- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00583570
Phosphorus Improvement Pilot Study
31. marts 2009 opdateret af: MetroHealth Medical Center
Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The amount of phosphorus in the American diet has increased considerably, primarily from phosphorus-containing additives in convenience and ready to eat foods (Calvo 1996).
It is estimated that, depending on individual food choices, additives add as much 1000 mg/day of phosphorus to the diet (Bell).
Phosphorus in additives is almost entirely absorbed while only 60% of naturally occurring phosphorus is absorbed (Uribarri 2003).
Education regarding high phosphorus foods is a key component of hyperphosphatemia management (Ford 2004, Cupisti 2004), but the use of phosphorus additives may make it difficult for patients and dietitians to estimate phosphorus content of foods.
It has been suggested that hyperphosphatemia is a nutritional barrier to preventing renal bone disease and that an intervention focusing on phosphate containing food additives has great potential (Sherman).
Our objective is to determine the effect of an educational intervention regarding phosphate additives on serum phosphorus about 300 chronic hemodialysis patients at Centers for Dialysis Care (CDC) and Fresenius Medical Care (FMC) in Cuyahoga County.
Facilities will be randomized to intervention and control groups.
All dietitians and eligible patients at the intervention facilities will be invited to take part in the intervention.
All dietitians and consenting eligible patients at control facilities will form a usual care group.
Prior to the trial, demographic and medical characteristics, lab data and medications will be collected for the previous three months using a chart abstraction and patient interview form.
Demographic characteristics include age, sex, race, education and insurance status.
Medical characteristics include dialysis dose, binder prescription, vitamin D dosing, cause of renal failure, number of months on dialysis, and major co-morbid conditions.
Lab data will include albumin, calcium, phosphorus, serum bicarbonate, and PTH.
Medication data will include binder prescription and bone medications.
In the first month of the trial study coordinators will meet with intervention and control subjects and assess basic knowledge regarding phosphorus content of foods and label reading.
Intervention subjects will also receive education regarding phosphorus additives and their effect on the phosphorus content of foods, a laminated card listing common phosphorus additives, and a handout about additives in foods from fast food restaurants where they eat.
The subject will be instructed to use the materials when shopping or eating out to avoid phosphorous additives.
During the 2nd month of the trial, study coordinators will contact intervention subjects by phone to reinforce educational materials and answer questions.
Control subjects will be contacted and asked about shopping and eating habits.
During the 3rd month the interviews from month 1 will be repeated for both intervention and control subjects to assess changes in knowledge.
Intervention subjects will also be asked to evaluate the phosphorus additives tool and provide feedback for evaluating the ease of use and utility.
Having a control group that receives attention but not the key intervention (phosphorus containing additives education and tools) will allow us to distinguish the effect of attention from the effect of the intervention.
Chart abstraction data on labs, dialysis dose, binder prescription, and vitamin D dosing will be collected for all three months of the trial.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
279
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Most recent phosphorus and mean phosphorus over last 3 months > 5.5 mg/dL
- Age ≥ 18 years
- On chronic hemodialysis ≥ 6 months
- English speaking
Exclusion Criteria:
- Mentally incompetent
- AIDS
- Cancer
- Terminal illness
- Pregnancy
- Nursing home residence
- No telephone access
- In another phosphorus related study
- Unable to identify written words
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: EN
|
dietary education
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.
Tidsramme: 3 months
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ashwini Sehgal, MD, MetroHealth Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2007
Primær færdiggørelse (Faktiske)
1. februar 2008
Studieafslutning (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først indsendt
20. december 2007
Først indsendt, der opfyldte QC-kriterier
20. december 2007
Først opslået (Skøn)
31. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. april 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. marts 2009
Sidst verificeret
1. marts 2009
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB06-01323
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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