ID

38979

Description

Behavioral Activation Therapy for Both Depression and Diabetes Vs. Diabetes Alone Delivered Via Group Visits; ODM derived from: https://clinicaltrials.gov/show/NCT02027259

Link

https://clinicaltrials.gov/show/NCT02027259

Keywords

Versions (1)
  1. 11/17/19 11/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT02027259

English

Eligibility Diabetes NCT02027259

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02027259
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of type 2 diabetes
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011860
clinical diagnosis of depression
Description

Depressive disorder

Data type

boolean

Alias
UMLS CUI [1]
C0011581
phq-9 score ≥10 for depressive symptoms
Description

PHQ-9 Depressive Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C4083201
UMLS CUI [1,2]
C0086132
>= 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
a most recent hba1c ≥8.0% within the previous 12 months in the chart; and
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
have 1 or more of the following modifiable cvd risk factors not at target goals, defined as:
Description

Cardiovascular Disease Risk factors Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1265611
current smoker (any cigarette smoking <30 days),
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
blood pressure >130/80 mm hg, documented at least twice in the last 6 months
Description

Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0005824
ldl cholesterol >100 mg/dl within the last 12 months.
Description

Serum LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to attend the group sessions
Description

Participation Group session Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C0679644
UMLS CUI [1,4]
C1299582
active psychosis of any type or organic brain injury that precludes dm self- care
Description

Psychotic Disorder | Brain Injury | Diabetes Mellitus Self-care Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0033975
UMLS CUI [2]
C0270611
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C3872897
UMLS CUI [3,3]
C0332196
type 1 diabetes as documented in the medical chart
Description

Diabetes Mellitus, Insulin-Dependent

Data type

boolean

Alias
UMLS CUI [1]
C0011854
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
actively suicidal and /or
Description

Suicidal

Data type

boolean

Alias
UMLS CUI [1]
C0438696
end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant)
Description

Terminal illness | Neoplasm Metastasis | Awaiting organ transplant

Data type

boolean

Alias
UMLS CUI [1]
C0679247
UMLS CUI [2]
C0027627
UMLS CUI [3]
C2231107
patients currently enrolled in dm group programs that include medication titration within the group setting would not be eligible due to co- intervention.
Description

Enrollment Diabetes Mellitus Group Programs | Pharmaceutical Preparation Titration

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0011849
UMLS CUI [1,3]
C0441833
UMLS CUI [1,4]
C3484370
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0162621
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Similar models

Eligibility Diabetes NCT02027259

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT02027259
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent
Item
clinical diagnosis of type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Depressive disorder
Item
clinical diagnosis of depression
boolean
C0011581 (UMLS CUI [1])
PHQ-9 Depressive Symptoms
Item
phq-9 score ≥10 for depressive symptoms
boolean
C4083201 (UMLS CUI [1,1])
C0086132 (UMLS CUI [1,2])
Age
Item
>= 18 years old
boolean
C0001779 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
a most recent hba1c ≥8.0% within the previous 12 months in the chart; and
boolean
C0474680 (UMLS CUI [1])
Cardiovascular Disease Risk factors Quantity
Item
have 1 or more of the following modifiable cvd risk factors not at target goals, defined as:
boolean
C0007222 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Tobacco use
Item
current smoker (any cigarette smoking <30 days),
boolean
C0543414 (UMLS CUI [1])
Blood pressure determination
Item
blood pressure >130/80 mm hg, documented at least twice in the last 6 months
boolean
C0005824 (UMLS CUI [1])
Serum LDL cholesterol measurement
Item
ldl cholesterol >100 mg/dl within the last 12 months.
boolean
C0428474 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Participation Group session Unable
Item
inability to attend the group sessions
boolean
C0679823 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C0679644 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Psychotic Disorder | Brain Injury | Diabetes Mellitus Self-care Excluded
Item
active psychosis of any type or organic brain injury that precludes dm self- care
boolean
C0033975 (UMLS CUI [1])
C0270611 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C3872897 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes as documented in the medical chart
boolean
C0011854 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Suicidal
Item
actively suicidal and /or
boolean
C0438696 (UMLS CUI [1])
Terminal illness | Neoplasm Metastasis | Awaiting organ transplant
Item
end-stage medical illness (e.g. metastatic cancer, awaiting organ transplant)
boolean
C0679247 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C2231107 (UMLS CUI [3])
Enrollment Diabetes Mellitus Group Programs | Pharmaceutical Preparation Titration
Item
patients currently enrolled in dm group programs that include medication titration within the group setting would not be eligible due to co- intervention.
boolean
C1516879 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
C0441833 (UMLS CUI [1,3])
C3484370 (UMLS CUI [1,4])
C0013227 (UMLS CUI [2,1])
C0162621 (UMLS CUI [2,2])
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