- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02467894
Group-based Chronic Kidney Disease Care
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This two-group RCT will enroll 100 subjects, adolescents over or equal to 12 years of age, and men and women over age of 21, with stage 3-4 and 5 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology. The primary aim will be to assess feasibility of the intervention.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and 24 hr urine test will be collected to assess for sodium, phosphorus, and serum creatinine. These tests will be used for experimental purposes only and will be collected at enrollment and 6 months visit.
There will be two arms, an arm randomized to Group-based care attending monthly outpatient clinic visits as part of a group and the other to usual care who will see their provider once a month for 6 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
Bronx, New York, Forenede Stater, 10461
- Albert Einstein College of Medicine
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adolescent Age ≥12 years old
- Sufficient hearing, vision, and proficiency in English or Spanish to comprehend low- literacy printed educational materials and participate in group sessions (assessed by provider)
- Adult: (¬>21 years): Systolic blood pressure >140 at two clinic visits in the past year or >160 at one visit and Adolescent: (12-21 years) systolic blood pressure >95 percentile (based on sex and age) at 2 clinic visits in the past year
- For adults: Stage 3-5 CKD (eGFR<60 ml/min/1.73m2)
- For adolescents: evidence of kidney damage (albuminuria, congenital anomalies of the kidney or urinary tract) and hypertension
- Prescription for anti-hypertensive medication (in adults)
- Unwillingness to accept random assignment
- Unwillingness to provide informed consent
Exclusion Criteria:
- Transplanted organ
- Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months
- Plans to relocate out of New York City in the next 6 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Group-based Care
Participants who are randomized to group-based care will attend monthly outpatient clinic visits as part of a group of 8-10 patients with CKD and hypertension.
|
There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
|
Ingen indgriben: Usual Care
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Blood pressure control
Tidsramme: 6 months
|
The primary outcome will be blood pressure control (mean SBP <140 mmHg) as measured by 24-hour ambulatory blood pressure monitor.
|
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Accelerometer
Tidsramme: 6 months
|
Evaluate effects of group-based care on physical activity
|
6 months
|
Medication Adherence
Tidsramme: 6 months
|
Measured by the Morisky 8-item Medication Adherence scale.
|
6 months
|
Quality of Life
Tidsramme: 6 months
|
We will collect quality of life measurements using the Peds QL in the adolescent group and the SF-36 in the adult sample.
We want to evaluate whether group-based care may lead to improved or worse reported quality of life in participants.
|
6 months
|
Health Resources and Services Administration (HRSA)
Tidsramme: 6 months
|
Evaluate patient and provider satisfaction
|
6 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2014-3117
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