Wellbeing intervention for chronic kidney disease (WICKD): a randomised controlled trial study protocol.
Attitude to Health
Australia
Culturally Competent Care
/ methods
Female
Health Promotion
/ methods
Health Services, Indigenous
Humans
Male
Motivation
Population Groups
Quality of Life
/ psychology
Renal Dialysis
/ psychology
Renal Insufficiency, Chronic
/ psychology
Research Design
Single-Blind Method
Telemedicine
/ methods
Treatment Adherence and Compliance
/ psychology
Treatment Outcome
E-mental health
Indigenous
Kidney disease
Renal
Wellbeing
Journal
BMC psychology
ISSN: 2050-7283
Titre abrégé: BMC Psychol
Pays: England
ID NLM: 101627676
Informations de publication
Date de publication:
08 Jan 2019
08 Jan 2019
Historique:
received:
15
08
2018
accepted:
23
10
2018
entrez:
10
1
2019
pubmed:
10
1
2019
medline:
28
2
2019
Statut:
epublish
Résumé
Incidence of end stage kidney disease (ESKD) for Indigenous Australians is especially high in remote and very remote areas of Australia (18 and 20 times the rate of comparable non-Indigenous people). Relocating away from family and country for treatment, adjusting to life with a chronic condition and time lost to dialysis cause grief and sadness which have immense impact on quality of life and challenges treatment adherence. We describe the first randomised controlled trial to address both chronic disease and mental health in Indigenous people with ESKD, which is the first to test the effectiveness of a culturally adapted e-mental health intervention in this population. It builds on an existing program of mental health research with demonstrated efficacy - the Aboriginal and Islander Mental Health Initiative (AIMhi) - to test the newly developed electronic motivational care planning (MCP) therapy - the AIMhi Stay Strong App. This is a 3-arm, waitlist, single-blind randomised controlled trial testing the efficacy of the Stay Strong App in improving psychological distress, depressive symptoms, quality of life and treatment adherence among Indigenous clients undergoing haemodialysis for ESKD 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) on participant-reported psychological distress (the primary outcome) using the Kessler Distress Scale (K10); depressive symptoms using the adapted Patient Health Questionnaire (PHQ-9); quality of life using the EuroQoL instrument (EQ5D) and adherence to dialysis treatment planning through file audit. Participants are randomised to receive MCP either at baseline (early treatment) or after 3 months (delayed treatment). The study also examines the cost effectiveness of this therapy in this setting through examination of health care service utilisation across groups during the first 3 months. This project will contribute much needed evidence on the efficacy of an electronic wellbeing intervention for Indigenous people with ESKD - a group in which distress is likely to be unacceptably high, yet relatively untreated. Australian New Zealand Clinical Trial Registry; ACTRN12617000249358 ; Date registered: 17/02/2017.
Sections du résumé
BACKGROUND
BACKGROUND
Incidence of end stage kidney disease (ESKD) for Indigenous Australians is especially high in remote and very remote areas of Australia (18 and 20 times the rate of comparable non-Indigenous people). Relocating away from family and country for treatment, adjusting to life with a chronic condition and time lost to dialysis cause grief and sadness which have immense impact on quality of life and challenges treatment adherence. We describe the first randomised controlled trial to address both chronic disease and mental health in Indigenous people with ESKD, which is the first to test the effectiveness of a culturally adapted e-mental health intervention in this population. It builds on an existing program of mental health research with demonstrated efficacy - the Aboriginal and Islander Mental Health Initiative (AIMhi) - to test the newly developed electronic motivational care planning (MCP) therapy - the AIMhi Stay Strong App.
METHODS
METHODS
This is a 3-arm, waitlist, single-blind randomised controlled trial testing the efficacy of the Stay Strong App in improving psychological distress, depressive symptoms, quality of life and treatment adherence among Indigenous clients undergoing haemodialysis for ESKD 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) on participant-reported psychological distress (the primary outcome) using the Kessler Distress Scale (K10); depressive symptoms using the adapted Patient Health Questionnaire (PHQ-9); quality of life using the EuroQoL instrument (EQ5D) and adherence to dialysis treatment planning through file audit. Participants are randomised to receive MCP either at baseline (early treatment) or after 3 months (delayed treatment). The study also examines the cost effectiveness of this therapy in this setting through examination of health care service utilisation across groups during the first 3 months.
DISCUSSION
CONCLUSIONS
This project will contribute much needed evidence on the efficacy of an electronic wellbeing intervention for Indigenous people with ESKD - a group in which distress is likely to be unacceptably high, yet relatively untreated.
TRIAL REGISTRATION
BACKGROUND
Australian New Zealand Clinical Trial Registry; ACTRN12617000249358 ; Date registered: 17/02/2017.
Identifiants
pubmed: 30621791
doi: 10.1186/s40359-018-0264-x
pii: 10.1186/s40359-018-0264-x
pmc: PMC6325814
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2Subventions
Organisme : National Health and Medical Research Council
ID : 1098311
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