- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01245517
The Influence of Dietary Phosphorus Education Program on Nutritional Status and Serum Phosphate Level Among Hemodialysis Patient
Aim:
Dietary Phosphorus Education Program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients.
Inclusion criteria:
The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0 mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion.
Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects. Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions.
Intervention protocol:
At baseline, the investigators collect demography and pre-test KAP questionnaires among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview and record their answers. Dietary Phosphorus Education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly.
The first month was intensive weekly education sessions, each 20 to 30 minutes. Second and third month were monthly education sessions, each 20 to 30 minutes. There are total 6 sessions in this trial. The last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. If subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. Investigator collect post-test KAP questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. If subjects are illiterate then investigators interview subjects and record.
This is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Shwu-Huey Yang, PhD
- Numéro de téléphone: 6568 886-2-27361661
- E-mail: sherry@tmu.edu.tw
Lieux d'étude
-
-
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Taipei, Taïwan
- Recrutement
- Taipei Medical University - WanFang Hospital
-
Contact:
- Shwu-Huey Yang
- Numéro de téléphone: 6568 886-2-27361661
- E-mail: sherry@tmu.edu.tw
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. Subjects' age range is from 20 to 85 years old. Their baseline serum albumin < 4.0 mg/dL, or serum phosphate > 5.0 mg/dL, are eligible for inclusion. Subjects will be enrolled into this trial after signed informed consent. We expect to recruit 60 subjects
Exclusion Criteria:
- Patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly.
- We will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Dietary Phosphorus Education Program
|
Dietary Phosphorus Education Program
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
The difference of biochemistry values including phosphate, calcium-phosphate product, albumin, etc.
Délai: first month
|
first month
|
The difference of knowledge, attitude and practice (KAP) questionnaire's scores during the study program.
Délai: third month
|
third month
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
To estimate subjects' protein and calorie intake according to 3-day dietary records.
Délai: sixth month
|
sixth month
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Shwu-Huey Yang, Taipei Medical University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 99053
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