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Multisystemic Engagement & Nephrology Based Educational Intervention: A Randomized Controlled Trial Protocol on the Kidney Team at Home-Study (KTAH-Study)


- candidate number9060
- NTR NumberNTR2730
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-feb-2011
- Secondary IDsNL34535.078.10 / MEC-2011-004; CCMO / METC Erasmus MC
- Public TitleMultisystemic Engagement & Nephrology Based Educational Intervention: A Randomized Controlled Trial Protocol on the Kidney Team at Home-Study (KTAH-Study)
- Scientific TitleMultisystemic Engagement & Nephrology: A randomized trial of a home-based educational intervention to reduce differences in health care access between European and non-European renal patients.
- ACRONYMKidney Team At Home
- hypothesisPrimary outcomes with respect to living donation are: Knowledge, risk perception, subjective norm, communication and intention to engage in a certain behavior (choosing living donation). These concepts will be measured among the patient as well as their family and friends. We expect that they will show increased scores on the post-measurements compared to the pre-measurements. Secondary outcomes are the number applications for donor evaluation, the number of evaluations for living donation and the number of live kidney transplants among patients who participated in the study. Three months after the intervention we will compare the groups on these measures.
- Healt Condition(s) or Problem(s) studiedRenal Replacement Therapies, End-stage Renal Disease
- Inclusion criteriaThe participants consist of kidney patients from the Rotterdam region who are new to the outpatient pre-transplantation clinic (incidence cases) or who are already on the EuroTransplant waiting list (prevalence cases).
- Exclusion criteriaWe will only include patients without a living donor and patients and family/friends who are 18 years or over.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2011
- planned closingdate1-mrt-2013
- Target number of participants160
- InterventionsPatients will receive the study information after their second consultation with the nephrologist at the outpatient pre-transplantation clinic. The intervention consists primarily of two sessions at the patient's home. The first session (familiarization session) will be planned after patients have given their consent to participate. This interview is held with the patient alone. During this first session, a sociogram of the social environment will be constructed in order to determine which family members and/or friends (invitees) will be invited to the educational session. The second session (educational session) consists a meeting at the patient's home. This time it is intended that the invitees are present at the patient's home. In this session topics about kidney disease and possible forms of treatment will be discussed. We grant our patients that this discussion will be held in a save ambiance. In order to realize a save communication environment we will work with the therapeutic framework of systemic therapy.
- Primary outcomeThe primary parameters of the intervention are derived from the ASE-Model. This model is based on the theory of Theory of Planned Behaviour (TPB) of Fishbein and Ajzen (19) and is supplemented by elements from the Social Cognitive Theory (SCT) of Bandura (20). The ASE-Model has a wide scientific acceptance and represents a theoretical framework for explaining behaviour by connecting attitude, social influence, self-efficacy, knowledge, skills (communication), and barriers and resources (risk perception) to intention and behaviour.
- Secondary outcomeSecondary outcomes are the number applications for donor evaluation, the number of evaluations for living donation and the number of live kidney transplants among patients who participated in the study.
- TimepointsAt start, 4 weeks later and 3 months later.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. S.Y. Ismail
- CONTACT for SCIENTIFIC QUERIESDrs. S.Y. Ismail
- Sponsor/Initiator Dutch Kidney Foundation (Nierstichting Nederland);
- Funding
(Source(s) of Monetary or Material Support)
Dutch Kidney Foundation (Nierstichting Nederland)
- PublicationsIsmail SY, Luchtenburg AE, Massey EK, Claassens L, Busschbach JJ, Weimar W. Living kidney donation among ethnic minorities: A Dutch qualitative study on attitudes, communication, knowledge and needs of kidney patients. http://repubeurnl/resource/pub_20862/indexhtml. 2010;8.
- Brief summaryWe found nearly all patients to be in favour of LDKT (96%). However, multiple prohibiting and interrelated factors played a role in considering LDKT. We propose a model which addresses these factors as barriers to LDKT in our non-European patients. These barriers are:
1. A perceived gap in information;
2. Cognitions and emotions;
3. Social interference;
4. Non-communication with family and friends.
Additionally, we found that our patients held a welcoming attitude towards tailored education program, for instance a home-based education.
- Main changes (audit trail)
- RECORD2-feb-2011 - 13-apr-2012


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