Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001034921
Ethics application status
Approved
Date submitted
28/09/2011
Date registered
29/09/2011
Date last updated
23/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Managing Chronic Obstructive Pulmonary Disease
(COPD)Together: Participant-CENTREd Continuum of Care (PCCC). A comparison of telephone health-mentoring, home-based walking and rehabilitation with rehabilitation only.
Scientific title
A randomised controlled clinical trial in adults with Chronic Obstructive Pulmonary Disease on the effect of
telephone health-mentoring, home-based walking and
rehabilitation compared with rehabilitation only on health-related quality of life.
Secondary ID [1] 262786 0
Not applicable
Universal Trial Number (UTN)
Not applicable
Trial acronym
PCCC COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 270493 0
Condition category
Condition code
Respiratory 270651 270651 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 270652 270652 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (Rehab-plus) comprises telephone health-mentoring with a home-based walking action plan plus pulmonary rehabilitation.
1. Rehab-Plus participants will establish a 'SNAPPS' (Smoking, Nutrition, Alcohol, Physical activity, Psychosocial wellbeing, Symptom management) Health Behaviours Summary and Profile and set a home-based walking plan with the Research Assistant. They will receive a ‘Participant Pack’ containing:
-A copy of their walking plan and additional blank forms
-A copy of their 'SNAPPS' Health Behaviours Summary and Profile
-‘ SNAPPS’ Health Behaviours Choices and Guidelines table
-Exercise, Nutrition, Living with COPD pamphlets
-Dealing with your concerns flowchart.
2. Rehab-Plus participants will be contacted via telephone by a community nurse health-mentor over 6 to 12 weeks, to support the walking plan, and other health-behaviour plans. They will be notified when pulmonary rehabilitation is to commence.
We suggest the initial two calls be weekly: the first call is to establish contact, review and reset the home-walking action plan and agree on any other actions. The second call one week later is to reinforce the commitment to working together and to support the home-walking plan and other agreed actions. We have found in clinical practice that most prefer a call a week after the initial contact. Our clinical experience and our pilot research that investigated telephone-delivered mentoring found that nurses and participants did not strictly adhere to an ongoing prescribed regime of telephone calls. Rather, the frequency and duration of calls was negotiated between the nurse and participant, according to individual needs. Therefore, we also suggest as a guide a minimum of four calls be made over the 6 to 12 week health-mentoring period to support the walking plan and other health-behaviour changes.
NOTE:
1. Community Nurses will be trained in self-management support under the 'CENTREd' Model (Commitment to partnership, Engagement and establishihg and agreed agenda, Negotiation of mutally identified goals, Taking action to achieve the goals, Repeating back key information to ensure mutual understanding, Establishing planned follow-up to develop a proactive approach to care).

2. Pulmonary rehabilitation consists of individual management of issues such as airway clearance techniques; six-week group-based Stanford Chronic Disease Self-Management Program; two sessions specifically addressing (a) exercise and home-based walking action plan, (b) medication use and other group-identified issues; and optional weekly group-based supervised exercise.

3. Supervised exercise:
- Frequency - 1 session per week
- Intensity - the intensity of exercise is determined by using the modified Borg Rating of Perceived Exertion (RPE) Scale, aiming for a minimum of moderate intensity (RPE = 3) and not exceeding a strong intensity (RPE = 5).
- Time (duration of exercise session) - 1 hour
- Type - This general guideline is adjusted according to individual needs: 5 minutes of warm-up exercises, 30 minutes of aerobic exercise (bicycle , treadmill, corridor walking, bicycle arm pedals), 5 minutes of stretching exercise (upper limb, lower limb, and trunk), 10 minutes of strengthening exercise (upper limb, lower limb, trunk with free weights, pulleys, steps, elastic bands, or fit ball), 5 minutes of cool-down exercises.
- Mode - Participants attend in a group, with each individual progressing according to their response to exercise. Exercise sessions are supervised by a trained physiotherapy assistant, with the physiotherapist readily available for consultation if needed.

4. The Chronic Disease Self-Management Program is a highly structured group-based 6-week workshop with sessions of 2 and a 1/2 hours duration offered once per week and facilitated by pairs of trained leaders.The leaders may be peers (others with a chronic condition) or health professionals who have undertaken 24 hours of training. It offers generic education about health-related behaviours: symptom management (anger, fear, frustration, depression, shortness of breath, fatigue, pain); breathing exercises; muscle relaxation; endurance exercise; cognitive symptom management; communication skills; advance directives for health care; working with and informing the healthcare team; medication usage and healthy eating. The CDSMP aims to facilitate the development of self-management self-efficacy (akin to confidence) through guided feedback sessions, problem-solving and completing action plans to achieve participant-defined goals. There is no supervised exercise component.
Intervention code [1] 269131 0
Rehabilitation
Intervention code [2] 269132 0
Behaviour
Comparator / control treatment
The control consists of pulmonary rehabilitation alone (Rehab-only).
Participants in both groups attend the same standard pulmonary rehabilitation described under 'Description of Intervention).
Control group
Active

Outcomes
Primary outcome [1] 279686 0
Physical capacity, measured by the distance walked in the 6 Minute Walk Test.
Timepoint [1] 279686 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [1] 294213 0
Home-based walking measured by accelerometer.
Timepoint [1] 294213 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [2] 294214 0
Health-related behaviours measured by the 'SNAPPS' Snapshot 8-item tool.
Timepoint [2] 294214 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [3] 294215 0
Health-Related Quality of Life measured by the COPD Assessment Test
Timepoint [3] 294215 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [4] 294216 0
Hospital readmissions measured by the number of admissions during the study
Timepoint [4] 294216 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [5] 294217 0
Working in partnership measured by the 'Working in Partnership' tool
Timepoint [5] 294217 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [6] 294218 0
Experience of Rehab-Plus or Rehab-Only measured by 'Your Experiences? questionnaire
Timepoint [6] 294218 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).
Secondary outcome [7] 294219 0
Nurse health-mentor experience 'Working in Partnership' and 'Your Experiences' questionnaire
Timepoint [7] 294219 0
Timepoint One: Baseline
Timepoint Two: Pre-rehabilitation (measured 8 weeks after
baseline measure).
Timepoint Three: Post-rehabilitation (no more than 2 weeks post).

Eligibility
Key inclusion criteria
Participants are eligible if they:
- are over 18 years
- have a diagnosis COPD based on spirometry
- are willing and able to commit to telephone follow-up
- are referred to cardiopulmonary rehabilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants are ineligible if they
- have an intellectual disability
- are unable to provide informed consent
- are unable to complete a self-administered questionnaire
- unable to safely undertake an exercise programme due to the presence of any one of the following conditions: uncontrolled cardiac conditions (resting systolic blood pressure > 180mm mercury and/or resting diastolic blood pressure > 110mm mercury, resting heart rate >120 beats per minute, unstable angina, severe cardiac valve disease, uncontrolled atrial or ventricular arrhythmias, uncompensated chronic heart failure, active pericarditis or myocarditis); recent vascular conditions (recent embolism or thrombophlebitis, active retinal haemorrhage, recent cerebrovascular accident); uncontrolled metabolic disorder (uncontrolled diabetes, retinopathy, acute thyroiditis, uncontrolled liver or renal disease, active cancer); severe orthopaedic problems; acute systemic illness or fever(Balady 2000).

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)
The Research Assistant will screen participants following hospital admission, a clinic visit or private
practitioner referral to physiotherapy cardiorespiratory outpatients for COPD management or following an exacerbation. Standard hospital data will be used to confirm study suitability (age, diagnosis, co-morbidities including safety to exercise).

The Research Assistant will approach potential participants meeting the screening criteria by telephone, outline the project and possible benefits, answer any questions and make an appointment to seek signed informed consent and obtain baseline measures. Those not meeting the inclusion criteria or declining to take part will be referred to physiotherapy cardiorespiratory outpatients in accordance with usual practice. Those declining to participate will be invited to complete a check-list of possible reasons should they choose to do so.

Participants will be allocated to the intervention or control arms by consecutive randomisation, using computer-generated random numbers. Allocation concealment will be achieved by using opaque sealed envelopes and allocating after consenting and completing baseline assessment. The recruiter and data analyst will be blinded to allocation during the baseline data collection and analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to the intervention or control arms by consecutive randomisation, using computer-generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The two other sites were unable to participate therefore the trial continued with one centre and the primary outcome and power calculations were revised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
15/02/2012
Actual
15/02/2012
Date of last participant enrolment
Anticipated
29/11/2013
Actual
8/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269923 0
University
Name [1] 269923 0
Menzies Research Institute Tasmania, University of Tasmania
Country [1] 269923 0
Australia
Funding source category [2] 269924 0
Charities/Societies/Foundations
Name [2] 269924 0
Royal Hobart Hospital Research Foundation
Country [2] 269924 0
Australia
Funding source category [3] 269928 0
Government body
Name [3] 269928 0
Department of Health and Human Services
Country [3] 269928 0
Australia
Funding source category [4] 289283 0
University
Name [4] 289283 0
University of Tasmania
Country [4] 289283 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute Tasmania, University of Tasmania
Address
Private Bag 23
Hobart TAS 7000
Country
Australia
Secondary sponsor category [1] 268929 0
Hospital
Name [1] 268929 0
Royal Hobart Hospital
Address [1] 268929 0
Address: GPO Box 1061,
Hobart,
Tasmania. 7001
Country [1] 268929 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271895 0
Human Research Ethics Committee (Tasmania)
Ethics committee address [1] 271895 0
Ethics committee country [1] 271895 0
Australia
Date submitted for ethics approval [1] 271895 0
Approval date [1] 271895 0
11/07/2011
Ethics approval number [1] 271895 0
H11764

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

Contacts
Principal investigator
Name 32981 0
Dr Helen Cameron-Tucker
Address 32981 0
Menzies Research Institute Tasmania, Private Bag 23 Hobart TAS 7000
Country 32981 0
Australia
Phone 32981 0
+61-3-6226 4893
Fax 32981 0
Email 32981 0
[email protected]
Contact person for public queries
Name 16228 0
Helen Cameron-Tucker
Address 16228 0
Menzies Research Institute Tasmania,
Private Bag 23
Hobart TAS 7000
Country 16228 0
Australia
Phone 16228 0
+61-3-6226 4893
Fax 16228 0
Email 16228 0
[email protected]
Contact person for scientific queries
Name 7156 0
Helen Cameron-Tucker
Address 7156 0
Menzies Research Institute Tasmania,
Private Bag 23
Hobart TAS 7000
Country 7156 0
Australia
Phone 7156 0
+61-3-6226 4893
Fax 7156 0
Email 7156 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

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