Development and evaluation of a psychosocial treatment to increase perceptions of control among patients who undergo dialysis

ISRCTN ISRCTN52734559
DOI https://doi.org/10.1186/ISRCTN52734559
Secondary identifying numbers 201500047
Submission date
23/07/2020
Registration date
23/10/2020
Last edited
16/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Ms Alicia M de Vries
Public

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone +31 (0)628687921
Email a.m.de.vries@umcg.nl

Study information

Study designMulticenter interventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleDevelopment and evaluation of a psychosocial intervention aimed at regaining perceptions of control among patients undergoing dialysis
Study objectivesParticipants 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(s)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
Health condition(s) or problem(s) studiedPatients with chronic kidney disease on dialysis
InterventionParticipants 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 typeBehavioural
Primary outcome measurePerceptions 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 measuresAssessed 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 study start date01/09/2014
Completion date31/08/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants67
Total final enrolment21
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment01/08/2015
Date of final enrolment31/08/2017

Locations

Countries of recruitment

  • Netherlands

Study participating centres

University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Martini Ziekenhuis
Van Swietenplein 1
Groningen
9728 NT
Netherlands
Scheper Ziekenhuis
Boermarkeweg 60
Emmen
7824 AA
Netherlands
Dialyse Centrum Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
Dianet
Brennerbaan 130
Utrecht
3524 BN
Netherlands

Sponsor information

University Medical Center Groningen
Hospital/treatment centre

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Phone +31 (0)50 361 4204
Email metc@umcg.nl
Website http://www.umcg.nl
ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Charity

Nierstichting
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Dutch Kidney Foundation
Location
Netherlands

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned 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 planThe 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).

Editorial Notes

05/10/2020: Trial's existence confirmed by University Medical Center Groningen Medical Ethical Committee.