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Trial registered on ANZCTR


Registration number
ACTRN12614001085662
Ethics application status
Approved
Date submitted
17/09/2014
Date registered
10/10/2014
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Date results provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the mental health of adults with diabetes: A study of an Optimal Health Program (OHP)
Scientific title
Randomised controlled trial to evaluate the impact of Optimal Health Program on the mental health of adults with diabetes
Secondary ID [1] 284877 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
This project is part of the broader research program Translating Research, Integrated Public Health Outcomes and Delivery (TRIPOD).
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health
 292313 0
Type I Diabetes 293122 0
Type II Diabetes 295962 0
Condition category
Condition code
Mental Health 292650 292650 0 0
Depression
Mental Health 292651 292651 0 0
Anxiety
Metabolic and Endocrine 292652 292652 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The self-management (Optimal Health) program will utilise the Collaborative Therapy Framework delivered by an OHP facilitator. This program is composed of three core components adapted to suit the specific needs of the adult with type I or type II diabetes. This is part of a larger program of larger research study known as the Translational Research, Integrated Public Health Outcomes and Delivery (TRIPOD). TRIPOD is a collaborative effort between three research projects aimed at understanding the efficacy and impact OHP has on the wellbeing of people with specific chronic health problems and their carers. The study of OHP in carers of stroke survivors has been previously registered as a trial (ACTRN12613000064707.)

a) The OHP framework utilises a modular format. Each module encompasses a manualised discrete skill development intervention run over 8 weeks (plus booster session) involving: health promotion, interagency collaboration, accessible support care coordinator, information about diabetes and resources, understanding stress, family and community support and living with diabetes including adjustment to diagnosis and self-management of blood sugar and lifestyle targets. The modular format allows for tailoring of the intervention to suit the needs of adults with type I or type II diabetes at various stages of the illness. Similarity across modules in terms of the core intervention, plus overlap between modules, enhances implementation through familiarity with the methods and style. This also addresses efficiency and cost-effectiveness with respect to training staff. Each session is designed to build on the learnings from the previous session with the ‘I Can Do model’ as the core theme. It is one of the unique components of the Optimal Health Program.
b) Self-efficacy is a pivotal part of the process and is taught using a systematic approach to both clinicians and consumers with each module, regardless of content, delivers education, coping strategies, skills development and adaptation paradigms. This supports the philosophy that a person’s illness should not be ‘dependent on’ but ‘supported by’ the services they need to utilise.
c) Smooth integration through acute and community services is paramount. Therapeutic and systemic collaboration with consumers and clinicians will be an integral part of the process.

Based on the pilot study data, literature, and anecdotal experience the OHP used in the RCT phase 'Mental Health in Diabetes Optimal Health Program' (MINDS OHP) will be specifically tailored to people with diabetes. The MINDS OHP facilitator will draw on diabetes-specific information in concordance with the multidisciplinary team, for example information on the relationship between stress and hypoglycaemia, availability of diabetes supports in the community, and coping strategies for addressing anxiety related to self-management.

MINDS OHP sessions will be conducted 1 hour per week for 8 weeks. There may be some unavoidable variation depending on participant circumstances (e.g. ill health may lead to longer break between sessions). Sessions will be conducted one-to-one and sessions are facilitated by a trained OHP facilitator. A single booster session will be conducted with participants 3 months post completion of intervention. The booster session is also one hour duration and the overall theme for this session is to address 'what is my health like now' for participants. This booster session will involve review of health plans 1, 2, and 3, consolidation of progress and reflection on achievements towards health-related goals.

Two post-intervention focus groups for patients and clinician participants (nurses, physicians, allied health workers) will also be run to assist in the evaluation of MINDS OHP.
Focus groups will be 1 hour duration and dual moderated by a senior member of the investigator team and a student researcher. Post intervention focus groups with clinicians and participants in the RCT will be conducted 3 months after the intervention phase of the trial. Focus groups with OHP participants will be conducted by members of the research team who are not OHP facilitators.

OHP facilitators will receive training, and regular weekly supervision to discuss problems and minimise non-standardised activity. In addition, thematic issues will be raised at supervision meetings. OHP faciliators will also maintain session notes and attendance records for each participant to assist with supervision and monitoring of adherence to OHP protocol.
Intervention code [1] 289685 0
Prevention
Intervention code [2] 289686 0
Lifestyle
Intervention code [3] 289687 0
Behaviour
Comparator / control treatment
For patients recruited from St. Vincent's Hospital:
Standard care as provided by the multidisciplinary diabetes teams in St Vincent’s Hospital

For patients recruited through external sites including the Royal Victorian Eye and ear Hospital and through advertisement in community organisations (e.g. Diabetes Australia VIC, HypoActive)
Standard care will be assessed through participant responses on the Health Care Utilisation Questionnaire
Control group
Active

Outcomes
Primary outcome [1] 292492 0
Assessment of Quality of Life (AQoL 6D)
Timepoint [1] 292492 0
baseline, 3 months, 6 months, and 12 months after randomisation.
Primary outcome [2] 292493 0
General Self-Efficacy Scale
Timepoint [2] 292493 0
baseline, 3 months, 6 months, and 12 months after randomisation.
Secondary outcome [1] 309093 0
Self-efficacy scores on the Diabetes Empowerment Scale
Timepoint [1] 309093 0
baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [2] 309094 0
Quality of Life scores on the EuroQoL EQ-5D-3L and Diabetes Quality of Life Brief Clinical Inventory
Timepoint [2] 309094 0
baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [3] 309095 0
Personality as measured by scores on the Big 5 Inventory - 10-item version
Timepoint [3] 309095 0
baseline
Secondary outcome [4] 309096 0
Scores on the Brief COPE (coping styles)
Timepoint [4] 309096 0
baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [5] 309097 0
scores on the Alcohol, Smoking and Substance Involvement Screening Test
Timepoint [5] 309097 0
baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [6] 309098 0
scores in the Brief Illness Perception questionnaire
Timepoint [6] 309098 0
baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [7] 309099 0
Body Mass Index as taken from the medical record
Timepoint [7] 309099 0
Baseline, 3 months, 6 months, and 12 months after randomisation
Secondary outcome [8] 310432 0
Scores on the credibility/expectancy questionnaire
Timepoint [8] 310432 0
Completed once only following the first MINDS OHP session
Secondary outcome [9] 310433 0
Scores on the Treatment Evaluation Inventory - Short Form
Timepoint [9] 310433 0
3 months
Secondary outcome [10] 310434 0
Economic evaluation - scores on the AQoL 6D, EQ-5D-3L, and the Health Utilisation Questionnaire (HUQ).
Information on costs will be captured in the Health Utilisation questionnaire. This includes medical and non-medical (e.g. transportation) costs ($) of hospital, GP, and mental health clinician visits. The HUQ also captures information about relative costs covered by participants and costs covered by rebates.
Timepoint [10] 310434 0
baseline, 3, 6, and 12 months post randomisation.
Utility and cost questionnaires and an economic evaluation will be conducted at each of these time points.
Secondary outcome [11] 316888 0
Hospital Anxiety and Depression Scale
Timepoint [11] 316888 0
baseline, 3 months, 6 months, 12 months post-randomisation
Secondary outcome [12] 316889 0
Diabetes-Related Distress as measured by Problem Areas in Diabetes scale
Timepoint [12] 316889 0
baseline, 3 months, 6 months, 12 months post-randomisation
Secondary outcome [13] 316890 0
Functional impairment as measured by the Work and Social Adjustment Scale
Timepoint [13] 316890 0
baseline, 3 months, 6 months, 12 months post-randomisation
Secondary outcome [14] 316891 0
HbA1c (average glycaemia over the preceding 6–8 weeks) as taken from the medical record.
Timepoint [14] 316891 0
baseline, 3 months, 6 months, 12 months post-randomisation
Secondary outcome [15] 316892 0
standard care utilization, assessed by the Healthcare Utilisation Questionnaire in control and intervention groups
Timepoint [15] 316892 0
baseline, 3 months, 6 months, 12 months post-randomisation

Eligibility
Key inclusion criteria
Patients aged 18 years and older with a diagnosis of type I diabetes or type II diabetes and able to converse in English without an interpreter.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are 1) non-English speaking and 2) unable to consent.

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)
A simple randomisation of equal number of subjects to treatment and control groups will be conducted. Patients will be informed of the study by a research clinician working in conjuction with the diabetes team. Patients will also be recruited through community advertisement of the OHP (e.g., through Diabetes Australia - VIC website and events, HypoActive) and provided with contact details to obtain further information about the study and ask questions.

Patients will be approached for consent and if agreeing to participate and meet inclusion criteria, will be randomised by computer generated number system to either treatment or control condition. Allocation will be concealed via method of central randomisation via computer. Consenting participants will be randomly assigned via block randomisation computerised sequence to be treated in either the intervention group, or the control group which will receive the MINDS Optimal Health Program (OHP) at the end of 12 months. The decision to assign will not be up to any clinician or researcher but rather a computer programme that will select numbers at random. The intervention group will receive the OHP comprising eight 1 hour sessions (and a booster session). For control and intervention group participants, three, six, and 12 month followup appointments will occur during which participants will complete a questionnaire.

CONSORT procedures will be followed: assessors will be blind to intervention allocation and intention-to-treat analyses will be applied. The allocation sequence will be generated using random numbers. Patients will be randomised progressively as they are consented and complete baseline assessment.

Due to the variability of standard care, all participants will complete the Health Utilisation Questionnaire at baseline, 3, 6 and 12 month follow-up points to map key aspects of standard care at each unit of each site.

Assessors and OHP facilitators will receive training, and regular supervision to discuss problems and minimise non-standard activity.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Intention-to-treat analysis will be employed to prevent over-estimation of efficacy. Categorical variables will be analysed using chi-squared tests (or Fisher’s exact test for small samples). A mixed-effects model, repeated measures (MMRM) approach will be used to examine the longitudinal profile of all continuous variables at months 3, 6, and 12 post-baseline. For all MMRM analyses, baseline scores will be used as covariates and the models will include pre-specified fixed effects of treatment, clinician, and time, and treatment-by-time and treatment-by-clinician interactions.
Secondary analyses using Analysis of Covariance will be conducted to compare change scores during treatment and follow-up phases for all primary, secondary, and process outcomes using the fixed, continuous covariate of baseline score as well as the categorical fixed effects of treatment group, clinician, and treatment-by-clinician interactions.
Sample size: Power was calculated to detect a medium effect size of d = 0.50. This was chosen as a clinically meaningful domain that may be compared with previous RCT research in this area of chronic disease management programs. The calculations followed the method described by Diggle et al. (2002) and assumed two primary outcomes (AQOL-6D and GSES scores), four assessment points (baseline, 3-month, 6-month, and 12-month follow-ups), a study-wide Type I error rate (a) of .05, and hence a Type II error rate (beta) of .20 (power of .80), a correlation of post-treatment scores with baseline measurements of 0.81, and a two-tailed statistical test. To detect the effect size of d = 0.50, 66 participants in each of the control and intervention groups will be required. Allowing for up to 20% attrition, a total of 166 participants, or 83 in each group will be recruited.
Attrition and missing data: Although the attrition rate is not expected to vary by treatment condition, we will attempt to identify key predictors of attrition status (i.e., demographic and baseline clinical characteristics) and test for differences between conditions. Assuming the data are missing at random, several procedures offer effective approaches that may attenuate attrition. Maximum likelihood models (i.e., MMRM), with time as a random variable, allow the use of all available data from all assessments, reducing bias and increasing power (Nich & Carroll, 1997). In addition, multiple imputation procedures that utilise the expectation-maximization (EM) algorithm with bootstrap estimates of standard errors will be used to address attrition. The application of these procedures can provide unbiased estimates, even in the face of substantial missing data (Schafer & Donaldson, 2002).

Diggle, P.J., Heagerty, P.J., Liang, K., & Zeger, S.L.. (2002). Analysis of longitudinal data (2e). Oxford Statistical Science Series.
Nich, C., & Carroll, K. (1997). Now you see it, now you don't: a comparison of traditional versus random-effects regression models in the analysis of longitudinal follow-up data from a clinical trial. Journal of Consulting and Clinical Psychology, 65(2), 252.
Schafer, J. L., & Graham, J. W. (2002). Missing data: our view of the state of the art. Psychological methods, 7(2), 147.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2015
Actual
6/05/2015
Date of last participant enrolment
Anticipated
30/12/2016
Actual
23/06/2017
Date of last data collection
Anticipated
31/10/2018
Actual
17/09/2018
Sample size
Target
166
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4809 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [2] 4810 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 8375 0
3065 - Fitzroy
Recruitment postcode(s) [2] 12315 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 289499 0
Government body
Name [1] 289499 0
This project is supported through the Australian Government’s Collaborative Research Networks (CRN) program
Country [1] 289499 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital
Address
P.O.Box 2900 Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 288183 0
University
Name [1] 288183 0
Australian Catholic University
Address [1] 288183 0
115 Victoria Parade
Fitzroy VIC 3065
Country [1] 288183 0
Australia
Other collaborator category [1] 278021 0
Hospital
Name [1] 278021 0
Cardiovascular Research Centre, St. Vincent's Hospital
Address [1] 278021 0
P.O.Box 2900 Fitzroy VIC 3065
Country [1] 278021 0
Australia
Other collaborator category [2] 278022 0
University
Name [2] 278022 0
The University of Melbourne
Address [2] 278022 0
Department of Psychiatry
The University of Melbourne
Level 1 North, Main Block
Royal Melbourne Hospital VIC 3050 Australia
Country [2] 278022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291651 0
St. Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 291651 0
Ethics committee country [1] 291651 0
Australia
Date submitted for ethics approval [1] 291651 0
07/04/2015
Approval date [1] 291651 0
21/04/2015
Ethics approval number [1] 291651 0
HREC-A 036/14
Ethics committee name [2] 293952 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [2] 293952 0
Ethics committee country [2] 293952 0
Australia
Date submitted for ethics approval [2] 293952 0
09/09/2015
Approval date [2] 293952 0
13/10/2015
Ethics approval number [2] 293952 0
15/1243H

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

Contacts
Principal investigator
Name 49502 0
Prof David Castle
Address 49502 0
St. Vincent's Mental Health
P.O. Box 2900
Fitzroy VIC Australia 3065
Country 49502 0
Australia
Phone 49502 0
+61 3 9231 4751
Fax 49502 0
+61 3 9231 4147
Email 49502 0
[email protected]
Contact person for public queries
Name 49503 0
David Castle
Address 49503 0
St. Vincent's Mental Health
P.O. Box 2900
Fitzroy VIC Australia 3065
Country 49503 0
Australia
Phone 49503 0
+61 3 9231 4751
Fax 49503 0
Email 49503 0
[email protected]
Contact person for scientific queries
Name 49504 0
David Castle
Address 49504 0
St. Vincent's Mental Health
P.O. Box 2900
Fitzroy VIC Australia 3065
Country 49504 0
Australia
Phone 49504 0
+61 3 9231 4751
Fax 49504 0
Email 49504 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Access to de-identified data from the database may be provided upon reasonable request from the principal investigator.


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
SourceTitleYear of PublicationDOI
EmbaseThe Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: Study protocol for a randomized controlled trial.2016https://dx.doi.org/10.1186/s13063-016-1561-4
N.B. These documents automatically identified may not have been verified by the study sponsor.