Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NKFRC2008/07/24
Study information
Scientific title
The effectiveness of a self-management intervention to improve outcomes in prevalent haemodialysis patients: a randomised controlled trial
Acronym
Study hypothesis
This study will use self management principles to improve clinical and psychological outcomes through enabling patients to better follow their treatment regimes.
The overall aim of this randomised controlled trial is to evaluate the effectiveness of a self management intervention delivered in group to established haemodialysis patients (i.e. at least 6 months on haemodialysis). Effectiveness of the group based self management intervention will be established by assessing clinical outcomes, biological markers of adherence and psychosocial functioning in established haemodialysis patients compared to a control group receiving standard care.
The primary hypothesis is that participation in the self management program will lead to better psychosocial wellbeing, greater adherence to treatment recommendations and improved clinical markers in established haemodialysis patients compared to standard care.
Ethics approval
The National University of Singapore Institutional Review Board, 19/12/2008, ref: NUS IRB 08-151
Study design
Single-blind cluster randomised controlled trial with randomisation at dialysis shift level
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Chronic kidney disease; end stage renal disease; haemodialysis
Intervention
The study will recruit prevalent haemodialysis patients and will randomise them to one of two groups:
1. Standard Care Care currently received by patients as defined by National Kidney Foundation Clinical Practice Guidelines. All healthcare resources used and advice given to prevalent patients relating to their kidney failure and its treatment will be standardised.
2. Intervention Group based self management intervention will take place over a 6 week period with one 120 minute session every two weeks, facilitated by a psychologist, dietician and nurse. Patients are required to implement the coping-strategies taught from each session between sessions. Each session will be broadly structured to consist of a brief introduction to the theme to be covered in the session, elicitation of patients views on the topic, addressing of misconceptions, group discussion of possible coping strategies, identification of barriers to change, training in specific management strategies, drawing up of individual goals to be achieved, formulating actions plans to achieve these goals and reviewing previously set goals.
Healthcare professionals working in National Kidney Foundation, Singapore will be trained in self management techniques to facilitate the sessions and provide participants with the knowledge and skills to improve their management.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
These will be obtained by reviewing participants medical records during the study period.
1. Adherence to medication and dietary restrictions, as indicated by attendance for dialysis, blood phosphate, calcium x phosphate and potassium levels and gain between dialysis sessions. Data will be obtained from patients medical records throughout the study window. Baseline values will be compared to follow-up values immediately post- intervention and at 3 and 9 months post- intervention.
2. Blood pressure control
3. Baseline values will be compared to follow up values immediately post- intervention and at 3 and 9 months post- intervention
4. Hospitalisation rates
5. Dialysis attendance (skipping and shortening behaviours)
6. The Charlson Comorbidity Index and The End Stage Renal Disease Severity Index (ESRD-SI) will be used to measure co-morbid illnesses and other complications of end stage renal disease
7. Medical notes will be also reviewed and relevant information regarding dialysis history and dialysis related events (e.g. access complications) during the study period
Secondary outcome measures
1. Quality of Life measured using the Kidney Disease Quality of Life Short Form (KDQoL-SF) and the World Health Organisation Quality of Life Assessment-Bref (WHOQOL-Bref)
2. Mood as measured by the Hospital Anxiety and Depression Scale (HADS) Self efficacy Scores using the Self Efficacy for Managing Chronic Disease Scale
3. Treatment and medication beliefs as measured by The Renal Adherence Attitudes Questionnaire and the Beliefs about medication questionnaire
4. Health Education measured using the Health Education Impact Questionnaire (HEIQ)
5. Self-reported adherence to dietary and fluid restrictions using the Renal Adherence Questionnaire and a 12 item self report adherence scale developed for the purposes of the study
All questionnaire measures will be taken at patients enrolment into the study (baseline), 1 week after completion of self management program and at 3 and 9 months post- intervention.
Overall trial start date
20/08/2010
Overall trial end date
30/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Chronic Kidney Disease patients (either sex) who have been receiving haemodialysis for at least 6 months
2. Aged 21 and over
3. Patients willing to attend all sessions of the self management programme
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A target sample of 152 haemodialysis patients [n = 76 intervention group; n = 76 standard care control group].
Participant exclusion criteria
1 Newly established on haemodialysis (< 6 months)
2. Unable to give informed consent
3. Unable to understand spoken English and/or Mandarin, Malay, Tamil dialects to allow effective communication with the intervention facilitator(s)
4. A diagnosis of functional psychosis or organic brain disorder
5. Impaired cognition
6. Major visual or hearing impairments, or other sensory or motor impairments that may prohibit completion of the scheduled assessments
7. Unable to participate in a group program (e.g. housebound)
8. Limited life expectancy due to comorbid illness such as malignancy
Recruitment start date
20/08/2010
Recruitment end date
30/12/2012
Locations
Countries of recruitment
Singapore
Trial participating centre
National University of Singapore
Singapore
117570
Singapore
Funders
Funder type
Research organisation
Funder name
National Kidney Foundation (Singapore) - Venerable Yen Pei - National Kidney Foundation Research Fund (ref: NKFRC2008/07/24)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21272382
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29198641
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30190046 (added 11/10/2019)
Publication citations
-
Protocol
Griva K, Mooppil N, Seet P, Krishnan DS, James H, Newman SP, The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients., BMC Nephrol, 2011, 12, 4, doi: 10.1186/1471-2369-12-4.