The overall aim is to assess the effectiveness of guided E-health self-management treatment that is tailored to the individual patient in patients with end-stage renal disease treated by dialysis.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As primary outcome measure, the effects of the treatment on distress will be
examined.
Secondary outcome
As secondary outcome measures, the effectiveness of the treatment on 4 domains
will be examined:
1. change in disease-specific self-efficacy and self-management
2. changes in relevant aspects of functioning related to the treatment modules
(e.g., coping with fatigue, pain, itch, negative mood and social functioning)
3. meaningful improvements on the areas of interest to the patients (using a
personalized outcome measure)
4. cost-effectiveness of the treatment (the profits of the intervention in
terms of health care use and societal participation as compared to the extra
costs of the treatment in addition to care as usual
Background summary
End-stage renal disease (ESRD) and renal replacement therapy (e.g. dialysis)
have a large impact on all areas of daily life of the patient. Many patients
can adjust well to these circumstances, but approximately 30 percent shows
adjustment problems. Because of the wide variety of problems that patients with
ESRD face, healthcare professionals are also confronted with the difficulty to
acknowledge the most prominent problems of individual patients. Moreover, there
are currently hardly any psychosocial treatments available for this group,
particularly no treatments that are tailored to the individual problems and
needs of the patients. E-health strategies offer a great opportunity to
optimize detection of adjustment problems and to tailor psychosocial care
specifically to these problems. The current project proposes a randomized
controlled trial to evaluate for the first time the effectiveness of guided
E-health self-management treatment for ESRD patients on dialysis that is
tailored to the individual patient needs. It is expected that the E-health
self-management treatment results in a lower impact of the disease on daily
life in comparison to care as usual, meaningful improvements on the areas of
interest to the patients, and lower costs.
Study objective
The overall aim is to assess the effectiveness of guided E-health
self-management treatment that is tailored to the individual patient in
patients with end-stage renal disease treated by dialysis.
Study design
A randomized controlled trial consisting of two conditions: the intervention
condition and the control condition. All patients will be screened on various
aspects of quality of life, after which those patients with adjustment problems
will be randomly assigned to one of the two conditions. Participants in the
intervention condition will receive a 3- to 4-month intervention. Patients in
the control condition will receive care as usual. Assessments will be performed
at baseline and 6 (post-treatment) and 12 months (6 months post-treatment)
after baseline.
Intervention
The E-health self-management treatment is based on evidence-based
cognitive-behavioral principles and aims to reduce the impact of the disease on
daily life, by optimizing how a patient copes with the condition (e.g.,
problem-focused coping skills) and improving physical and mental functioning
(e.g., decreasing fatigue and depressed mood). Patients will have a
face-to-face intake session with a therapist (the E-coach). The most important
goals to work on during the treatment will be determined during the intake
session(s). The treatment consists of an online self-management tool that is
guided by the E-coach, which is based on an effective face-to-face treatment
and has previously shown to be effective in improving quality of life in
patients with other chronic somatic conditions. The E-coach provides online
assignments, feedback and support tailored to the individual patient. The
treatment incorporates modules on the most relevant areas of daily life in ESRD
patients, aimed at coping with the impact of the disease on daily life,
including fatigue, disabilities, dependence upon other people, and depressed
mood. Patients will have an end-of-treatment consultation with their E-coach by
phone at the end of the study.
Study burden and risks
There are no risks attached to the study and the participating ESRD patients
are at least 18 years old and mentally competent. The only burden for
participants is a time investment. The total duration of the study for each
individual participant will be 12 months, but the extent of the burden will be
different for the two conditions. Patients in the control condition will only
have to fill out questionnaires at three time points (baseline and 6 and 12
months later), whereas patients in the intervention condition in addition to
filing out questionnaires will participate in a 3- to 4-month intervention.
Patients in the intervention condition will, depending on the effectiveness of
the treatment, potentially experience positive results regarding the impact of
the disease on their daily life. Based on former studies, these effects are
expected to be in proportion to the time investment burden.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63422.058.17 |
| Other | Trial NL7160 (NTR7359) |
| OMON | NL-OMON20743 |