The objective of the study is threefold: 1) to examine the psychosocial well-being of partners after patients have undergone RT, as a function of gender of the partner and medical characteristics of the patient. 2) to examine interpersonal factors…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study aims at gaining insight into psychosocial well-being of partners of
patients who have undergone renal transplantation, in terms of affect and
marital satisfaction, and at gaining insight into dyadic processes of
well-being and medical adjustment over time.
Secondary outcome
N.v.t.
Background summary
Dealing with the consequences of end-stage renal disease (ESRD) as well as
renal transplantation (RT) is a challenging task. Both do not only impact
patients, but also their social environment, most notably their partners, and
dealing with the disease can be seen as a joint effort of the couple. However,
research concerning psychosocial well-being of partners and dyadic coping with
ESRD and RT is scarce. This study aims to fill this gap by examining the
emotional well-being of partners and the couple during the phase of ESRD, while
patients are on a waiting list for RT, and after RT. In addition, we propose to
examine the role of interpersonal variables in psychosocial well-being of both
patients and partners. Attention will also be paid to the role of these factors
in patients* adherence to medical regimen and dietary and exercise
recommendations after RT.
Study objective
The objective of the study is threefold:
1) to examine the psychosocial well-being of partners after patients have
undergone RT, as a function of gender
of the partner and medical characteristics of the patient.
2) to examine interpersonal factors that are associated with psychosocial
well-being in patients as well as
their partners and patients* adherence to medical regimen, dietary and
exercise recommendations after RT.
3) to investigate the psychosocial well-being and adjustment of couples during
the phase of end-stage renal
disease (ESRD), while patients are on a waiting list, and after RT.
Study design
The proposed study is part of an ongoing project designed to examine the short-
and long-term impact of end stage renal disease (ESRD) and renal
transplantation (RT) on quality of life of patients. In this ongoing project
the goal is to gain insight into factors that predict adherence to medical
regimen, as well as compliance with dietary and exercise recommendations of
patients during the first year after transplantation. The current study is
aimed at the partners of patients that have undergone transplantation and
consists of a cross-sectional and a prospective part. Partners will be
contacted along with the patients in the ART-study at the set time points.
In the patient cohort study of the ART-project, patients who had undergone
renal transplantation in the UMCG during the past fifteen years filled out a
questionnaire assessing their quality of life and several psychosocial
variables. For the current cross-sectional study, an invitation card for the
partners was already sent together with the patient questionnaires. Also,
partners already sent back the permission forms allowing the researchers to
contact them for further information about the study. After giving informed
consent for participation, a self-report questionnaire will also be sent to
these partners by mail by the research team.
In the prospective part of the ART-project, the following patients will be
included: patients who are currently on the waiting list for transplantation at
one assessment point before transplantation and then again at three, six,
twelve and twenty-four months after transplantation. For the proposed
prospective part of the partner study, the same procedure as for the
cross-sectional part will be followed. First, an invitation form will be send
together with the patient questionnaires. After getting permission, the
informed consent form and the partner questionnaire will be send as well.
Study burden and risks
For the cross-sectional study, partners of the patients who underwent RT will
be approached for participation. This will be done as follows: patients in the
ART-study (nr. 800616), who were invited also received information about the
current partner study to be shared with their partners. Partners who were
interested could return an invitation card indicating their permission to be
contacted by the research team. Partners who returned the invitation card will
be sent an information letter and an informed consent form. After giving
informed consent for participation, a self-report questionnaire will be sent to
the partners by the research team. This procedure will be followed in the
prospective study as well.
The questionnaire will take approximately one hour to complete. Assessed are
psychosocial well-being and several interpersonal factors, such as
communication patterns with the couple and provided support. No adverse events
should be expected from participation.
A. Deusinglaan 1
9700 AD Groningen
NL
A. Deusinglaan 1
9700 AD Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients who have undergone renal transplantation at the UMCG during the past 15 years and their partners will be included in the study. Patients and partners have to be at least 18 years of age at the first assessment. The study is open to both men and women and all ethnic groups as long as participants are in command of the Dutch language.
Exclusion criteria
As blind patients and partners will not be able to read the questionnaires, they will be excluded.
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 |
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CCMO | NL25903.042.08 |