Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000120572
Ethics application status
Not yet submitted
Date submitted
14/01/2015
Date registered
10/02/2015
Date last updated
5/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a pilot support intervention for informal caregivers of people with motor neuron disease on psychological morbidity
Scientific title
Effect of a pilot support intervention for informal caregivers of people with motor neuron disease on psychological morbidity
Secondary ID [1] 285940 0
Nil
Universal Trial Number (UTN)
U1111-1166-0109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caregiver Burden 293890 0
Condition category
Condition code
Mental Health 294194 294194 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a one-off group based intervention with a duration of two hours thirty minutes. The purpose of this group based activity will be to create a supportive environment to share personal experiences about changes to the caregiver's life associated with caring for a person with Motor Neuron Disease. It will also provide a supportive environment to learn about mindfulness, problem solving and other support resources available. The intervention will be administered by two psychologists to a small group of caregivers.
Intervention code [1] 290933 0
Behaviour
Comparator / control treatment
There is no control group. The same intervention is applied to all subjects in the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293981 0
Outcome 1: Cognitive and Affective Mindfulness Scale-Revised score
Timepoint [1] 293981 0
Timepoint 1 (baseline) and timepoint 3 (two months after intervention)
Primary outcome [2] 293982 0
Outcome 2: Brief Symptom Inventory 18 score
Timepoint [2] 293982 0
Timepoint 1 (baseline) and timepoint 3 (two months after intervention)
Primary outcome [3] 293983 0
Outcome 3: Caregiver Reaction Assessment score
Timepoint [3] 293983 0
Timepoint 1 (baseline) and timepoint 3 (two months after intervention)
Secondary outcome [1] 312274 0
Outcome 1: Acceptability of intervention questionnaire. Assessed by brief survey created by the Researchers of the study (it is not a formal / previously validated tool).
Timepoint [1] 312274 0
Timepoint 2 (within 1 week of intervention) and timepoint 3 (two months after intervention)

Eligibility
Key inclusion criteria
1. Informal caregiver of person diagnosed with motor neuron disease in the past twelve months;
2. Be at least 18 years of age;
3. Be able to read, write and speak English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosed with a severe cognitive or psychological disorder;
2. Unaware of the diagnosis of the person they care for.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects allocated to intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analyses will summarise the sample and the evaluation form. Paired samples t tests will be used to compare the data from the questionnaire booklet before and after the intervention, however, results will be interpreted with caution given this is a pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2015
Actual
Date of last participant enrolment
Anticipated
31/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3320 0
Calvary Health Care Bethlehem Ltd - Caulfield
Recruitment postcode(s) [1] 9101 0
3162 - Caulfield South

Funding & Sponsors
Funding source category [1] 290540 0
Charities/Societies/Foundations
Name [1] 290540 0
Bethlehem Griffiths Research Foundation.
Country [1] 290540 0
Australia
Primary sponsor type
Hospital
Name
Centre for Palliative Care St Vincent's Hospital
Address
Centre for Palliative Care
PO Box 2900
Fitzroy
Vic 3065
Country
Australia
Secondary sponsor category [1] 289232 0
University
Name [1] 289232 0
Deakin University
Address [1] 289232 0
Faculty of Health
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [1] 289232 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292186 0
Calvary Health Care Bethlehem Research Ethics & Ethics Committee
Ethics committee address [1] 292186 0
Calvary Health Care Bethlehem, 476 Kooyong Road, Caulfield South, Victoria, 3162
Ethics committee country [1] 292186 0
Australia
Date submitted for ethics approval [1] 292186 0
30/01/2015
Approval date [1] 292186 0
Ethics approval number [1] 292186 0

Summary
Brief summary
This study aims to develop, provide and evaluate a new group based activity for people who provide care for someone with Motor Neuron Disease. The purpose of this group based activity will be to create a supportive environment to share personal experiences about changes to the caregiver's life associated with caring for a person with Motor Neuron Disease. It will also provide a supportive environment to learn about mindfulness, problem solving and other support resources available. The intervention will be administered by two psychologists to a small group of caregivers.
Trial website
Trial related presentations / publications
Public notes
The ethics application for the study has been submitted. We have had a delayed response and we expect approval to be obtained at the end of February and will update this account when able.

Contacts
Principal investigator
Name 53918 0
Dr Anna Ugalde
Address 53918 0
Deakin University
Faculty of Health
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 53918 0
Australia
Phone 53918 0
+61 3 9244 3739
Fax 53918 0
Email 53918 0
[email protected]
Contact person for public queries
Name 53919 0
Dr Anna Ugalde
Address 53919 0
Deakin University
Faculty of Health
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 53919 0
Australia
Phone 53919 0
+61 3 9244 3739
Fax 53919 0
Email 53919 0
[email protected]
Contact person for scientific queries
Name 53920 0
Dr Anna Ugalde
Address 53920 0
Deakin University
Faculty of Health
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country 53920 0
Australia
Phone 53920 0
+61 3 9244 3739
Fax 53920 0
Email 53920 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4506Study results articleYes Ugalde A, Mathers S, Hennessy Anderson N, Hudson P... [More Details]

Documents added automatically
No additional documents have been identified.