ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1171-9260

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multi-morbidity

Condition category

Condition code

Public Health

Health promotion/education

Mental Health

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]

Lifestyle

Intervention code [2]

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]

Self-reported quality of life assessed by the SF-12

Timepoint [1]

6 weeks after commencement of the intervention programme

Secondary outcome [1]

Change in self-reported quality of life assessed via the SF-12

Timepoint [1]

change from baseline to 12 weeks after commencement of the intervention programme

Secondary outcome [2]

Disability assessed via the WHO Disability Assessment Schedule (WHODAS)

Timepoint [2]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [3]

Medication adherence assessed by the Medication Adherence Questionnaire (MMAS-8)

Timepoint [3]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [4]

Mindfulness capacity assessed via Mindful Attention Awareness Scale (MAAS)

Timepoint [4]

baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [5]

Beliefs about medication assessed via the Beliefs About Medicines Questionnaire (BMQ)

Timepoint [5]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [6]

Illness Perception assessed via the Brief Illness Perception Questionnaire (BIPQ)

Timepoint [6]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [7]

Health distress assessed by the Stanford Symptoms Health Distress Scale (SHD)

Timepoint [7]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [8]

Depression assessed by the Stanford Personal Health Questionnaire Depression Scale (PHQ-8)

Timepoint [8]

Baseline and 6 and 12 weeks after commencement of the intervention

Secondary outcome [9]

Satisfaction with education sessions assessed by Satisfaction with Education Sessions patient satisfaction survey designed specifically for this study.

Timepoint [9]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Canterbury Medical Research Foundation

Address [1]

PO Box 3225
Christchurch 8011

Country [1]

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]

Individual

Name [1]

Dr Beverley Burrell

Address [1]

Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Professor Marie Crowe

Address [1]

Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Dr Jenny Jordan

Address [2]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [2]

New Zealand

Other collaborator category [3]

Individual

Name [3]

Dr Virginia Jones

Address [3]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [3]

New Zealand

Other collaborator category [4]

Individual

Name [4]

Dr Mandy Wilkinson

Address [4]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [4]

New Zealand

Other collaborator category [5]

Individual

Name [5]

Ms Deb Gillon

Address [5]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [5]

New Zealand

Other collaborator category [6]

Individual

Name [6]

Ms Shirley Harris

Address [6]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [6]

New Zealand

Other collaborator category [7]

Individual

Name [7]

Dr Jonathan Williman

Address [7]

C/- Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country [7]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Ethics Committee Research Ethics (Health)

Ethics committee address [1]

University of Otago
PO Box 56 
Dunedin 9054

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

29/01/2015

Ethics approval number [1]

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

Dr Beverley Burrell

Address

Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 3850

Fax

beverley.burrell@otago.ac.nz

Contact person for public queries

Name

Beverley Burrell

Address

Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 3850

Fax

beverley.burrell@otago.ac.nz

Contact person for scientific queries

Name

Beverley Burrell

Address

Centre for Postgraduate Nursing Studies
University of Otago, Christchurch
PO Box 4345
Christchurch 8140

Country

New Zealand

Phone

+64 3 364 3850

Fax

beverley.burrell@otago.ac.nz

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference poster	No		https://cag.conference-services.net/reports/templa... [More Details]	368888-(Uploaded-21-11-2018-14-29-42)-Other results publication.docx

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No additional documents have been identified.

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