Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000803594
Ethics application status
Approved
Date submitted
7/07/2015
Date registered
3/08/2015
Date last updated
3/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Life Balance: A pilot study evaluating the efficacy of a group education program on self-management in older adults with multiple conditions.
Scientific title
A randomised wait-list control pilot study evaluating the efficacy of group self-management education sessions on quality of life in older persons with multi-morbidity.
Secondary ID [1] 287044 0
Nil
Universal Trial Number (UTN)
U1111-1171-9260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multi-morbidity 295518 0
Condition category
Condition code
Public Health 295811 295811 0 0
Health promotion/education
Mental Health 296000 296000 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four, two-hour weekly group-based education sessions. Sessions cover topics of self-management, values and goal setting, healthy living, symptom management, problem solving and introduces several mindfulness strategies aimed at assisting with worry and stress. Participants receive a 130 page resource book containing a synopsis of the content, further resources and self-directed exercises. The education sessions are presented by registered nurses, nurse practitioners, and a registered clinical psychologist.

Participants randomised to the intervention group will start the education programme one month after baseline questionnaire, while the control group will start the programme six weeks after the intervention group commenced the programme (waitlist control).
Intervention code [1] 292261 0
Lifestyle
Intervention code [2] 292429 0
Behaviour
Comparator / control treatment
Waitlist control group will be offered the intervention six weeks after the intervention group started the educational intervention.
Control group
Active

Outcomes
Primary outcome [1] 295489 0
Self-reported quality of life assessed by the SF-12
Timepoint [1] 295489 0
6 weeks after commencement of the intervention programme
Secondary outcome [1] 315691 0
Change in self-reported quality of life assessed via the SF-12
Timepoint [1] 315691 0
change from baseline to 12 weeks after commencement of the intervention programme
Secondary outcome [2] 315692 0
Disability assessed via the WHO Disability Assessment Schedule (WHODAS)
Timepoint [2] 315692 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [3] 316171 0
Medication adherence assessed by the Medication Adherence Questionnaire (MMAS-8)
Timepoint [3] 316171 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [4] 316172 0
Mindfulness capacity assessed via Mindful Attention Awareness Scale (MAAS)
Timepoint [4] 316172 0
baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [5] 316173 0
Beliefs about medication assessed via the Beliefs About Medicines Questionnaire (BMQ)
Timepoint [5] 316173 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [6] 316174 0
Illness Perception assessed via the Brief Illness Perception Questionnaire (BIPQ)
Timepoint [6] 316174 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [7] 316175 0
Health distress assessed by the Stanford Symptoms Health Distress Scale (SHD)
Timepoint [7] 316175 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [8] 316176 0
Depression assessed by the Stanford Personal Health Questionnaire Depression Scale (PHQ-8)
Timepoint [8] 316176 0
Baseline and 6 and 12 weeks after commencement of the intervention
Secondary outcome [9] 316177 0
Satisfaction with education sessions assessed by Satisfaction with Education Sessions patient satisfaction survey designed specifically for this study.
Timepoint [9] 316177 0
6 weeks after commencement of the intervention

Eligibility
Key inclusion criteria
Independently living older persons (non-Maori aged 65+ or Maori aged 55+) diagnosed with more than one long-term condition, able to attend and participate in the intervention sessions and to understand/speak English.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Currently being treated for an acute exacerbation (i.e. hospitalised).

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)
Sequentially numbered sealed opaque envelopes containing treatment allocation according to the randomisation schedule will be prepared. The envelopes will be kept by a person outside of the study team and only opened once a subject has provided informed consent, completed registration, and been allocated a study identification number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Wait list control. Those in the control group will start the intervention six weeks after the intervention group started the educational intervention. Both groups will provide further follow-up data 6 and 12 weeks after they have commenced the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participant characteristics at baseline will be reported using simple descriptive statistics. The primary outcome will be assessed using linear regression adjusting for baseline scores. The study design allows for estimation of within- and between-group effects. Therefore changes in continuous outcome measures over time, and differences between treatment groups, will be modelled using linear mixed models or general estimating equations. Parameter estimates with 95% confidence intervals will be derived from models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7021 0
New Zealand
State/province [1] 7021 0
Canterbury

Funding & Sponsors
Funding source category [1] 291599 0
Charities/Societies/Foundations
Name [1] 291599 0
Canterbury Medical Research Foundation
Country [1] 291599 0
New Zealand
Primary sponsor type
University
Name
Centre for Postgraduate Nursing Studies, University of Otago, Christchurch
Address
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 290270 0
Individual
Name [1] 290270 0
Dr Beverley Burrell
Address [1] 290270 0
Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [1] 290270 0
New Zealand
Other collaborator category [1] 278515 0
Individual
Name [1] 278515 0
Professor Marie Crowe
Address [1] 278515 0
Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [1] 278515 0
New Zealand
Other collaborator category [2] 278558 0
Individual
Name [2] 278558 0
Dr Jenny Jordan
Address [2] 278558 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [2] 278558 0
New Zealand
Other collaborator category [3] 278559 0
Individual
Name [3] 278559 0
Dr Virginia Jones
Address [3] 278559 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [3] 278559 0
New Zealand
Other collaborator category [4] 278560 0
Individual
Name [4] 278560 0
Dr Mandy Wilkinson
Address [4] 278560 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [4] 278560 0
New Zealand
Other collaborator category [5] 278561 0
Individual
Name [5] 278561 0
Ms Deb Gillon
Address [5] 278561 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [5] 278561 0
New Zealand
Other collaborator category [6] 278562 0
Individual
Name [6] 278562 0
Ms Shirley Harris
Address [6] 278562 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [6] 278562 0
New Zealand
Other collaborator category [7] 278563 0
Individual
Name [7] 278563 0
Dr Jonathan Williman
Address [7] 278563 0
C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country [7] 278563 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293130 0
Human Ethics Committee Research Ethics (Health)
Ethics committee address [1] 293130 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 293130 0
New Zealand
Date submitted for ethics approval [1] 293130 0
Approval date [1] 293130 0
29/01/2015
Ethics approval number [1] 293130 0
H15/003

Summary
Brief summary
New Zealand is experiencing an ageing population and the social, economic, medical and political implications and challenges that accompany demographic change. Overall, New Zealanders are living more independently and for longer, resulting in an ageing population with an increased prevalence of long-term conditions and often multiple conditions (multi-morbidity). It is increasingly acknowledged that ‘successful aging’ relies in part on the individual’s ability to self-manage his or her life. The concept of self-management or self-regulation has usually been associated with the physical aspects of aging but other factors are just as important for aging successfully including maintaining social networks and resources, and acquiring or maintaining skills to cope with potential and future stressors. Given the increased recognition of those factors and of the prevalence of multi-morbidity, current interventions are increasingly targeting overall wellbeing and utilising strategies that are useful for trans-diagnostic (across multiplie diseases) symptoms rather than a symptom /disease specific approach. Mindfulness strategies offer potential to enhance self-management and quality of life across physical conditions.
The Life Balance Self-management Programme being evaluated here combines cognitive behavioural and mindfulness strategies, applying them across chronic diseases (trans-diagnostically) to help manage negative thoughts and emotions and to enhance the uptake of the education and self-management strategies.
This randomised pilot study aims to test that participant recruitment and randomisation to groups, education sessions and data gathering via questionnaires run smoothly and to produce data from the outcomes of the education sessions to support undertaking a larger randomised controlled trial.
The study design is a randomised open-label controlled trial with a wait listed control group. A convenience sample will be recruited of 60 older adults (non-Maori aged 65+ or Maori aged 55+) living independently in the community diagnosed with one or more long-term conditions and able to attend and participate in the intervention sessions and to understand/speak English.
The Life Balance Self-management Programme entails attendance at 2 hour group education sessions for four consecutive weeks (8hrs in total). Manualised education sessions include the following topics: Healthy living, Symptom management, medication management and Self-management, form the first hour each day and four sessions on Mindful coping skills (cognitive behavioural and mindfulness strategies) are presented in the second hour. Participants receive a 130 page resource book containing a synopsis of the content, further resources and self-directed exercises.
Outcomes measures assessed at baseline, 6 weeks and 12 weeks include the primary outcome (quality of life) as well as measures assessing disability, medication adherence, mindfulness awareness, beliefs about medication, illness perception, health distress, depression and satisfaction with education sessions at end treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58610 0
Dr Beverley Burrell
Address 58610 0
Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 58610 0
New Zealand
Phone 58610 0
+64 3 364 3850
Fax 58610 0
Email 58610 0
[email protected]
Contact person for public queries
Name 58611 0
Dr Beverley Burrell
Address 58611 0
Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 58611 0
New Zealand
Phone 58611 0
+64 3 364 3850
Fax 58611 0
Email 58611 0
[email protected]
Contact person for scientific queries
Name 58612 0
Dr Beverley Burrell
Address 58612 0
Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140
Country 58612 0
New Zealand
Phone 58612 0
+64 3 364 3850
Fax 58612 0
Email 58612 0
[email protected]

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