- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04925635
Fistula Care and Mobile Health Applications in Hemodialysis Patients
The Effect of Fistula Care Training With Mobile Health Application on Hemodialysis Patients' Adaptation and Self-Care Behaviors
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Chronic renal failure is a clinical picture characterized by chronic, progressive deterioration in metabolic and endocrine functions, in adjusting the fluid-electrolyte balance of the kidney as a result of a decrease in glomerular filtration value. When the glomerular filtration value decreases to 5-10 ml/minute, end-stage renal failure develops. Renal replacement therapies such as hemodialysis, peritoneal dialysis and kidney transplantation are applied in patients diagnosed with end-stage renal disease. Renal replacement therapies are life-sparing treatments and the most common method applied is hemodialysis. The success of dialysis, which is a highly effective medical technology, in saving lives is indisputable. Arteriovenous fistula opened for hemodialysis is the lifeline of sick individuals, and hemodialysis is a critical treatment method based on the vascular access pathway. In this context, compliance with treatment is of vital importance in individuals with a diagnosis of end-stage renal disease, and lack of vascular access can reduce its efficiency in a short time. Studies show that only 25% of hemodialysis patients can take care of themselves.
The inadequacy of the individual's knowledge and behaviors of arteriovenous fistula care impairs adherence to treatment, reduces the effectiveness of the treatment and increases the cost. Interventions that encourage changes in health behavior and encourage individuals to change their lifestyle should be integrated into daily life, and there should be support for when and where individuals can make decisions that may affect their health. Mobile technologies, such as smart mobile phones, that individuals regularly carry, can be an effective platform for encouraging health behavior change, especially since they are likely to be with the individual when they need it.
In recent years, applications designed specifically to encourage physical activity in the field of mobile technology have gained momentum. As a result of the literature research, no examples of mobile health applications developed with educational content on fistula care, which hemodialysis-dependent patients can reach at any time and place, have not been found. Based on this, it was planned to increase the knowledge level of arteriovenous fistula care and examine their self-care behaviors and their adaptation to the disease with the mobile application developed with a focus on education on fistula care, which can be used independently by machine-dependent hemodialysis patients. In this context, it is aimed that dialysis patients will benefit especially in arteriovenous fistula care applications, thanks to the ever-increasing mobile applications in daily use with the developing technology. It is thought that the use of these technology-based trainings will be more comfortable, useful and encouraging for their own self-care. It is planned to be a guide for healthcare professionals.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Istanbul, Tacchino, 34660
- Saglik Bilimleri University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Over 18 years old,
- Literate (can understand and speak Turkish),
- Do not have a diagnosed mental and psychological disease,
- Hearing or visually impaired,
- Open to communication and cooperation,
- Having arteriovenous fistula,
- Having a smart phone,
- Individuals willing to participate in the research will be included.
Exclusion Criteria:
- Those with arteriovenous graft,
- Those with a catheter,
- Those receiving peritoneal dialysis.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
experimental group
The arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group.
|
The arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group.
Arteriovenous fistula care mobile health application will be installed in daytime groups during working hours during or at the end of dialysis according to the patient's request.
In addition, the information contained in the arteriovenous care mobile health application will be verbally explained to the patients and their relatives, as well as shown in practice.
The training results were evaluated by the researcher in the 1st and 3rd months in the "Scale for Evaluation of Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients", "Final Level of Renal Failure Compliance Scale", "Arteriovenous Fistula Care Education Knowledge Level Evaluation Form (Post-Training Section)" and " Visual Benchmarking Scale ".
|
control group
Patients in the control group will receive arteriovenous fistula care training and a training booklet will be given.
|
Patients in the control group will receive arteriovenous fistula care training and a training booklet will be given.
The information contained in the booklet will be explained orally to the patients and their relatives by the researcher, and will also be shown in practice.
The results of the training were determined by the researcher at the 1st and 3rd months of the "Self-Care Behaviors Scale for Arteriovenous Fistula in Hemodialysis Patients", "End Stage Renal Failure Compliance Scale", "Arteriovenous Fistula Care Training Information Level Assessment Form (Post-training section)" and "Visual It will be evaluated with the "Comparison Scale".
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
self-care behavior
Lasso di tempo: 5 month
|
Patients were informed about the Self-Care Behaviors Assessment Scale for Arteriovenous Fistula in Hemodialysis Patients.
(The scale consisting of 16 items in total; Each item is scored according to the statements opposite.
A minimum of 1 point indicates that the specified self-care behavior never develops, and the highest 5 points indicate that the specified self-care behavior always exists.
The minimum score that can be obtained from the scale is 16, and the maximum score is 80.As the score increases, it is evaluated that the person's self-care behaviors are positive.)
|
5 month
|
adaptation to illness
Lasso di tempo: 5 month
|
Patients were informed about the End Stage Renal Failure Compliance Scale.
(It consists of 5 chapters and 46 items.
The total score that can be obtained from the scale varies between 0 and 1200.
As the score obtained from the scale increases, the level of adherence to treatment increases.)
|
5 month
|
knowledge level
Lasso di tempo: 5 month
|
Patients were informed about the Arteriovenous Fistula Care Education Evaluation Form.
(It states that there is no "0 point" information when scoring the form, but "1 point" information.
The total score that can be obtained from the form varies between 0 and 13.
The higher the score, the higher the AVF care knowledge level.)
|
5 month
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Cevriye Ozdemir, Lecturer, Saglik Bilimleri University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- i060708c.A
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su mHealth
-
Chin-Tsung ShenCompletatoIntervento mHealthTaiwan
-
Mbarara University of Science and TechnologyCompletatomHealth | Salute materna | MultimediaUganda
-
Marie Stopes InternationalLondon School of Hygiene and Tropical MedicineCompletatoContraccezione | mHealth | Post-abortion Family PlanningCambogia
-
Society for Applied StudiesLondon School of Hygiene and Tropical MedicineCompletatomHealth per migliorare l'alimentazione complementareIndia
-
Health Services Academy, Islamabad, PakistanSconosciutomHealth | Riammissione | Comunicazione Teach BackPakistan
-
Ain Shams UniversityReclutamentomHealth | eHealth | Igiene oraleEgitto
-
AmendDartmouth-Hitchcock Medical CenterCompletatoIntervento mHealth | Prevenzione degli infortuni stradali | Uso del cascoTanzania
-
International Centre for Diarrhoeal Disease Research...University of Chicago; Marquette University; Mailman School of Public HealthReclutamentoInquinamento dell'aria | Funzione cardiopolmonare | Funzione immunitaria | Intervento mHealthBangladesh
-
Duke UniversityNew York University; National Institutes of Health (NIH); National Institute on...Non ancora reclutamentoAllenamento cognitivo | Salute cognitiva | Applicazione mHealth | Co-design basato sull'esperienza | EtnogeriatriaStati Uniti
-
University of CopenhagenMinistry of Health and Social Welfare, Zanzibar; Danish International Development...CompletatoGravidanza | mHealth | Salute materna | Comportamento sanitario | Morte neonataTanzania
Prove cliniche su experimental group
-
University of BurgundyCompletato
-
M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
-
Rush University Medical CenterCompletato
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
-
Kara MarlattCompletatoMenopausa | Condizioni correlate alla menopausaStati Uniti
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalCompletato
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNon ancora reclutamentoSiringomielia | Malformazione di ChiariFrancia
-
Apreo Health, Inc.ReclutamentoEnfisema o BPCOAustralia
-
Memorial Sloan Kettering Cancer CenterColumbia University; NYU Langone Health; Roswell Park Cancer Institute; Jacobi Medical... e altri collaboratoriReclutamentoMalati di cancroStati Uniti
-
University of TorontoCompletatoAllattamento al seno | Popolazione vulnerabile | Pompaggio del seno | Nutrizione infantileCanada