Fatigue in Chronic Haemodialysis Patients: an Experience Sampling Method Study

Články mohou překládat pouze registrovaní uživatelé

Přihlášení Registrace

Odkaz je uložen do schránky

PostaveníDokončeno

Sponzoři

Zuyderland Medisch Centrum

Spolupracovníci

Maastricht University

KLINICKÉ HODNOCENÍ: NCT04049773

BioSeek: nct04049773

Klíčová slova

Abstraktní

To investigate the course and diurnal change of fatigue symptoms and haemodialysis related symptoms in chronic haemodialysis patients, its relation to haemodialysis treatment and the association with other factors by implementing an ecological momentary assessment procedure incorporated in a webapplication.

Popis

The course and diurnal change of fatigue symptoms in the daily life of chronic haemodialysis (HD) patients, its relation to haemodialysis treatment and the association with other factors such as mood, activities, location and social context will be evaluated during 7 consecutive days by using an ecological momentary assessment (EMA) procedure, incorporated into a webapplication. Using an EMA procedure will more accurately represent fatigue symptoms and its relation to other factors in the daily life of chronic HD patients compared to conventional measurement instruments (i.e. questionnaires evaluating fatigue over a period of a week or more, which are therefore liable to a recall bias).

Termíny

Poslední ověření:	06/30/2019
První předloženo:	08/01/2019
Odhadovaná registrace vložena:	08/06/2019
První zveřejnění:	08/07/2019
Poslední aktualizace byla odeslána:	01/30/2020
Poslední aktualizace zveřejněna:	02/04/2020
Aktuální datum zahájení studie:	07/14/2019
Odhadované datum dokončení primární:	08/21/2019
Odhadované datum dokončení studie:	12/30/2019

Stav nebo nemoc

Fatigue

End Stage Renal Disease

Intervence / léčba

Procedure: haemodialysis

Fáze

Kritéria způsobilosti

Věky způsobilé ke studiu	18 Years Na 18 Years
Pohlaví způsobilá ke studiu	All
Metoda vzorkování	Non-Probability Sample
Přijímá zdravé dobrovolníky	Ano
Kritéria	Inclusion Criteria: - End stage renal disease requiring chronic haemodialysis treatment currently being treated for at least 6 months. - Good understanding of Dutch based on clinical judgment (since the web-application is only available in the Dutch language). Exclusion Criteria: - The participant cannot independently handle the web-application based on clinical judgment. - Dementia or insufficient cognitive skills to handle the web-application based on clinical judgement by the attending physician.

Výsledek

Primární výsledná opatření

1. Change in fatigue symptoms throughout the day [7 consecutive days]

self-reported fatigue intensity on a 7-point Likert scale (from 1 "not fatigued" to 7 "very fatigued") at ten occasions randomly throughout the day.

Měření sekundárních výsledků

1. Change in fatigue symptoms (primary outcome) and its association with mood [7 consecutive days]

Questions with respect to mood are evaluated on a 7-point Likert scale (from 1 '"not at all" to 7"very much").

2. Change in fatigue symptoms (primary outcome) and its association with location, activities and social context [7 consecutive days]

Location, social context and activities related questions are provided in a multiple-choice format.

3. Change in haemodialysis related symptoms (such as muscle cramps, itch, bone pain, headache) throughout the day [7 consecutive days]

Self-reported intensity of the above-mentioned symptoms on a 7-point Likert scale (from 1 "not at all" to 7 "very much") at ten occasions randomly throughout the day.