We plan to develop and introduce a personalized multi component care program aimed at prevention or postponement of progressive deterioration of kidney functioning. Recently, a medical dashboard (a *Shared Care Record* to which all kidney patients…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is reduction in renal function deterioration. Renal
function will be determined using iohexol measurement. Iohexol will be injected
in the vene of the patient according to the routine clinical protocol,
subsequently blood drawing will take place at (3 or 4) preset time points.
Concentrations will be measured using HPLC technique at the laboratory. Using
the blood concentrations in a pre-developed limited sampling model, an area
under the concentration time curve will be determined. Subsequently the GFR is
calculated. This procedure is performed at study start and study end. The GFR
decline will then be calculated based on these two measurement for all
patients.
Secondary outcome
Compliance:
Improved compliance (frequency of missing a dose (>4 hours after pre-set time),
monitored using electronic medication blisters. Original Advagraf blisters will
be repacked and provided with a layer consisting of an electronic circuit
including microchip. This chip monitors the amount and time of Advagraf
capsules being extracted from the blister. Compliance will be defined as the
percentage of correct dose intakes.
In addition, the Basel Assessment of Adherence to Immunosuppressive Medications
Scale (BAASIS, De Geest, 2005) will be completed at 3 points in time (baseline,
12 and 24 months).
DBS / AUC*s:
- Variation in AUC
- Frequency of adjusting the dose
- Feasibility DBS (patient experience / Logistics)
- Addendum 17-06-2019: next to the regular DBS Hemaxis kit, patients will also
receive the DBS Mitra Neoteryx kit at the endpoint of the RRFD study in order
to calculate the AUC for tacrolimus. The DBS Mitra Neoteryx seems easier to
handle, more specifically for patients with reduced vision ability.
Clinical:
- Other biomarkers renal function / kidney damage
- Proteinuria (via alb/creat or protein/creat ratio)
- Blood pressure measurements / number anti-hypertensive drugs => blood
pressure measurements (at home/hospital) / Dynamap: 3 times 15 min in chair)
- BMI (Weight hospital) / Waist-hip ratio
Immunological:
- DSA (blood withdrawal)
- Immunological biomarkers (yet to define)
Diabetes / cardiovascular:
- Glucose tolerance test
- HbA1c => incidence / regulation diabetes (blood withdrawal)
- (cholesterol / HDL / LDL/Triglycerides)
- Pulse Wave Velocity => cardiovascular
- Cardiovascular events (cerebral / cardiac / peripheral)
Lifestyle:
- Nutritional pattern: sodium, saturated fat, purine-rich, fructose (via
questionnaires, 24 hours-urine (sodium, urea) and nutrition module medical
dashboard (only intervention group)
- activities (through questionnaire) and motion detector (optional).
Psychological:
- Satisfaction (Renal Treatment Satisfaction Questionnaire)
- Transplant related psychological parameters (worry about loss of transplant,
feeling of guilt regarding donor, Transplant Effects Questionnaire)
- Generic assessment scale for chronic condition self-management (PiH, Partners
in Health Scale: Petkov et al., 2010
- Personal beliefs about kidney disease and medicine intake (IPQ-short form:
Broadbent et al., 2006; Beliefs about Medicines Questionnaire: Horne et al.,
1999(18))
- Short questionnaire on current health status (EQ5D);
- Quality of life (SF-12)
- Life style behaviours (i.e., sodium intake, smoking habits, alcohol intake,
level of physical exercise)
- A set of new Likert scale questions and open questions about patients*
specific concerns and desires, and self-efficacy regarding self-management and
at home monitoring.
- A small set of new Likert scale to assess expectations and actual experiences
regarding the intervention programme.
Process-evaluation
- Experience healthcare professionals and patients) at study end
- Logging => Number of self-measurements (Blood pressure, weight)
- Feasibility DBS implementation at home
- Number of medication interventions regarding immunosuppressive medication
- Percentage of AUC*s outside of the target range?
Other parameters
- Calcium, phosphate, PTH, vit D => Bone parameters
- Haemoglobin => cardiovascular risk
- Uric acid => risk of gout
Background summary
Over the last decades, novel immunosuppressive drug regimen have significantly
reduced the incidence of acute graft rejection episodes after kidney
transplantation. However, long-term graft survival has not improved
concomitantly [1]. Optimal survival of the transplanted kidney depends on a
number of factors; the donor and transplant procedure characteristics such as
living versus deceased donor, cold ischemic time, donor age, HLA matching as
well as co-morbidities of the recipient and optimal immunosuppressive therapy
[2*5]. Immunosuppressive agents have a small therapeutic window and have often
highly variable pharmacokinetics which makes therapeutic drug monitoring (TDM)
of immunosuppressive drug concentrations essential for individualizing the
dose and thereby preventing serious toxicity or rejection [6*9]. Furthermore
suboptimal use of immunosuppressive medication and incompliance plays a central
role in the shortened long-term graft survival in renal transplantation [10].
The main causes of late graft loss are death with graft function (dominated by
cardiovascular disease) and chronic allograft dysfunction (dominated by a
complex interplay between immunological and non-immunological causes). The key
of new technological and scientific developments is to enhance personalized
treatment regimens in order to meet each patient*s specific health needs.
Study objective
We plan to develop and introduce a personalized multi component care program
aimed at prevention or postponement of progressive deterioration of kidney
functioning. Recently, a medical dashboard (a *Shared Care Record* to which
all kidney patients and their treating physician(s) have access) was
implemented in our regular outpatient care, including: 1. laboratory results,
2.results of self-monitoring by the patient regarding blood pressure, body
weight and 3. e-coaching to optimize communication between patients and
doctors. Using the medical dashboard is expected to increase patients* active
participation in their care. In addition to the general medical dashboard, we
plan to offer study participants the following:
* Improving (both intentional and non-intentional) compliance of patients by
(a) improvement of knowledge and skills of the patient, (b) improving
motivation, (c) offering practical tools, and (d) improving communication
skills of involved health care practitioners
* Medication review by outpatient pharmacy
* Use of Dried Blood Spot Technology for at-home based eAUC-monitoring (to
obtain optimal immunosuppressive drug exposure)
* Option of participation in a life-style program (exercise / nutrition)
* Additional medical dashboard features, being a personal care plan addressing
personal goals and concerns regarding compliance and optional e-modules that
support patients in adopting and maintaining a healthy life-style.
Study design
Single center implementation study.
Intervention
There are 3 interventions:
1. Interventions to help improve compliance
2. At home monitoring of immunosuppressive drugs
3. Lifestyle program (optional)
1. Monitoring of immunosuppressive drugs via Dried Blood Spot technique
(tacrolimus)
2. Improvement of compliance (stepwise additional effect of different tools):
- App with medication alarm
- Medication review
- Feedback when medication is administered four ours too late (through
Electronic blistering).
3. Lifestyle modules (optional) with/without support, focused on nutrition and
physical exercise.
Study burden and risks
In addition to regular care (potential burden)
- completing questionnaires at baseline, 12 and 24 months
- pulse wave velocity measurement at baseline and 24 months
- use of Dried Blood Spot technique to sample blood at home to determine drug
exposure (AUC) (3 additional measurements compared to regular care)
- one visit to a lifesteyle coach at baseline (remainder is facultative)
- two medication reviews with a hospital pharmacist
Risks
Participation within the trial comes with minimal risks (if present). At home
monitoring of tacrolimus blood concentration via fingerprick can result in some
discomfort. Venapunctures at the hospital could eventually result in hematoma.
Addendum 17-06-2019: at the endpoint of the RRFD study the only extra
intervention will be the use of DBS Mitra Neoteryx kit, in order to calculate
the AUC of tacrolimus. As described in section E4: the DBS Mitra Neoteryx kit
will be handed out to patients in the RRFD study who agree to participate in
the side project of this study, meaning a total of 25 patients (from the
original N=100 RRFD study group).
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- > 1 year after kidney transplantation
- Follow-up visits take place in LUMC
- Creatinine clearance (CKD-EPI > 25 ml/min)
- Immunosuppressive regimen based on tacrolimus
- Sufficient mastery of Dutch
- Access to and capacity to use the internet.
- Availability of a Smart-phone (necessary for blistering)
- Informed consent
Exclusion criteria
- No internet access
- Creatinine clearance (CKD-EPI * 25 ml/min)
- Insufficient knowledge of Dutch language
- Proven allergy for iodine contrast
Design
Recruitment
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 | NL58000.058.16 |
| OMON | NL-OMON20914 |