To develop a workable and effective programma to encourage the self management abilities of people with progressive chronic kidney disease stage 1-4. The evaluation consists of a process- and an effect evaluation.The process evaluation will evaluateā¦
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the process evaluation is primarily aimed at the
workability and the feasibility of the STERK program. The content and the
structure of the training will be evaluated at the level of the patient and the
professional.
The effect evaluation will focus on the extent in which the training affects
self management abilities, perceptions of illness and treatment, self efficacy,
proactive competences and quality of life of patients.
Secondary outcome
The secundary outcomes of the study are glomerular filtration rate (GFR),
proteinuria blood pressure, Body Mass Index, salt intake, protein intake.
Background summary
Patients with chronic kidney disease can slow down or stop the decline of their
kidney function. To be motivated to take an active role in slowing down or
stopping the progression of their disease, patients need to become more capable
self managers of their illness. The STERK-program consists of a handbook and a
training that can help patients to increase their self management abilities and
quality of life.
Study objective
To develop a workable and effective programma to encourage the self management
abilities of people with progressive chronic kidney disease stage 1-4.
The evaluation consists of a process- and an effect evaluation.
The process evaluation will evaluate:
1. the experience of patients who participated in the STERK-program;
2. the willingness of patients to participate in the program;
3. the experience of health carers providers with the STERK-program (a.o.
approaching the study population, workability of the training) and
organisations (workload, logistics) and the encouraging and discouraging
factors that may interfere with working with this program.
The effect evaluation will evaluate:
1. the extent to which the program has contributed to improved self management
abilities, better perception of illness and treatment, more self-efficacy,
pro-active coping competence and an increased level of physical en mental
quality of life of patients.
2. the extent to which the training has contributed to improved clinical
outcomes (glomerular filtration rate (GFR), proteinuria
blood pressure, Body Mass Index, salt intake, protein intake, HbA1C).
3. the extent to which patients characteristics influence the effect of the
training on the self management abilities of patients, distinguishing
sociodemographic and illness-related characteristis, quality of life, illness
perceptions, self-efficacy and pro-active coping.
Study design
The study involves a multicenter randomised controlled trial design with a
control group. Patients who want to participate will be randomised into two
groups. Both groups will be asked to fill in a baseline questionnaire (T0),
after which Group 1 will receive the STERK-training and Group 2 the care as
usual. Both goups will be asked to fill in the next questionnaire (T1). Three
and six months after T1 patients will be asked again to fill in questionnaires
(T2 en T3).
Intervention
The intervention consists of four meetings lasting two hours in an eighty to
twelve weeks period and a meeting three months afterwards.
The meetings are interactive and consist of what it is like to have a kidney
disease, the treatment of their disease and the lifestyle factors that may
affect the progression of the kidney disease. Meetings consist of activities to
provide patients skills to become a self manager and so, where necessary and
advisable, prevent or delay progression of their kidney function.
The Common sense model of self-regulation (Leventhal, et al., 1984), the Theory
of pro-active coping (Aspinwall & Taylor, 1997), the Social cognitive theory
(Bandura, 1994) and the Transtheoretical model (Prochaska & DiClemente, 1984)
have been used as theoretical frameworks during the development of the
intervention.
Study burden and risks
Not applicable.
Groot Hertoginnelaan 34
1405 EE Bussum
NL
Groot Hertoginnelaan 34
1405 EE Bussum
NL
Listed location countries
Age
Inclusion criteria
Newly diagnosed patients
Patients with progressive chronic kidney disease
18 years of age and older
Exclusion criteria
Non-Dutch spreaking
Not allowed to give informed consent
Mental or cognitive problems
Not able to participate in groups
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37599.042.11 |