Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000451707
Ethics application status
Approved
Date submitted
8/03/2022
Date registered
23/03/2022
Date last updated
27/02/2023
Date data sharing statement initially provided
23/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient activation in chronic kidney disease
Scientific title
Identifying individuals’ level of knowledge, skill, and confidence using Patient Activation Measure-13 (PAM-13) in patients with chronic kidney disease stage 5 not receiving dialysis
Secondary ID [1] 306613 0
This study has funding secured by Royal Adelaide Hospital Research Committee - 2022 RRC Allied Health, Pharmacy and Nursing Clinical Research Grant. MYIP: 15816.
Universal Trial Number (UTN)
U1111-1275-4967
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic kidney disease 325533 0
Condition category
Condition code
Renal and Urogenital 322903 322903 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Flyers of the study will be distributed in all CNARTS outpatient renal clinics. All patients who meet the inclusion criteria will be approached by the Kidney Care Program (KCP) nurse involved in the patient’s care. Potential participants will be approached:

(1) in-person when they attend the renal appointments at Central Northern Adelaide Renal and Transplantation Service (CNARTS) outpatient settings (RAH, QEH, Hampstead & LMH) to provide information of the study and invite to participate. The nurse will provide the potential participant with the flyer of the study and the Participant Information and Consent Form (PICF) with details of the study and sufficient time to read this form and ask questions. If the individual agrees to participate, the patient will be asked to sign the Consent Form prior to commencing the study.
(2) via telehealth or telephone: detailed information of the study will be provided. If the individual agrees to participate, the Remote Informed Consent Confirmation Form (Form RC) will be verbally consented prior or after the participant review of the PICF that will be forwarded to the participant via email or via post. The participant must be given sufficient time to read PICF and ask questions.

Participants will be informed that they are free to decide not to participate, and to withdraw from the study at any time. Participants will be informed that their decision will not in any way affect their current or future care by their treating renal team. The participant will have LL (principal investigator) contact details to contact if a question arises.

For individuals participating in the study, two surveys (a 13-point Patient Activation Measure (PAM-13) and the 8-point Morisky Medication Adherence Scale (MMAS)) will be provided only once to complete some demographic questions. Each questionnaire will take approximately 10 minutes to complete.

Demographic, clinical and outcome data will be extracted by local investigators from participants and electronic medical records on paper and then into a pre-developed SA Health-based REDCap program.

Treatment adherence to recommended vaccinations (Covid and flu vaccine), renal outpatient appointment non-adherence, emergency visits, and the hospitalization admission rate will be assessed; this additional data will be collected from medical records only, with no further involvement by the participant required.

All data will be de-identified in REDCap before being analysed by local investigators (LL, MB, RL and a research assistance to recruit).

Data will be collected from 1st of July 2022 to 31st March 2023.
Intervention code [1] 323053 0
Early Detection / Screening
Comparator / control treatment
No control groups
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330678 0
Patient activation level using a validated 13-item Patient Activation Measure
Timepoint [1] 330678 0
Same day participant agrees to participate
Secondary outcome [1] 407347 0
Treatment adherence to recommended immunization (COVID vaccine and flu vaccine) (data from EMR or asked to participants)
Timepoint [1] 407347 0
When a participant agrees to participate - there is no follow up required
Secondary outcome [2] 407348 0
Treatment adherence to medication adherence using a validated 8-item self-reported Morisky Medication Adherence Scale (MMAS) questionnaire.
Timepoint [2] 407348 0
When a participant agrees to participate - there is no follow up required
Secondary outcome [3] 407636 0
Treatment non-adherence: sum of all missed number of renal outpatients’ appointments in the last 12 months (data from EMR), and cause of the missed appointment as reported in the EMR.
Timepoint [3] 407636 0
When a participant agrees to participate - there is no follow up required
Secondary outcome [4] 407637 0
Emergency visits and hospitalization admission rate over the last 12 months (data from EMR)
Timepoint [4] 407637 0
When a participant agrees to participate - there is no follow up required

Eligibility
Key inclusion criteria
-Chronic Kidney Disease stage 5, also called End Stage Kidney Disease
- Stage 5: less than or equal to eGFR below 15 ml/min/1.73 m2
-Aged: greater than or equal to 18
-Referred to the Kidney Care Program (new and existing)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent and/or participate in the study
• Patients admitted in hospital
• Kidney transplanted patients
• Patients undergoing dialysis

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Analysis for research aim 1: The transformed patient activation score will be generated according to the scoring protocol of PAM-13. The transformed score ranges from 0 to 100. Patients with transformed score of less than or equal to 55.1 are classified as having low activation. The proportion of CKD patients assessed having low activation will be calculated.

Analysis for research aim 2:
- Relationship between PAM score and sociodemographic factors (age, gender, marital status, ethnicity (using the Australian New Zealand Data Registry (ANZDATA) definition), residence location (metro or rural based on person’s residential postcode), home supported living, level of education and socio-economic status. (Data will be collected from patients and the electronic medical records (EMR)
Socio-economic status will be calculated using the 2016 Australian Bureau of Statistics data; Postcodes will be classified in accordance with the Index of Relative Social Disadvantage (IRSD), an index that provides a summary on a variety of data about the socio- economic conditions of people living in an area.
Appropriate univariate analysis will be performed to explore the relationship between each sociodemographic factor and patient activation level. Contingency table will be used for testing relationship between two categorical variables; independent sample t-test (or Mann-Whitney test as the corresponding non-parametric test) will be used in the combination of continuous and categorical variables.

-Relationship between PAM and medication adherence
Linear regression will be used to examine the relationship between patient activation and medication adherence level. Modified Morisky score will be the outcome variable, and PAM-13 score the predictor variable. Assumptions of linear regression including constant variance, normality of the Modified Morisky score, and linearity between PAM and medication adherence will be checked.

-Relationship between PAM and treatment adherence; PAM and ED visits.
Generalized linear model will be used to model the relationship between 1) PAM and treatment non-adherence; and 2) PAM and yearly hospital visits. The number of treatment non-adherence, and the number of hospital visits are both count data. Accordingly, in implementing the generalized linear model, a link function suitable for count data, such as negative binomial distribution, will be selected.
The ultimate choice of link function will be informed by the assessment of the distribution of the number of treatment nonadherence, and the number of hospital visits within the sample.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2022
Actual
1/07/2022
Date of last participant enrolment
Anticipated
31/03/2023
Actual
23/01/2023
Date of last data collection
Anticipated
31/03/2023
Actual
23/01/2023
Sample size
Target
350
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21895 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 21896 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [3] 21897 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [4] 21898 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 36979 0
5000 - Adelaide
Recruitment postcode(s) [2] 36980 0
5112 - Elizabeth Vale
Recruitment postcode(s) [3] 36981 0
5011 - Woodville
Recruitment postcode(s) [4] 36982 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 310947 0
Government body
Name [1] 310947 0
Central Adelaide Local Health Network (2022 RRC Allied Health Clinical Research Grant)
Country [1] 310947 0
Australia
Primary sponsor type
Individual
Name
Laura Lunardi
Address
Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide South Australia 5000
Country
Australia
Secondary sponsor category [1] 312248 0
Government body
Name [1] 312248 0
Central Northern Adelaide Renal and Transplantation Service
Address [1] 312248 0
Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide South Australia 5000
Country [1] 312248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310506 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC) and CALHN Research Services.
Ethics committee address [1] 310506 0
Ethics committee country [1] 310506 0
Australia
Date submitted for ethics approval [1] 310506 0
11/02/2022
Approval date [1] 310506 0
02/03/2022
Ethics approval number [1] 310506 0
16067

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

Contacts
Principal investigator
Name 117890 0
Dr Laura Lunardi
Address 117890 0
Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide SA 5000
Country 117890 0
Australia
Phone 117890 0
+61 08 7074 5441
Fax 117890 0
+61 08 7074 6222
Email 117890 0
[email protected]
Contact person for public queries
Name 117891 0
Laura Lunardi
Address 117891 0
Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide SA 5000
Country 117891 0
Australia
Phone 117891 0
+61 08 7074 5441
Fax 117891 0
+61 08 7074 6222
Email 117891 0
[email protected]
Contact person for scientific queries
Name 117892 0
Paul Bennett
Address 117892 0
UniSA Clinical and Health Sciences, University of South Australia
C6-39, Centenary Building, City East Campus
Corner of North Terrace and Frome Rd
Adelaide, South Australia, 5001

Country 117892 0
Australia
Phone 117892 0
+61 08 83022662
Fax 117892 0
Email 117892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All the individual participant data collected during the trials, after de-identification.
When will data be available (start and end dates)?
available for 5 years after publication
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approval by Principal Investigator ([email protected])


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.