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Trial registered on ANZCTR


Registration number
ACTRN12618000066280
Ethics application status
Approved
Date submitted
3/01/2018
Date registered
17/01/2018
Date last updated
17/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pre-post trial of a person-centred, theory-based intervention to support self-management in chronic kidney disease.
Scientific title
The CKD-SMS study: A pre-post trial of a person-centred, theory based intervention to support self-efficacy to manage disease in people with stage 1-4 chronic kidney disease.
Secondary ID [1] 293708 0
None.
Universal Trial Number (UTN)
U1111-1206-9111
Trial acronym
CKD-SMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 306056 0
Condition category
Condition code
Renal and Urogenital 305193 305193 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Chronic Kidney Disease Self-Management Support Intervention (CKD-SMS)

The intervention was guided by principles of person-centred care (PCC) and social-cognitive theory (SCT). Expert input assisted in guiding intervention and resource design. Intervention sessions are delivered by a researcher in CKD self-management with a background in psychology over a 12-week period.
Participants engage in two face-to-face intervention sessions, at week 1 and week 12, which take place in a mutually convenient location. Length of these sessions ranges from 20 to 90 minutes, dependent upon need. Between sessions, participants nominate preferred frequency of phone sessions (weekly, fortnightly, or monthly), which range from 5-60 minutes, as required. At the first session, participants and researcher collaborate to generate individualised self-management goals (e.g., engagement with treatment, understanding CKD). Individualisation is necessary because factors including comorbidity, level of education, and patient activation have a significant impact upon the type of SMS that patients with CKD require.
During the intervention, techniques from SCT are used to assist participants achieve their goals, as are motivational interviewing, cognitive-behavioural, and mindfulness techniques as appropriate.
Participants receive a handbook (adapted with permission from Kidney Health Australia’s “Living with Reduced Kidney Function” handbook; Kidney Health Australia, 2008) to accompany the intervention and to prompt discussion, as well as self-monitoring and note-taking handouts. All participants are encouraged to invite family members or friends to attend sessions.
As the intervention is person-centred, all self-monitoring and “homework” is optional and tailored to individuals. Participants are considered adherent if they engage in at least the two face-to-face sessions and one telephone session.
Intervention code [1] 299961 0
Lifestyle
Intervention code [2] 299962 0
Behaviour
Intervention code [3] 299963 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304348 0
Self-efficacy to manage CKD.

Self-report instrument: the Stanford Self-Efficacy for Managing Chronic Disease – 6-item Scale (SEMCD-6; Lorig et al., 1996).
Timepoint [1] 304348 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [1] 341673 0
Self-management of CKD.

Self-report instrument: Chronic kidney disease self-management instrument - Australian version (Aus.CKD-SM; Wembenyui et al., 2016). This 17-item survey investigates level of engagement in standard CKD self-management behaviours.
Timepoint [1] 341673 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [2] 341674 0
Health-related quality of life (HRQoL).

Self-report instrument: Australian 12-Item Short Form Survey, version 2 (SF-12; Ware et al., 1996).
Timepoint [2] 341674 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [3] 341675 0
CKD knowledge.

Self-report instrument: Kidney Knowledge Survey (KiKS; Wright et al., 2011). This 28-item survey consists of multiple-choice questions investigating general CKD knowledge.
Timepoint [3] 341675 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [4] 341676 0
Emotional distress.

Self-report instrument: Depression, Anxiety, Stress Scales – 21-item Version (DASS-21; Lovibond & Lovibond, 1995). This instrument distinguishes well between psychological disorders.
Timepoint [4] 341676 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [5] 341677 0
Understanding of physical activity guidelines

Self-report instrument: Four items from the active Australia survey (AAS; Australian Institute of Health and Welfare, 2003).
Timepoint [5] 341677 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [6] 341678 0
Engagement in physical activity.

Self-report instrument: the 94-item Human Activity Profile (HAP; Fix & Daughton, 1988).
Timepoint [6] 341678 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [7] 341679 0
Fruit and vegetable consumption

Self-reported: Two questions written by the researchers directly asking about fruit and vegetable consumption on day prior to assessment.
Timepoint [7] 341679 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [8] 341680 0
Communication with healthcare providers

Self-report instrument: Two items from the Partners in Health (PiH) scale (Battersby et al., 2003) directly assessing quality of communication and shared decision-making with healthcare providers.
Timepoint [8] 341680 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [9] 341681 0
Alcohol use.

Self-report instrument: The Alcohol Use Disorders Test Consumption questions (AUDIT-C; Bush et al., 1998), which consists of three multiple-choice questions.
Timepoint [9] 341681 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [10] 341682 0
Blood pressure (systolic and diastolic measurements; collected from patient records)
Timepoint [10] 341682 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [11] 341928 0
Weight (kilograms, collected from patient records)
Timepoint [11] 341928 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)
Secondary outcome [12] 341929 0
Estimated glomerular filtration rate (eGFR; collected from patient records)
Timepoint [12] 341929 0
Timepoint 1 = Baseline
Repeated measurement: Timepoint 2 = week 13 (one week post-intervention)

Eligibility
Key inclusion criteria
Diagnosis of chronic kidney disease; estimated glomerular filtration rate greater than or equal to 25 mL/min/1.73m2 (indicating stage 1-4 chronic kidney disease which has not progressed to a point where participants would have commenced pre-dialysis education); greater than or equal to 18 years of age; and ability to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Social or cognitive impairment which would inhibit participation; inability to be followed up (>60km from researcher’s location); and already receiving extensive CKD SMS.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Fifty-six participants were required to have 95% power to detect a medium effect (d = 0.50) in a paired t-test, assuming a 5% significance level (two-tailed; calculated using G*Power). These estimates were based upon results of Su and colleagues (2009) who used the same primary outcome (the SEMCD-6) with a similar population to evaluate a SCT-based intervention. Allowing for approximately 30% attrition, we recruited 78 participants.

Data is analysed using IBM SPSS Statistics version 23. Descriptive statistics are generated for background and clinical data, and baseline and follow-up results on patient-reported instruments and clinical measures are compared. Where data meets assumptions, paired-samples t-tests are conducted to assess change. Where data does not meet assumptions, non-parametric equivalent tests (Wilcoxon Signed-Rank tests) are conducted. Between-groups t-tests and Fisher’s exact tests are performed to assess for baseline differences between those who completed the intervention and those who did not.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/04/2016
Date of last participant enrolment
Anticipated
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
21/03/2017
Sample size
Target
78
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18439 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 298278 0
University
Name [1] 298278 0
Queensland University of Technology
Country [1] 298278 0
Australia
Funding source category [2] 298325 0
Government body
Name [2] 298325 0
National Health and Medical Research Council Chronic Kidney Disease Centre for Research Excellence
Country [2] 298325 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
QLD 4059
Country
Australia
Secondary sponsor category [1] 297441 0
None
Name [1] 297441 0
Address [1] 297441 0
Country [1] 297441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299282 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 299282 0
Ethics committee country [1] 299282 0
Australia
Date submitted for ethics approval [1] 299282 0
28/09/2015
Approval date [1] 299282 0
26/10/2015
Ethics approval number [1] 299282 0
HREC/15/QRBW/500
Ethics committee name [2] 299318 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [2] 299318 0
Ethics committee country [2] 299318 0
Australia
Date submitted for ethics approval [2] 299318 0
14/12/2015
Approval date [2] 299318 0
13/01/2016
Ethics approval number [2] 299318 0
1500001133

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2309 2309 0 0
/AnzctrAttachments/374210-RBWH HREC Approval.pdf (Ethics approval)
Attachments [2] 2310 2310 0 0
/AnzctrAttachments/374210-QUT HREC Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 79898 0
Ms Kathryn Havas
Address 79898 0
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
Queensland, 4059
Country 79898 0
Australia
Phone 79898 0
+617 3138 5957
Fax 79898 0
Email 79898 0
kathryn.havas@qut.edu.au
Contact person for public queries
Name 79899 0
Kathryn Havas
Address 79899 0
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
Queensland, 4059
Country 79899 0
Australia
Phone 79899 0
+617 3138 5957
Fax 79899 0
Email 79899 0
kathryn.havas@qut.edu.au
Contact person for scientific queries
Name 79900 0
Kathryn Havas
Address 79900 0
School of Nursing
Queensland University of Technology
Victoria Park Rd
Kelvin Grove
Queensland, 4059
Country 79900 0
Australia
Phone 79900 0
+617 3138 5957
Fax 79900 0
Email 79900 0
kathryn.havas@qut.edu.au

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

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