Tsay 2004.
Methods |
Study design: RCT Unit of randomisation: patient Unit of analysis: patient Funding sources: National Science Council of Taiwan Conflicting interests: not stated |
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Participants |
Country: Taiwan Setting: Dialysis centres in 2 hospitals Conditions/numbers: 50 patients with end‐stage renal disease (ESRD) (25 intervention, 25 control) Multi‐morbidity: n/a Health literacy: n/a |
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Interventions |
Theoretical framework: n/a Focus: patient Type of intervention: Structured, face‐to‐face self‐management support Clinicians involved: Nurse (additional) Tools: The programme focused on helping participants develop skills and self awareness in goal‐setting, problem‐solving, stress management, coping, social support and motivation. It included participant identification of problem areas for self management of ESRD, the exploration of emotions associated with these problems, the development of a set of goals and strategies to overcome these problems and for achieving the goals, making a behavioural change plan, and initiating self‐care behaviours and stress management. Participants received an information package + individual consulting sessions 3 times a week for 4 weeks (p. 61). Stages completed: Limited ‐ B, C, F Usual provider aware of patient's goals and action plans: Not stated Standardisation of clinician input: Strong ‐ single clinical nurse specialist provided coaching (p. 61) Fidelity: not reported Attrition: no drop‐outs Comparison: Information package + usual care |
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Outcomes |
Health status:psychological: Beck Depression Inventory Self‐management capabilities: Empowerment scale, Strategies used by People to Promote Health (SUPPH) Health behaviours: n/a Achievement of personal goals: n/a Service use: n/a Adverse events: none reported Length of follow‐up: baseline, 6 weeks |
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Notes | No primary outcome. Power calculation performed and number of participants reported as adequate but few details provided. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were assigned to experimental or control group based on SPSS statistical randomisation software (p. 60) |
Allocation concealment (selection bias) | Unclear risk | Researcher and nurse were aware of which treatments participants were receiving, but data collector was not. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants' usual caregivers (physicians, nurses, dieticians, and/or social workers) were uninformed about treatment group (p. 61), but not possible to blind participants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The data collector was a trained research assistant who was unaware of the participant's status to maintain double‐blind accuracy. (p. 61) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐outs in either group. |
Selective reporting (reporting bias) | Unclear risk | No published protocol. Results reported for all outcome measures. |
Other bias | Low risk |