Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000810516
Ethics application status
Approved
Date submitted
12/09/2014
Date registered
5/08/2015
Date last updated
5/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of a psychological intervention to reduce the severe stress and psychological morbidity of people with chronic kidney disease who are commencing maintenance dialysis: The Dialysis Optimal Health Program.
Scientific title
Evaluating the impact of a psychological intervention to reduce the severe stress and psychological morbidity of people with chronic kidney disease who are commencing maintenance dialysis: The Dialysis Optimal Health Program.
Secondary ID [1] 285327 0
Nil
Universal Trial Number (UTN)
U1111-1161-6917
Trial acronym
DOHP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 293049 0
anxiety 293050 0
depression 293051 0
chronic kidney disease 295502 0
end stage kidney disease 295503 0
Condition category
Condition code
Mental Health 293324 293324 0 0
Depression
Mental Health 293325 293325 0 0
Anxiety
Renal and Urogenital 295762 295762 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Optimal Health program (OHP) is a collaborative therapy and selfefficacy intervention. The program is delivered to participants in a modular format over 8 sequential weeks followed by a booster at 3mths. It is delivered via telephone or face to face over 1hr by trained program assistants (Honours degree in psychology students from collaborating partner universities). Strategies used to monitor adherence to the intervention include participant use of a manual; and the requirement for program assistants to record file notes
1. The Optimal Health program (OHP) utilises a modular format. Each module encompasses a manualised discrete skill development intervention run over 8 weeks (plus booster session) involving: health promotion, interagency collaboration, accessible support care coordinator, understanding stress, family and community support. The modular format allows for tailoring of the intervention to suit the needs of adults with end stage renal failure (ESRF) transitioning to dialysis. Similarity across modules in terms of the core intervention, plus overlap between modules, enhances implementation through familiarity with the methods and style. This also addresses efficiency and cost-effectiveness with respect to training staff. Each session is designed to build on the learnings from the previous session with the ‘I Can Do model’ as the core theme.
2. Rural patients are offered the program over the phone. The program is delivered 1 session per week for 8 sequential weeks.
3. The booster session at 3 months is one hour duration and the overall theme for this session is to address 'what is my health like now' for participants. This booster session will involve review of progress and reflection on achievements towards health-related goals.
Intervention code [1] 290239 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 293151 0
Composite depression and anxiety as assessed by the: Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 293151 0
baseline (prior to intervention), 3, 6 and 12 months post-intervention
Secondary outcome [1] 310461 0
Quality of life as assessed by the Kidney Disease Quality of Life scale (KDQoL)
Timepoint [1] 310461 0
baseline (prior to intervention), 3, 6 and 12 months post-intervention
Secondary outcome [2] 315868 0
Self efficacy as assessed by the General Self-efficacy Scale (GES)
Timepoint [2] 315868 0
baseline (prior to intervention), 3, 6 and 12 months post-intervention e
Secondary outcome [3] 315870 0
Illness perceptions as assessed by the Brief Illness Perception Questionnaire (brief-IPQ)
Timepoint [3] 315870 0
baseline (prior to intervention), 3, 6 and 12 months post-intervention
Secondary outcome [4] 315871 0
Coping strategies as assessed by an abbreviated version of the COPE inventory (Brief-Cope)
Timepoint [4] 315871 0
baseline (prior to intervention), 3, 6 and 12 months post-intervention

Eligibility
Key inclusion criteria
1. Patients with End Stage Kidney Disease (ESKD) who are expected to commence maintenance dialysis for the first time within the next three months or who have commenced dialysis in the past three months. 2. Age 18 years or above. 3. Able to converse in English without an interpreter. 4. Currently under the management of the Nephrology team at St. Vincent’s Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if there is presence of developmental disability or amnestic syndrome impairing their ability to learn from the intervention or if they are returning to dialysis following a failed renal transplant.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be generated using random numbers and subjects in each arm of the study will be stratified for mode of dialysis (peritoneal dialysis or haemodialysis), and randomised progressively as patients are consented and complete baseline assessment. Central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using random numbers and subjects in each arm of the study will be stratified for mode of dialysis (peritoneal dialysis or haemodialysis), and randomised progressively as patients are consented and complete baseline assessment. Central randomization by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/10/2014
Actual
30/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2979 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 8692 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 289946 0
Government body
Name [1] 289946 0
Collaborative Research Network
Department of education
Country [1] 289946 0
Australia
Primary sponsor type
Government body
Name
Department of Education GPO Box 9880 Canberra ACT 2601
Address
Department of Education
GPO Box 9880
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 288636 0
University
Name [1] 288636 0
Australian Catholic University
Address [1] 288636 0
115 Victoria Parade Fitzroy Victoria 3065
Country [1] 288636 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291662 0
ST. VINCENT’S HOSPITAL (MELBOURNE)
Ethics committee address [1] 291662 0
Ethics committee country [1] 291662 0
Australia
Date submitted for ethics approval [1] 291662 0
Approval date [1] 291662 0
30/06/2014
Ethics approval number [1] 291662 0
019/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51410 0
A/Prof Robyn Langham
Address 51410 0
St Vincent's Hospital Victoria Pde Fitzroy, Vic 3065
Country 51410 0
Australia
Phone 51410 0
+61 3 9231 2211
Fax 51410 0
Email 51410 0
[email protected]
Contact person for public queries
Name 51411 0
Emmet O'Flaherty
Address 51411 0
St Vincent's Hospital Victoria Pde Fitzroy, Vic 3065
Country 51411 0
Australia
Phone 51411 0
+61 3 9231 3196
Fax 51411 0
Email 51411 0
[email protected]
Contact person for scientific queries
Name 51412 0
Robyn Langham
Address 51412 0
St Vincent's Hospital Victoria Pde Fitzroy, Vic 3065
Country 51412 0
Australia
Phone 51412 0
+61 3 9231 2211
Fax 51412 0
Email 51412 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDesign and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1558-z
EmbaseA psychosocial intervention for individuals with advanced chronic kidney disease: A feasibility randomized controlled trial.2021https://dx.doi.org/10.1111/nep.13850
N.B. These documents automatically identified may not have been verified by the study sponsor.