The primary objective is the evaluation of the newly developed ehealth intervention, as regards to the feasibility and satisfaction of donors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
nierdonoren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameters are the feasibility and satisfaction about the newly
developed eheatlh intervention.
Secondary outcome
Not applicable
Background summary
Living donor kidney transplantation is the preferred treatment for patients
with end-stage renal disease because of better long-term recipient and graft
survival than after transplantation with deceased donor kidneys. Furthermore,
the availability of a living donor kidney allows planning the transplantation
before dialysis treatment becomes necessary. Combined with the shortage of
organs from deceased donors, these advantages have led to a strong increase in
the number of living donor kidney transplantations in recent years. For
example, in the Netherlands, 51% of all kidney transplantations in 2012 was
performed with kidneys from living donors compared with 27% in 1996. Donors
have been found to have a high quality of life before donation, even better
than that of the general population, which is probably due to the stringent
medical screening for kidney donor eligibility. However, after donation about
5-25% of donors experience problems in physical or psychosocial functioning,
such as depressed mood, fatigue, or pain. For example, by feeling more
depressed after donation, or perceiving the surgery and recovery period as
stressful, or worrying about surgical complications, recipients* health, their
own health, or their work situation after donation. Currently, no
evidence-based interventions for living kidney donors at risk are available.
Preliminary research indicates that ehealth cognitive-behavioral interventions
are about as effective as face-to-face contact for a broad range of
psychological problems, such as anxiety and depression. The applicability of
ehealth interventions for patients with chronic somatic conditions have also
been examined, and a recent meta-analytic review found that guided ehealth
cognitive-behavioral interventions appears to be an effective treatment for
chronic somatic conditions to improve psychological and physical functioning
and disease-related impact. Based on evidence-based interventions for patients
with chronic somatic conditions, a ehealth intervention for (potential) donors
at risk was developed. Focus group interviews with living kidney donors and
healthcare professionals were conducted to explore donation-related themes
which could be implemented in the intervention.
In the present study, the ehealth intervention will be evaluated by a small
group of donors. This intervention is applicable during various stages of the
living kidney donation procedure, before donation as well as after donation.
Study objective
The primary objective is the evaluation of the newly developed ehealth
intervention, as regards to the feasibility and satisfaction of donors.
Study design
The present study is a pilot intervention study of a small group of (potential)
living kidney donors.
Procedure:
Inform
All potential donors who have contacted the hospital for a possible kidney
donation and have found to be suitable as kidney donors will be invited to
participate in the pilot study, by an information letter.
Screening
Patients who are willing to participate will receive specific information about
the screening and a questionnaire to assess potential risk factors for
longer-term adaptational problems. Patients will be informed about the results
of the questionnaire assessment by mail. Donors who can possibly take advantage
of the ehealth treatment receive further information about the
cognitive-behavioral intervention, together with an application form.
The intervention: ehealth treatment
Every patient who possibly could take advantage of the ehealth treatment, and
who is willing to participate will receive ehealth care with tailored
cognitive-behavioral therapy during several weeks.
Evaluation:
After finishing the ehealth treatment, donors will be asked to fill in the
evaluation questionnaire.
Intervention
First, one face-to-face consult with the therapist takes place, for
acquaintance and to explore treatment goals of the donor. Then tailored
cognitive-behavioral therapy will be offered through ehealth, consisting of
about eight sessions. One or two out of four possible treatment modules will be
offered during the treatment, depending on the risk profile of the donors. The
treatment modules are: coping with problems in social relationships, negative
mood, fatigue, (temporary) physical disability and pain, and consists about
patient education and practical assignments. At least once a week donors will
receive feedback from their therapist about the assignments, by means of a mail
box. Treatment will be conducted by a therapist who is specifically trained in
the tailored cognitive-behavioral protocol.
Study burden and risks
For the participating donors, there are no risks connected to the study. We
only ask donors to invest some of their time.
Wassenaarseweg 52
Leiden 2333 AK
NL
Wassenaarseweg 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
medically and psychosocially suitable potential donors or living donors who recently donated, above 18 years old, fluent in Dutch language.
Exclusion criteria
severe psychiatric comorbidity that interferes with the treatment protocol, ongoing psychological treatment elsewhere, pregnancy.
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 | NL50145.091.14 |