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The effectiveness of a psychological intervention to improve treatment adherence and quality of life in dialysis patients

The effectiveness of a self-management intervention to improve outcomes in prevalent haemodialysis patients: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31434033
Enrollment
156
Registered
2010-09-22
Start date
2010-08-20
Completion date
Unknown
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

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 Kidn

Sponsors

National Kidney Foundation (Singapore)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026