMLS CUI [16]
C0741959
UMLS CUI [17]
C0033167
UMLS CUI [18,1]
C0012155
UMLS CUI [18,2]
C0205318
will exclude from the study those with underlying diseases which would increase the risk of participating in an intervention involving caloric restriction and physical activity. such individuals would include those requiring treatment for cancer, exclusive of skin cancer other than melanoma, in the past 2 years; infectious diseases including untreated aids and active tuberculosis; uncontrolled hypertension of >190 mmhg sbp or >105 mmhg dbp despite treatment; stroke or tia in the past 6 months; conditions requiring the use of home oxygen; or other chronic disease or condition likely to limit life span to < 1 year. a recent institute of medicine report suggests that reducing dietary sodium below 1,840 mg/day in those with mid- to late-stage heart failure may increase adverse events or mortality. thus investigators will exclude those with heart failure.
Beschrijving

Comorbidity | Study Subject Participation Status | Caloric Restriction | Physical activity | cancer treatment | Malignant neoplasm of skin | melanoma | Communicable Diseases | Acquired Immunodeficiency Syndrome | Active tuberculosis | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Cerebrovascular accident | Transient Ischemic Attack | Home oxygen supply | Chronic disease | Life Expectancy | Sodium, Dietary | Heart failure Midstage | Heart failure Late stage | Heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C2348568
UMLS CUI [3]
C1135809
UMLS CUI [4]
C0026606
UMLS CUI [5]
C0920425
UMLS CUI [6]
C0007114
UMLS CUI [7]
C0025202
UMLS CUI [8]
C0009450
UMLS CUI [9]
C0001175
UMLS CUI [10]
C0151332
UMLS CUI [11]
C1868885
UMLS CUI [12]
C0871470
UMLS CUI [13]
C0428883
UMLS CUI [14]
C0038454
UMLS CUI [15]
C0007787
UMLS CUI [16]
C0421203
UMLS CUI [17]
C0008679
UMLS CUI [18]
C0023671
UMLS CUI [19]
C0037570
UMLS CUI [20,1]
C0018801
UMLS CUI [20,2]
C0205086
UMLS CUI [21,1]
C0018801
UMLS CUI [21,2]
C1279941
UMLS CUI [22]
C0018801
because of the dietary requirements of a pregnant woman, and the nature of weight loss and gain with pregnancy, inclusion of pregnant women in the study would confound the study results. those who become pregnant during the study will be withdrawn from the study.
Beschrijving

Pregnancy Affecting research results | Dietary Requirements | Weight decreased | Weight Gain

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C1171332
UMLS CUI [3]
C1262477
UMLS CUI [4]
C0043094
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Similar models

Eligibility Chronic Kidney Disease NCT02266823

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Diagnosis-Related Groups | Diabetes Mellitus, Non-Insulin-Dependent | Glomerular Filtration Rate | Body mass index | Study Subject Participation Status | Clinical Trials | Weight decreased | Capable of moderate physical activity
Item
in order to be eligible for the study, the individual must be 40 years of age or older; have a drg code of t2dm, gfr of 15-89 ml/min/1.73m2 and a bmi >30 kg/m2. the participant's physician of record will have verified that his/her patient can safely participant in an intervention study that involves weight loss and a goal of 150 minutes/week of moderate physical activity (comparable to brisk walking).
boolean
C0001779 (UMLS CUI [1])
C0011928 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C0017654 (UMLS CUI [4])
C1305855 (UMLS CUI [5])
C2348568 (UMLS CUI [6])
C0008976 (UMLS CUI [7])
C1262477 (UMLS CUI [8])
C3853097 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Characteristics Following
Item
those with the following characteristics will be excluded by the investigators:
boolean
C0680251 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
Unable Informed Consent | Study Subject Participation Status Limited | hearing impairment | Able to speak English Language | Unable to read | Patient Monitoring Dietary intake Physical activity Body Weight | Blind Vision | Illiteracy | Unwilling Randomization | Pregnancy | Pregnancy, Planned | Postpartum Period | Breast Feeding | Weight decreased | Nursing Homes | CARE FACILITY PERSONAL CARE HOME PLACEMENT | Prisoners | Diet Uncontrolled
Item
1. unable or unwilling to provide informed consent; (2) unable to participate meaningfully in an intervention that involves group sessions (e.g., due to uncorrected hearing impairment, non-english-speaking); (3) unable to read or otherwise use an ipad to monitor dietary intake, physical activity, and weight (e.g., blind, illiterate); (4) unwilling to accept randomization assignment; (5) pregnant, or plans to become pregnant in the next 12 months, less than 3 months postpartum, or nursing or within 6 weeks of having completed nursing; (6) weight loss of > 10% in the past 6 months except for postpartum weight loss; and (7) individuals who are institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have no control over their diet).
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C1384666 (UMLS CUI [3])
C0564215 (UMLS CUI [4,1])
C0376245 (UMLS CUI [4,2])
C0586741 (UMLS CUI [5])
C0030695 (UMLS CUI [6,1])
C1286104 (UMLS CUI [6,2])
C0026606 (UMLS CUI [6,3])
C0005910 (UMLS CUI [6,4])
C0456909 (UMLS CUI [7])
C0020899 (UMLS CUI [8])
C0558080 (UMLS CUI [9,1])
C0034656 (UMLS CUI [9,2])
C0032961 (UMLS CUI [10])
C0032992 (UMLS CUI [11])
C0086839 (UMLS CUI [12])
C0006147 (UMLS CUI [13])
C1262477 (UMLS CUI [14])
C0028688 (UMLS CUI [15])
C0741959 (UMLS CUI [16])
C0033167 (UMLS CUI [17])
C0012155 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
Comorbidity | Study Subject Participation Status | Caloric Restriction | Physical activity | cancer treatment | Malignant neoplasm of skin | melanoma | Communicable Diseases | Acquired Immunodeficiency Syndrome | Active tuberculosis | Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Cerebrovascular accident | Transient Ischemic Attack | Home oxygen supply | Chronic disease | Life Expectancy | Sodium, Dietary | Heart failure Midstage | Heart failure Late stage | Heart failure
Item
will exclude from the study those with underlying diseases which would increase the risk of participating in an intervention involving caloric restriction and physical activity. such individuals would include those requiring treatment for cancer, exclusive of skin cancer other than melanoma, in the past 2 years; infectious diseases including untreated aids and active tuberculosis; uncontrolled hypertension of >190 mmhg sbp or >105 mmhg dbp despite treatment; stroke or tia in the past 6 months; conditions requiring the use of home oxygen; or other chronic disease or condition likely to limit life span to < 1 year. a recent institute of medicine report suggests that reducing dietary sodium below 1,840 mg/day in those with mid- to late-stage heart failure may increase adverse events or mortality. thus investigators will exclude those with heart failure.
boolean
C0009488 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C1135809 (UMLS CUI [3])
C0026606 (UMLS CUI [4])
C0920425 (UMLS CUI [5])
C0007114 (UMLS CUI [6])
C0025202 (UMLS CUI [7])
C0009450 (UMLS CUI [8])
C0001175 (UMLS CUI [9])
C0151332 (UMLS CUI [10])
C1868885 (UMLS CUI [11])
C0871470 (UMLS CUI [12])
C0428883 (UMLS CUI [13])
C0038454 (UMLS CUI [14])
C0007787 (UMLS CUI [15])
C0421203 (UMLS CUI [16])
C0008679 (UMLS CUI [17])
C0023671 (UMLS CUI [18])
C0037570 (UMLS CUI [19])
C0018801 (UMLS CUI [20,1])
C0205086 (UMLS CUI [20,2])
C0018801 (UMLS CUI [21,1])
C1279941 (UMLS CUI [21,2])
C0018801 (UMLS CUI [22])
Pregnancy Affecting research results | Dietary Requirements | Weight decreased | Weight Gain
Item
because of the dietary requirements of a pregnant woman, and the nature of weight loss and gain with pregnancy, inclusion of pregnant women in the study would confound the study results. those who become pregnant during the study will be withdrawn from the study.
boolean
C0032961 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C1171332 (UMLS CUI [2])
C1262477 (UMLS CUI [3])
C0043094 (UMLS CUI [4])
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