Plain English Summary
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys don't work as well as they should. Perceiving that one has little control over one’s life is a frequently reported problem among people with CKD who are on dialysis, and it has been shown to be related to lower well-being and quality of life. This study aims to develop a psychosocial intervention for enhancing perceptions of control in people on dialysis and evaluate its effectiveness.
Who can participate?
Patients undergoing dialysis (hemodialysis or peritoneal dialysis) in a center or at home, aged 18 or older, reporting low perceived control
What does the study involve?
Participants are randomly allocated to either the intervention group or the waiting list control group. Participants in the intervention group receive the psychosocial intervention directly. Participants in the waiting list control group receive the intervention after the waiting period. The intervention includes four sessions of 45-60 minutes, every week or every other week and 1 follow-up session after 1 month, administered by medical social workers of the dialysis units or the responsible researcher (with a Master's degree in clinical psychology). The intervention is administered at a location and time most suitable to dialysis patients. Perceptions of control are assessed with a questionnaire before and after the start of the intervention in the intervention group, or with a time-interval of 4-6 weeks in the waiting list control group.
What are the possible benefits and risks of participating?
The possible benefits are that the intervention could potentially enhance perceptions of control in participants and therefore increase feelings of well-being. There are no expected risks associated with participation, apart from the time and effort people invest in their participation.
Where is the study run from?
University Medical Center in Groningen (Netherlands)
When is the study starting and how long is it expected to run for?
September 2014 to August 2017
Who is funding the study?
Dutch Kidney Foundation (Netherlands)
Who is the main contact?
1. Alicia M. de Vries
a.m.de.vries@umcg.nl
2. Dr Maya J. Schroevers
m.j.schroevers@umcg.nl
Trial website
Contact information
Type
Public
Primary contact
Ms Alicia M de Vries
ORCID ID
Contact details
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)628687921
a.m.de.vries@umcg.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
201500047
Study information
Scientific title
Development and evaluation of a psychosocial intervention aimed at regaining perceptions of control among patients undergoing dialysis
Acronym
Study hypothesis
Participants in the intervention condition will show more pronounced improvements in perceived control and measures of well-being compared to participants in the waitinglist control condition.
Ethics approval
Approved 24/02/2015, University Medical Center Groningen Medical Ethical Committee (Medisch Ethische Toetsingscommissie UMCG, HPC LA15, POB 30001, 9700 RB Groningen, Netherlands; +31 (0)50 361 4204; metc@umcg.nl), ref: METc 2014/321
Study design
Multicenter interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Patients with chronic kidney disease on dialysis
Intervention
Participants are randomized to either the intervention condition or waiting list control condition via randomization software with a 1:1 ratio. Given the nature of the study, participants cannot be blinded with regard to condition allocation.
Intervention: self-regulation psychosocial intervention aimed at increasing perceptions of control in dialysis patients. The intervention includes four sessions of 45-60 minutes, every week or every other week and 1 follow-up session after 1 month, administered by medical social workers of the dialysis units or the responsible researcher (with a Master's degree in clinical psychology). The intervention is administered at a location and time most suitable to dialysis patients.
Participants in the waiting list control condition are offered the psychosocial intervention after the waiting list period.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Perceptions of control, assessed with the self-report Mastery Questionnaire before and after the start of the intervention in the intervention condition, or with a time-interval of 4-6 weeks in the waiting list control condition.
Secondary outcome measures
Assessed with self-report questionnaires:
1. Depression measured with the Patient Health Questionnaire (PHQ-9)
2. Anxiety measured with the Generalized Anxiety Disorder Questionnaire (GAD-7)
3. Well-being measured with the World Health Organization - Five Well-being index (WHO-5).
Assessments took place before and after the start of the intervention in the intervention condition, or with a time-interval of 4-6 weeks for the waiting list control condition.
Overall trial start date
01/09/2014
Overall trial end date
31/08/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Receiving dialysis treatment (at the hospital or at home)
3. Having low perceived control as indicated by a score of 23 or below on the Mastery scale (Pearlin & Schooler, 1978)
4. Sufficient knowledge of the Dutch language
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
67
Total final enrolment
21
Participant exclusion criteria
1. Unable to speak/write/read Dutch
2. Severe psychiatric comorbidity
3. Receiving a psychological treatment
4. Recent start or unstable pharmacological treatment (e.g. antidepressants, anxiolytics)
Recruitment start date
01/08/2015
Recruitment end date
31/08/2017
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Trial participating centre
Martini Ziekenhuis
Van Swietenplein 1
Groningen
9728 NT
Netherlands
Trial participating centre
Scheper Ziekenhuis
Boermarkeweg 60
Emmen
7824 AA
Netherlands
Trial participating centre
Dialyse Centrum Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Trial participating centre
Dianet
Brennerbaan 130
Utrecht
3524 BN
Netherlands
Sponsor information
Organisation
University Medical Center Groningen
Sponsor details
Hanzeplein 1
Groningen
9713 GZ
Netherlands
+31 (0)50 361 4204
metc@umcg.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Nierstichting
Alternative name(s)
Dutch Kidney Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Netherlands
Results and Publications
Publication and dissemination plan
Planned publications:
1. Screening study on reasons why dialysis patients do not accept care to regain control in the context of a randomized controlled trial.
2. Study on the effectiveness, feasibility and acceptability of a psychosocial intervention for regaining perceptions of control in patients with chronic kidney disease receiving dialysis: a randomized controlled trial.
The study protocol is available upon request.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Maya J. Schroevers (m.j.schroevers@umcg.nl).
Intention to publish date
01/01/2021
Participant level data
Available on request
Basic results (scientific)
Publication list