Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000489695
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
12/05/2014
Date last updated
20/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
PACE Telehealth (Pain Activity and Coping Education): A Pilot program to investigate the feasibility of a contemporary model of interdisciplinary chronic pain management using group “Face to Face” interventions combined with individual Telehealth mentoring for young people and their parents.
Scientific title
PACE Telehealth (Pain Activity and Coping Education): A Pilot program to investigate the feasibility of a contemporary model of interdisciplinary chronic pain management using group “Face to Face” interventions combined with individual Telehealth mentoring for young people (11-17) and their parents to assess physical and psychological function, school attendance and parent impact.
Secondary ID [1] 283832 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
PACE Telehealth (Pain Activity and Coping Education):
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pain 290810 0
Condition category
Condition code
Anaesthesiology 291589 291589 0 0
Pain management
Physical Medicine / Rehabilitation 292188 292188 0 0
Physiotherapy
Physical Medicine / Rehabilitation 292189 292189 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PACE is a structured (Cognitive Behavioural) CBT pain intervention involving:
Week One - The child and one parent or guardian will attend a 7 hour group workshop at Princess Margaret Hospital (PMH). Adults and children will participate in sessions in seperate rooms with up to 7 other participants and two staff members. Topics will include: The Neuroscience of Pain, Cognitive Strategies, Activity Management & Exercise, School, Communication, Mindfulness, Sleep, Flare Up and Set Back Planning and Where to From Here?
Week 2 to 5 - The family will be allocated a "key-worker" who is either the program physiotherapist, occupational therapist or clinical psychologist. The child and their parent or guardian will have seperate, individualised weekly Telehealth support sessions of up to 30 minutes with their keyworker. These will include a video link similar to Skype. These sessions will reinforce topics and skills learnt in the workshop. The three program therapists will meet weekly to discuss the participant's progress and provide interdisciplinary support. Children who score over clinical thresholds on the Revised Children Anxiety and Depression Scale will be allocated a clinical psychologist as their keyworker.
Week 7 - the child and their parent/guardian will attend a 4 hour review at PMH
The treatment team will be led by a physiotherapist and included a Clinical Psychologist and Occupational Therapist. All treatment will have a strong Cognitive Behavioural framework and there will be strong "cross-linking" between disciplines.
The children will be asked to complete charts related to activity management, cognitive strategies and flare up and set back planning. These will be monitored in the Telehealth sessions. Parents will be monitored by verbal questioning with the emphasis on supporting skills aquisition.
Intervention code [1] 288853 0
Treatment: Other
Intervention code [2] 289327 0
Behaviour
Intervention code [3] 289328 0
Rehabilitation
Comparator / control treatment
Standard Care will constitute individual “face to face” consultations of Physiotherapy, Occupational Therapy and Clinical Psychology and will continue for as long as determined necessary by the individual therapists.
Control group
Active

Outcomes
Primary outcome [1] 291594 0
Change in Bath Adolescent Pain Questionnaire
Timepoint [1] 291594 0
Baseline and Weeks 7 & 11
Primary outcome [2] 291595 0
Change in Functional Disability Index score
Timepoint [2] 291595 0
Baseline and Weeks 7 & 11
Primary outcome [3] 291596 0
Change in BAPQ Parent Impact Questionnaire
Timepoint [3] 291596 0
Baseline and Weeks 7 &11
Secondary outcome [1] 307136 0
Change in Child Self Efficacy Scale.
Timepoint [1] 307136 0
Baseline and Week 7 and 11
Secondary outcome [2] 307137 0
Change in Fear of Pain Questionnaire
Timepoint [2] 307137 0
Baseline and Week 7 & 11
Secondary outcome [3] 307138 0
Change in sleep question from PROMIS
Timepoint [3] 307138 0
Baseline and Week 7 &11
Secondary outcome [4] 307139 0
Change in Revised Child Anxiety and Depression Scale
Timepoint [4] 307139 0
Baseline and Weeks 7 & 11
Secondary outcome [5] 307140 0
Role Function – School Attendance - change in hours attaended school in the last two weeks
Timepoint [5] 307140 0
Baseline and Weeks 7 & 11
Secondary outcome [6] 307141 0
Economic Impact (Travel and Time)
The travel and time demands on the family related to attending appointments
Timepoint [6] 307141 0
Baseline and Weeks 7 & 11
Secondary outcome [7] 307142 0
Global Satisfaction using scale as described in IMMPACT guidelines for paediaric pain research
Timepoint [7] 307142 0
Baseline and Weeks 7 & 11
Secondary outcome [8] 307143 0
Average pain over the last two weeks using a visual analogue scale.
Timepoint [8] 307143 0
Baseline and Weeks 7 & 11
Secondary outcome [9] 307144 0
Qualitative feedback using questionnaire to ask what aspects of intervention worked best and least and what could be done to improve the intervention.
Timepoint [9] 307144 0
Baseline and Week 11

Eligibility
Key inclusion criteria
*Age 11 to 17 years old.
*Experience pain on average at least 4 days a week.
*Pain present for greater than 3 months (includes Chronic Widespread Pain Syndrome, Fibromyalgia, Headaches, Functional Abdominal Pain).
*Under the care of a medical specialist at Princess Margaret Hospital and untreated pathology (other than their chronic pain syndrome) excluded.
*One adult family member willing to participate.
*No major changes in the patient’s medical management anticipated in the next four months.
*Family have access to phone, Internet and e-mails at their home, community health centre or other convenient location.
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*High dependency on analgesic medication.
*Fatigue as their primary symptom.
*Current or previous treatment for cancer.
*Pain explained by identified pathological process (eg rheumatological disease or inflammatory bowel disease).
*Language barriers or hearing, literacy or learning difficulties that would affect the patient or parent’s ability to comprehend the principles taught on the Program.
*Co-existing psychiatric or psychosocial issues were considered more relevant to the patient’s reduced function than their pain was.
*Significant mental health disorder including Bipolar Disorder, Psychosis, active suicidality or Eating Disorders.
*Documented developmental delay.
*Currently participating in other rehabilitation program or cognitive behavioural therapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following the completion of consent forms the participant will be given a research code and asked to complete the Functional Disability Index (FDI).

After completing the FDI the participant will be randomly allocated to either Group 1 (Standard Care) or Group 2 (PACE). It will be assumed that participants with similar degrees of physical function will have similar potential to respond clinically. Therefore, in order to ensure randomisation and obtain equivalent groups based on functional limitation, a matched allocation process will occur. To be a match, the participant has to be within the same category of physical function as assessed by the score on the FDI. These categories are No/Minimal Disability category (6-12), Moderate Disability category (13–29) and Severe Disability category (30+).

After the FDI assessment an independent person will draw a marble from a concealed bag containing 24 white marbles (indicating Group 1) and 24 coloured marbles (indicating Group 2). Once selected, the marble will not be replaced in the bag. This process will not occur if the participant constituted a match for a previously enrolled participant. If on enrolment the participant constitutes a match for a previously enrolled participant, they will be assigned to the group that does not include their match and the corresponding marble to their group allocation will be removed from the bag to maintain the probability.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
1/11/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2173 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 7854 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 288830 0
Charities/Societies/Foundations
Name [1] 288830 0
Princess Margaret Hospital Allied Health Telethon Fellowship
Country [1] 288830 0
Australia
Primary sponsor type
Individual
Name
Anna Hilyard
Address
Physiotherapy Department
Princess Margaret Hospital
Hay St
Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 287524 0
None
Name [1] 287524 0
Address [1] 287524 0
Country [1] 287524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290670 0
PMH Human Reserach Ethics Committee
Ethics committee address [1] 290670 0
PMH HREC
PMH
Hay St
Subiaco
WA 6008
Ethics committee country [1] 290670 0
Australia
Date submitted for ethics approval [1] 290670 0
12/01/2014
Approval date [1] 290670 0
17/04/2014
Ethics approval number [1] 290670 0
2014-016EP

Summary
Brief summary
Severe chronic pain affects up to 8% of adolescents, with many suffering from significant emotional distress and physical disability. This often limits school attendance and impacts on the family as a whole.

This pilot randomised controlled trial aims to evaluate an intervention designed to help these families. The project tests an innovative service delivery model with interdisciplinary pain management being provided in face-to face workshops followed with Telehealth sessions delivered to the family home. The treatment team is led by a Physiotherapist and also includes an Occupational Therapist and Clinical Psychologist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45258 0
Ms Anna Hilyard
Address 45258 0
Physiotherapy Department
Princess Margaret Hopsital
Hay St
Subiaco
WA 6008
Country 45258 0
Australia
Phone 45258 0
+61 8 93408035
Fax 45258 0
Email 45258 0
[email protected]
Contact person for public queries
Name 45259 0
Ms Anna Hilyard
Address 45259 0
Physiotherapy Department
Princess Margaret Hopsital
Hay St
Subiaco
WA 6008
Country 45259 0
Australia
Phone 45259 0
+61 8 93408035
Fax 45259 0
Email 45259 0
[email protected]
Contact person for scientific queries
Name 45260 0
Ms Anna Hilyard
Address 45260 0
Physiotherapy Department
Princess Margaret Hopsital
Hay St
Subiaco
WA 6008
Country 45260 0
Australia
Phone 45260 0
+61 8 93408035
Fax 45260 0
Email 45260 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.