Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000782033
Ethics application status
Approved
Date submitted
9/09/2010
Date registered
21/09/2010
Date last updated
21/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
End-of-Life Care in End Stage Renal Disease: Integration of an advance care planning process
Scientific title
End-of-Life Care in End Stage Renal Disease: Integration of an advance care planning process
Secondary ID [1] 1059 0
CRG080700118 (Cochrane Renal Group)
Universal Trial Number (UTN)
Trial acronym
ACP in CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-dialysis (clinically expected to start dialysis within 12 months) and incident dialysis patients 243774 0
Condition category
Condition code
Renal and Urogenital 258164 258164 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
facilitated advance care planning conversations with documentation of any resultant decision-making. This will involve a semi-structured interview that addresses goals of care and treatment options as well as end-of-life decision making that will be lead by a single trained facilitator. The conversations will take on average 1 hour and follow-up conversations will occur on an as neded basis depending up[on the needs of the individual patients. Family members will be involved in these conversations if identified as patients as being important for decison-making. It is anticipated that for those patients who have family members that live in close proximity, that family participation will be requested by the patient.
Intervention code [1] 257045 0
Other interventions
Comparator / control treatment
standard treatment: patient would have to specifically ask to engage in conversations about end-of-life care and this would not be a standardized conversation and would depend upon the physician caring for that patient.
Control group
Active

Outcomes
Primary outcome [1] 240843 0
psychosocial adjustment to illness using the Psychosocial Adjustment to Illness Scale (PAIS)
Timepoint [1] 240843 0
12 and 24 months after the initial advance care planning conversation.
Primary outcome [2] 259030 0
depression using the Beck depression Inventory-II (BDI),
Timepoint [2] 259030 0
12 and 24 months after the initial advance care planning conversation.
Primary outcome [3] 259031 0
Hope using the Herth Hope Index (HHI)
Timepoint [3] 259031 0
12 and 24 months after the initial advance care planning conversation.
Secondary outcome [1] 257513 0
Health-Related Quality of Life using the Kidney Disease Quality of Life (KDQOL) questionnaire.
Timepoint [1] 257513 0
12 and 24 months after the initial advance care planning conversation.
Secondary outcome [2] 265285 0
Cost effectiveness from the participants' perspectives using the Health Utilities Index (HUI3) and 6 Dimensions of the Short form (SF-6D) as indirect utility measures.
Timepoint [2] 265285 0
12 and 24 months after the initial advance care planning conversation.
Secondary outcome [3] 265286 0
Dying experience using the Quality of Dying and Death (QODD) Interview for all patients deaths
Timepoint [3] 265286 0
Follow the death of all patients who die within 3 years following completion of the initial advance care planning conversation.
Secondary outcome [4] 265287 0
coping mechanisms using the Brief Cope questionnaire
Timepoint [4] 265287 0
12 and 24 months after the initial advance care planning conversation.
Secondary outcome [5] 265288 0
Spirituality using the Spiritual Perspective Scale (SPS)
Timepoint [5] 265288 0
12 and 24 months after the initial advance care planning conversation.

Eligibility
Key inclusion criteria
1. Patients: 1) incident pre end stage renal disease (ESRD) enrolled within the Renal Insufficiency Clinic at the University of Alberta with an expected time to dialysis of less than 12 months* or (2) incident cases of ESRD where patients have just started chronic hemodialysis or peritoneal dialysis within the past 1 month, (3) older than 18 years of age, (4) cognitively able to complete the questionnaires and give informed consent, and (5) able to converse and complete the questionnaires in English.

2. Family: (1) the primary family caregiver; (2) older than 18 years of age; (3) cognitively able to complete the questionnaires and give informed consent; and (4) able to converse and complete the questionnaires in English.

* Nephrologists are required to assess whether the patient is likely to progress to ESRD within 6 or 12 months upon referral to the Renal Insufficiency Clinic ( based on clinical judgment).
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not meet criteria as indicated above.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2096 0
Canada
State/province [1] 2096 0
Alberta

Funding & Sponsors
Funding source category [1] 243676 0
Hospital
Name [1] 243676 0
University Hospital Foundation
Country [1] 243676 0
Canada
Primary sponsor type
Hospital
Name
University Hospital Foundation
Address
11-107 Clinical Sciences Building
8440 112 St
Edmonto AB T6G 2B7
Country
Canada
Secondary sponsor category [1] 256846 0
University
Name [1] 256846 0
University of Alberta
Address [1] 256846 0
11-107 Clinical Sciences Building
8440 112 St
Edmonto AB T6G 2B7
Country [1] 256846 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259643 0
University Of Alberta Research Ethics Board
Ethics committee address [1] 259643 0
Ethics committee country [1] 259643 0
Canada
Date submitted for ethics approval [1] 259643 0
Approval date [1] 259643 0
Ethics approval number [1] 259643 0

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

Contacts
Principal investigator
Name 30228 0
Address 30228 0
Country 30228 0
Phone 30228 0
Fax 30228 0
Email 30228 0
Contact person for public queries
Name 13475 0
Dr, Sara, Davison
Address 13475 0
Assistant Professor, Medicine, University of Alberta, 11-107 Clinical Sciences Building, Edmonton AB T6G 2G3
Country 13475 0
Canada
Phone 13475 0
+1 780 407 8716
Fax 13475 0
Email 13475 0
[email protected]
Contact person for scientific queries
Name 4403 0
Jeannine Flores
Address 4403 0
Study Coordinator, Medicine, University of Alberta, 11-107 Clinical Sciences Building, Edmonton AB T6G 2G3
Country 4403 0
Canada
Phone 4403 0
+1 780 407 8716
Fax 4403 0
Email 4403 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
No additional documents have been identified.