The effectiveness of tailored E-health self-management treatment for patients with end-stage renal disease: A randomized controlled trial

Recruiting

• Conditions: End-stage renal disease (ESRD); Kidney Disease; 10038430

• Registration Number: NL-OMON50543
• Lead Sponsor: niversiteit Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

* End-stage renal disease (GFR <15 ml/min/1.73 m2)
* Treated for at least 3 months by means of dialysis (hemodialysis or
peritoneal dialysis)
* * 18 years of age
* Sufficient command of the Dutch language

Exclusion Criteria

* Serious medical conditions that are likely to interfere with completion of
the study (such as progressive malignancy or other debilitating illness) at the
discretion of the nephrologist
* A life expectancy < 12 months at the start of the study
* A planned kidney transplant within 12 months
* Serious psychological comorbidity interfering with the study protocol (i.e.,
diagnosis according to the Diagnostic and Statistical Manual of Mental
Disorders (DSM))
* Recent serious stressful life event unrelated to the ESRD
* Serious cognitive problems disabling participation in the self-management
treatment
* Current psychological treatment
* No access to a computer and internet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>As primary outcome measure, the effects of the treatment on distress will be<br /><br>examined. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>As secondary outcome measures, the effectiveness of the treatment on 4 domains<br /><br>will be examined:<br /><br>1. change in disease-specific self-efficacy and self-management<br /><br>2. changes in relevant aspects of functioning related to the treatment modules<br /><br>(e.g., coping with fatigue, pain, itch, negative mood and social functioning)<br /><br>3. meaningful improvements on the areas of interest to the patients (using a<br /><br>personalized outcome measure)<br /><br>4. cost-effectiveness of the treatment (the profits of the intervention in<br /><br>terms of health care use and societal participation as compared to the extra<br /><br>costs of the treatment in addition to care as usual</p><br>