The overall objective is to assess efficacy of an e-care path with screening and treating psychological distress, to overcome psychological barriers and promote psychological facilitators for life style behavior change among patients with CKD. A…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameter is the difference in self-reported change from
baseline on psychological distress between patients in the intervention and
control condition at post-intervention and 3-month follow up.
Secondary outcome
Secondary outcomes comprise personal goal achievement, self-management,
self-efficacy, and mental and physical health-related quality of life.
Background summary
For patients with chronic kidney disease (CKD), the adoption and maintenance of
self-care and a healthy life style is crucial, as it can postpone disease
progress and prevent cardiovascular complications. Unfortunately, most patients
with CKD experience problems in changing life style habits. Barriers and
facilitators to adopt and maintain a healthy life style are often psychological
factors, which form risk and resilience factors that influence quality of life
and determine how patients cope with CKD and the extent to which they are able
to change their life style habits. Therefore, it is essential to identify those
barriers and facilitators and treat psychological distress. As patients vary
regarding psychological distress levels and related difficulties in changing
life style habits, a personalized approach is needed that identifies patients*
personal risk profiles for (non)adaptation to CKD and the life style changes it
requires. The current project proposes an open randomized controlled trial with
(1) the development of a web-based screening tool and an accompanying patient
profile chart to identify psychological distress and barriers and facilitators
for behavior change among patients with CKD, and (2) a randomized multicenter
study to evaluate the effectiveness of an e-care path to treat psychological
distress, overcome psychological barriers, and promote psychological
facilitators for behavior change among patients with CKD. The findings will be
translated into practical recommendations about implementing a new e-care path.
Study objective
The overall objective is to assess efficacy of an e-care path with screening
and treating psychological distress, to overcome psychological barriers and
promote psychological facilitators for life style behavior change among
patients with CKD. A secondary objective is to detect barriers and facilitating
factors among patients and health care professionals for successful nation-wide
implementation of the e-care path, resulting in a proposal for implementation
strategies.
Study design
The present study is an open randomized controlled trial, in which 120 CKD
patients are randomly assigned to either the control condition or intervention
condition. After the intervention two follow-up measurements (at 3 and 6 months
after the start of the intervention groups) will take place.
Intervention
All patients will fill out a web-based screening questionnaire. Patients who
fulfill the criteria of heightened psychological distress and related life
style problems will be randomized to either the control or the intervention
condition. Patients in the control group will receive a feedback form about the
results of the screening, and further receive regular care. Patients in the
intervention condition receive tailored online cognitive behavioral therapy
aimed to treat psychological distress, overcome psychological barriers, and
promote psychological facilitators for behavior change among patients with CKD,
with feedback from a psychologist, in a period of maximally 3 months.
Study burden and risks
There are no risks attached to the study and the participating CKD patients are
at least 18 years old and mentally competent. The only burden for participants
is a time investment. The total involvement in the study for each individual
participant will be 6 months*approximately 1-1.25 hour per measurement moment
(self-report and clinical measurements) for controls and several additional
hours per week during the 3-month intervention period for participants
receiving the intervention, tailored to their personal needs and wishes. All
participants will receive insight into a range of domains of their
psychological functioning. Based on former studies in different populations,
the effects on health and quality of life of participants in the intervention
condition*the condition with the greatest required time investment*are expected
to be high, 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
* Under medical treatment by an internist-nephrologist
* Chronic kidney disease with an eGFR 20-89 ml/min/1.73m2
* * 18 years of age
* Sufficient command of the Dutch language
* Able to give informed consent
* Access to a computer or tablet with internet
Exclusion criteria
* Rapidly progressive renal function loss (> 10% renal function loss over the
last year)
* An anticipated need for dialysis work-up within the time frame of the study
* Blood pressure < 95 mmHg systolic not responding to withdrawal of
antihypertensives
* Medical conditions which are likely to interfere with completion of the study
(such as progressive malignancy or other debilitating illness) at the
discretion of the nephrologist
* Renal transplantation <1 year ago
* Difficulties in (written) communication (e.g., due to analphabetism)
* Severe psychiatric comorbidity that interferes with the study protocol
* Ongoing psychological treatment elsewhere
* Pregnancy
Design
Recruitment
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 | NL62540.058.17 |
Other | NL7338 (NTR7555) |