Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000841279
Ethics application status
Approved
Date submitted
28/09/2009
Date registered
28/09/2009
Date last updated
26/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Survey of unexpected events in palliative Care.
Scientific title
A Pilot Survey to identify if there are unexpected troublesome events occuring in Palliative Care patients that may be related to how medications are prescribed at the end of life, resulting in anti-cholinergic load.
Secondary ID [1] 284345 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total anti-cholinergic load in Palliative Care participants. 251914 0
Condition category
Condition code
Other 252064 252064 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study, looking at troublesome symptoms, which include breathlessness at rest, breathlessness showering or dressing, urinary incontinence, difficulty passing urine, urinary frequency, nocturia, constipation, diarrhoea, rash, light headedness or dizzy when standing, feeling muddled, difficulty remembering things which happened earlier in the day,difficulty concentrating, vivid dreams or hallucinations, nightmares, night time confusion, blurred vision. falls, headaches, being easily irritated, that may be caused by the total anti-cholinergic load in Palliative Care Participants.
This total anti-cholinergic load is generated by the sum of the medications with anti-cholinergic activity. Given that a threshold for symptomatic problems appears likely, understanding the total anti-cholinergic load and how the load changes as a result of prescribing at the end of life is crucial. In addition to the traditional anti-muscarinic medications, increasing evidence suggests many other medications have anti-cholinergic properties including commonly encountered medication such as warfarin, ranitidine, digoxin, codeine and diazepam Many of these medications are continued or commenced during the end-of-life care period.How do Participants experience these effects in a setting where their bodies are often changing rapidly. Fundamentally, are there effects from prescribing that fail to take account of increasing numbers of medications, and from the rapid systemic changes that occur as death approaches such as weight loss, cachexia and impaired organ function.
Participants once consented will be asked to complete a self assessment diary identifying any of the above mentioned symptoms, their frequency and level of distress they cause to the participant. Then daily for 8 weeks the participant will be asked to fill out a diary to document any of these troublesome symptoms experienced in the past 24 hours. If the participant is too tired, the diary can be completed by a carer or family member, this would be noted on the diary. Completing the diary should take less than 10 minutes each day.
Lastly the participant will be phoned weekly by the study nurse for 8 weeks and will be asked about any troublesome symptoms experienced, any changes in their quality of life,level of mobility, self efficacy, independence, and any deterioration in their condition.So the duration of participant involvement in the study is 8 weeks.
Intervention code [1] 241320 0
Not applicable
Comparator / control treatment
no treatment obervational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 252972 0
To identify if there are events that the participant may find troublesome that could be related to how medications are prescribed at the end of life. This will be measured by a Participant Self Assessment diary which will measure the frequency, severity and distress associated with 20 symptom which are: - breathlessness at rest, breathlessness showering or dressing, urinary incontinence, difficulty passing urine, urinary frequency, nocturia, constipation, diarrhoea, rash, light headedness or dizzy when standing, feeling muddled, difficulty remembering things which happened earlier in the day,difficulty concentrating, vivid dreams or hallucinations, nightmares, night time confusion, blurred vision. falls, headaches, being easily irritated.
Timepoint [1] 252972 0
At baseline and daily for 8 weeks.
Secondary outcome [1] 257723 0
Co- morbidity status measured by the Charlson Co-Morbidity Index.Co-morbid conditions will be recorded using the Charlson Comorbidity Index which incorporates in a single score, the severity and number of co morbid conditions. [Charlson 1987] The index is an independent predictor of long term survival,
Timepoint [1] 257723 0
baseline
Secondary outcome [2] 257724 0
Patient self-efficacy measured by the Australian-modified Karnofsky Performance Status Scale.
Timepoint [2] 257724 0
At baseline and weekly for 8 weeks
Secondary outcome [3] 257725 0
Patient level of independence measured by the RUG-ADL ( the Resourse Utilisation Group-Activities of Daily Living) a four item scale measuring motor function with activities of daily living including bed mobility, toileting , transfer and eating.
Timepoint [3] 257725 0
At baseline and weekly for 8 weeks
Secondary outcome [4] 257726 0
Patient quality of life measured by the McGill Quality of Life Questionnaire.
Timepoint [4] 257726 0
At baseline and weekly for 8 weeks.
Secondary outcome [5] 257727 0
Stage of patient's illness measured by the Australian Natinal Sub-Acute and non-Acute Patient Classification (AN-SNAP) in terms of 5 phases including stable, unstable, deteriorating, terminal and bereaved.
Timepoint [5] 257727 0
At baseline and weekly for 8 weeks.
Secondary outcome [6] 257728 0
Patient mobility - measured by the Life-Space Assessment, designed by the University of Birmingham Alabama USA. It is is a new instrument to evaluate mobility.
Timepoint [6] 257728 0
At baseline, week 4 and week 8 of study.
Secondary outcome [7] 257729 0
Patient's level of distress caused by symptoms, measured by the Symptom Assessment Score (SAS). A seven item paient rated tool measuring symptom distress in cancer and palliative care patients. 7 key symptoms include insomnia, appetite problems, nausea, bowels, breathing, fatigue and pain.
Timepoint [7] 257729 0
baseline and weekly for 8 weeks.

Eligibility
Key inclusion criteria
Participants referred to Southern Adelaide Palliative Services community team,
Participants with a prognosis of at least 3 months in the opinion of the treating physician, English speaking with sufficient reading and writing ability to compete the study diary. (Caregivers may fill out the diary at the direction of the participant)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent or complete study log for any reason, Cognitive impairment with Folstein Mini-mental Status Exam <24/30 at recruitment Severely restricted performance status with an Australian Modified Karnofsky Performance Status Scale (AKPS) score of <50 at baseline.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
16/10/2009
Date of last participant enrolment
Anticipated
29/03/2010
Actual
29/03/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243782 0
Self funded/Unfunded
Name [1] 243782 0
Southern Adelaide Palliative Services
Country [1] 243782 0
Australia
Primary sponsor type
University
Name
Flinders University - Department of Palliative and Support Services
Address
700 Goodwood Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 237139 0
None
Name [1] 237139 0
Address [1] 237139 0
Country [1] 237139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243913 0
Flinders Research Ethics Committee and the Clinical Drug Trials Committee.
Ethics committee address [1] 243913 0
Ethics committee country [1] 243913 0
Australia
Date submitted for ethics approval [1] 243913 0
Approval date [1] 243913 0
11/09/2009
Ethics approval number [1] 243913 0
40/09

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

Contacts
Principal investigator
Name 30312 0
Prof David Currow
Address 30312 0
Department of Palliative and Supportive Services - Flinders University 700 Goodwood road Daw Park SA 5041
Country 30312 0
Australia
Phone 30312 0
+61 8 8275 1871
Fax 30312 0
+61 8 8374 0350
Email 30312 0
[email protected]
Contact person for public queries
Name 13559 0
Professor David Currow
Address 13559 0
Department of Palliative and Supportive Services - Flinders University

700 Goodwood road

Daw Park SA 5041
Country 13559 0
Australia
Phone 13559 0
+61 8 8275 1871
Fax 13559 0
+61 8 8374 0350
Email 13559 0
[email protected]
Contact person for scientific queries
Name 4487 0
Professor David Currow
Address 4487 0
Department of Palliative and Supportive Services - Flinders University

700 Goodwood road

Daw Park SA 5041
Country 4487 0
Australia
Phone 4487 0
+61 8 8275 1871
Fax 4487 0
+61 8 8374 0350
Email 4487 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.