ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Early Detection / Screening

Comparator / control treatment

No control groups

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Patient activation level using a validated 13-item Patient Activation Measure

Timepoint [1]

Same day participant agrees to participate

Secondary outcome [1]

Treatment adherence to recommended immunization (COVID vaccine and flu vaccine) (data from EMR or asked to participants)

Timepoint [1]

When a participant agrees to participate - there is no follow up required

Secondary outcome [2]

Treatment adherence to medication adherence using a validated 8-item self-reported Morisky Medication Adherence Scale (MMAS) questionnaire.

Timepoint [2]

When a participant agrees to participate - there is no follow up required

Secondary outcome [3]

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]

When a participant agrees to participate - there is no follow up required

Secondary outcome [4]

Emergency visits and hospitalization admission rate over the last 12 months (data from EMR)

Timepoint [4]

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?

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)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [3]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [4]

Hampstead Rehabilitation Centre - Northfield

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5112 - Elizabeth Vale

Recruitment postcode(s) [3]

5011 - Woodville

Recruitment postcode(s) [4]

5085 - Northfield

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Central Adelaide Local Health Network (2022 RRC Allied Health Clinical Research Grant)

Address [1]

CALHN Research Services, Central Adelaide Local Health Network Inc. SA Health
Level 3, Roma Mitchell Building. 136 North Terrace, Adelaide, SA 5000

Country [1]

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]

Government body

Name [1]

Central Northern Adelaide Renal and Transplantation Service

Address [1]

Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide South Australia 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC) and CALHN Research Services.

Ethics committee address [1]

CALHN Research Services, Central Adelaide Local Health Network Inc., SA Health
Level 3, Roma Mitchell Building, 136 North Terrace, Adelaide, SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/02/2022

Approval date [1]

02/03/2022

Ethics approval number [1]

16067

Summary

Brief summary

Chronic kidney disease (CKD) is a complex health condition that has a profound impact on an individual’s general health and wellbeing and consumes enormous economic resources. The lifetime of living with CKD requires individuals to actively manage their own healthcare needs where possible. 

Health services in Australia have had limited success in encouraging self-management among people with CKD. To overcome these low levels of self-management, a new patient activation approach has been identified. Patient activation requires relevant healthcare knowledge, skills, and confidence in order to achieve optimal self-management. A growing body of research in chronic conditions has shown low activation is associated with higher symptom burden, higher hospital admissions rates and reduced health-related quality of life. However, a complete understanding of patient activation in the CKD population is limited, creating a challenge to develop the strategies required to address low patient activation and low self-management. 

This study aims to identify:
(1)	the current status of patient activation levels in people with advanced CKD  
(2)	measure the association between patient activation and patient sociodemographic characteristics, clinical variables, treatment adherence and emergency visits/hospital admission rate. 

This study will result in a better understanding of patient activation and enable kidney care teams to target appropriate individuals and propose strategies to move towards a more active role for patients and their family in their own health care.

Trial website

Trial related presentations / publications

Public notes

A KCP introduced in 2020 at CNARTS is a multidisciplinary renal model of care for patients with CKD stages 4-5 not receiving dialysis. Renal patients are referred to this program by CNARTS nephrologists and renal registrars only. This program, led by two CKD Nurses Consultant and three Nurse Practitioners working collaboratively with the patient’s nephrologist and the multidisciplinary renal team, has the aim to improve patient’s renal journey providing a single point of contact for the patient at any point of their advanced CKD in the transition to dialysis and transplantation. Hence, the CKD population followed by the KCP is ideal for capturing patient-reported measures, such as patient activation, which has never been measured at CNARTS before.

Contacts

Principal investigator

Name

Dr Laura Lunardi

Address

Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 08 7074 5441

Fax

+61 08 7074 6222

laura.lunardi@sa.gov.au

Contact person for public queries

Name

Laura Lunardi

Address

Royal Adelaide Hospital
Level 7F 401
North Terrace
Adelaide SA 5000

Country

Australia

Phone

+61 08 7074 5441

Fax

+61 08 7074 6222

laura.lunardi@sa.gov.au

Contact person for scientific queries

Name

Paul Bennett

Address

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

Australia

Phone

+61 08 83022662

Fax

Paul.Bennett@unisa.edu.au

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 (laura.lunardi@sa.gov.au)

What supporting documents are/will be available?

Doc. No.	Type	Other Details	Attachment
15327	Study protocol		383708-(Uploaded-07-03-2022-22-52-39)-Study-related document.docx
15328	Ethical approval		383708-(Uploaded-07-03-2022-22-45-02)-Study-related document.pdf
15329	Informed consent form		383708-(Uploaded-07-03-2022-22-49-55)-Study-related document.docx
15332	Other	Study Flyer	383708-(Uploaded-07-03-2022-22-59-11)-Study-related document.docx

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.

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