Condition category
Urological and Genital Diseases
Date applied
30/07/2010
Date assigned
22/09/2010
Last edited
04/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Konstadina Griva

ORCID ID

Contact details

Department of Psychology
Faculty of Arts and Social Sciences
National University of Singapore
Block AS4 #02-28
9 arts link
Singapore
117570
Singapore

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.
Our 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 approved on the 19th of December 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

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

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

Department of Psychology
Singapore
117570
Singapore

Sponsor information

Organisation

National Kidney Foundation (Singapore)

Sponsor details

NKF Research Committee
c/o Clinical Affairs
Level 3
81 Kim Keat Road
Singapore
328836
Singapore

Sponsor type

Charity

Website

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

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21272382

Publication citations

  1. 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.

Additional files

Editorial Notes