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. 2019 Dec 2;2019(12):CD004542. doi: 10.1002/14651858.CD004542.pub3

WICKD 2019.

Trial name or title Wellbeing intervention for chronic kidney disease (WICKD): a randomised controlled trial study protocol
Methods This is a 3‐arm, wait list, single‐blind randomised controlled trial testing the efficacy of the Stay Strong App in improving psychological distress, depressive symptoms, QoL and treatment adherence among Indigenous clients undergoing HD in Alice Springs and Darwin with follow‐up over two periods of 3 months (total of 6 months observation). The study compares the efficacy of MCP using the AIMhi Stay Strong App with two control groups (control app intervention and treatment as usual).
Participants Inclusion criteria

  • Aboriginal and/or Torres Strait Islander person and aged ≥18 years, currently receiving maintenance HD in Alice Springs or Darwin and having been receiving this treatment for more than 6 months


Exclusion criteria

  • < 18 years, guardianship order in place, or unable to give informed consent (e.g. cognitively or visually impaired)
Interventions Treatment group

  • Early treatment with motivational care planning (MCP) using the Stay Strong App (62 participants); participants received MCP at baseline


Control group 1

  • Contact control/delayed treatment with the Stay Strong App (62 participants); participants received MCP after 3 months


Control group 2

  • Treatment as usual/delayed treatment with the Stay Strong App (32 participants) (usual care)
Outcomes

  • Psychological distress

    • The Kessler Distress Scale (K10)

  • Depression

    • The adapted Patient Health Questionnaire (PHQ‐9)

  • QoL

    • The EuroQoL instrument (EQ‐5D)

      • Mobility

      • Self‐care

      • Usual activities

      • Pain and discomfort

      • Anxiety and depression

  • Adherence to dialysis treatment planning through file audit

  • Cost effectiveness

    • Costs of dialysis

    • Costs of inpatient hospitalisations

    • ED presentations

    • Estimation of outpatient health care use
Starting date February 2017
Contact information Kylie M. Dingwall; kylie.dingwall@menzies.edu.au
Notes Protocol. Setting: Alice Springs and Charles Darwin University, Australia. Trial registration number: ACTRN12617000249358

AKI ‐ acute kidney injury; BAI ‐ Beck Anxiety Inventory; BDI‐II ‐ Beck Depression Inventory‐II; CBT ‐ cognitive behaviour therapy; ESKD ‐ end‐stage kidney disease; HADS ‐ Hospital Anxiety and Depression Scale; HD ‐ haemodialysis; HRQoL ‐ health‐related quality of life; KDQOL ‐ Kidney Disease Quality of Life; PD ‐ peritoneal dialysis; PSQI ‐ Pittsburgh Sleep Quality Index; QoL ‐ quality of life