Group-based Chronic Kidney Disease Care
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New York
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Bronx, New York, Förenta staterna, 10461
- Albert Einstein College of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Inget ingripande: Usual Care
Participants who are randomized to usual care will see their provider on clinic days when there is no group meeting.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood pressure control
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Accelerometer
Tidsram: 6 months
|
Evaluate effects of group-based care on physical activity
|
6 months
|
|
Medication Adherence
Tidsram: 6 months
|
Measured by the Morisky 8-item Medication Adherence scale.
|
6 months
|
|
Quality of Life
Tidsram: 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)
Tidsram: 6 months
|
Evaluate patient and provider satisfaction
|
6 months
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2014-3117
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