Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000827134
Ethics application status
Approved
Date submitted
24/05/2019
Date registered
7/06/2019
Date last updated
5/11/2020
Date data sharing statement initially provided
7/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telephone-delivered adherence therapy for adults with type 2 diabetes: a feasibility study
Scientific title
Telephone-delivered adherence therapy for adults with type 2 diabetes: a feasibility study
Secondary ID [1] 298225 0
None
Universal Trial Number (UTN)
U1111-1233-6390
Trial acronym
ATT2D (Adherence Therapy for patients with Type 2 Diabetes)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 312826 0
Condition category
Condition code
Metabolic and Endocrine 311326 311326 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adherence therapy (AT) is a brief psychological intervention based on the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT). AT is a patient-centred approach delivered by a trained clinician over a series of 8 sessions weekly. Each session will take about half an hour. Key therapy techniques include adherence assessment (session 1) medication problem solving (session 2 and 3), exchanging information (session 4), exploring ambivalence (session 5 and 6), and challenging beliefs (session 7 and 8). Theoretically, these techniques amplify the personally relevant benefits of treatment, modify illness and treatment beliefs, and resolve ambivalence towards taking medication. The intervention will be delivered over the telephone. Treatment fidelity will be checked by an independent rater against an AT scale using audio recordings of a random selection of sessions (approximately 4).
Intervention code [1] 314469 0
Behaviour
Comparator / control treatment
Participants in the control and experimental group will continue receiving their usual care. Treatment as usual for adults with type two diabetes includes regular doctor visits and meetings with the health educator if referred by the doctor. Meetings with the diabetes educator include reviewing patient’s glycaemic control tests, glucose monitoring, and a didactic educational session.
Control group
Active

Outcomes
Primary outcome [1] 320056 0
The number of patients that need to be asked to get one to provide written informed consent. Data will be extracted from study records.
Timepoint [1] 320056 0
Two days after receiving the participant information sheet and informed consent.
Primary outcome [2] 320116 0
The number of participants who complete the therapy.
Data will be extracted from study records.
Timepoint [2] 320116 0
Eight weeks after the first day of the therapy.
Primary outcome [3] 320117 0
The number of participants who complete the baseline and follow up assessments.
Data will be extracted from study records.
Timepoint [3] 320117 0
Baseline assessments: within two weeks of participants giving consent.
Follow-up assessments: nine weeks after completion of the baseline assessments.
Secondary outcome [1] 370382 0
The number of patients asked about taking part in the study who express interest and request participant information sheet.
Data will be extracted from study records.
Timepoint [1] 370382 0
In the first week when patients are approached about participating in the study.
Secondary outcome [2] 370661 0
The number of patients who meet the inclusion criteria.
Data will be extracted from study records.
Timepoint [2] 370661 0
In order to determine if participants are non-adherent and meet study inclusion criteria, subjects will be asked to complete the Medication Adherence Rating Scale at the screening visit. We will only include non-adherent patients (defined as a Medication Adherence Rating Scale score less than or equal to 5).
Secondary outcome [3] 370662 0
Adherence determined using the Medication Adherence Rating Scale.
Timepoint [3] 370662 0
At baseline and weeks nine after completion of treatment.
Secondary outcome [4] 370663 0
Patient beliefs about medication will be determined using the Beliefs about medication Questionnaire.
Timepoint [4] 370663 0
At baseline and weeks nine after completion of treatment.

Eligibility
Key inclusion criteria
• Adults aged 18 and over
• Diagnosed with type two diabetes for at least 1 year.
• Prescribed with a combination of diabetes medications
• Non-adherent according to medication adherence rating (score<=7)
• Participants that have access to a telephone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

• Participating in other clinical trials
• Currently receiving any other psychological or psychosocial intervention
• Patients with a terminal illness, brain injury, psychosis, dementia, cognitive impairment, or memory problem as these conditions might make it difficult for patients to engage in treatment.
• Hearing impaired, as the program is delivered via phone and required the participants to communicate verbally.

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)
We will use sealedenvelope.com to randomize participants. This is a third party randomization service that is independent of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence generation. Permuted blocks of between 4, 6 and 8.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will use descriptive statistics to summarise the number and proportion of patients who complete each point of the trial. Summary statistics (means, proportions, 95% confidence intervals) will be tabulated for outcome variables but we do not intend to undertake any form of statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
1/07/2020
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
20
Accrual to date
7
Final
Recruitment outside Australia
Country [1] 21475 0
Saudi Arabia
State/province [1] 21475 0
Riyadh

Funding & Sponsors
Funding source category [1] 302766 0
Government body
Name [1] 302766 0
Saudi Arabian Cultural Mission
Country [1] 302766 0
Saudi Arabia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty R0ad and Kingsbury Drive Bundoora VICTORIA 3086
Country
Australia
Secondary sponsor category [1] 302705 0
Hospital
Name [1] 302705 0
National Guard Health Affairs Hospital
Address [1] 302705 0
Ar Rimayah, Riyadh 14611, Saudi Arabia
Country [1] 302705 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303363 0
La Trobe University Human Research Ethics Committee (HREC)
Ethics committee address [1] 303363 0
La Trobe University, Science Drive, Bundoora VICTORIA 3083
Building: David Myers East, Level 2, 224
Ethics committee country [1] 303363 0
Australia
Date submitted for ethics approval [1] 303363 0
16/05/2019
Approval date [1] 303363 0
27/06/2019
Ethics approval number [1] 303363 0

Summary
Brief summary
Type two diabetes is one of the fastest growing chronic diseases worldwide. Patients with type 2 diabetes must be committed to a daily routine to avoid diabetes complications. One of the problems they face is poor medication adherence. In this study we will test the feasability of Adherence Therapy which aims to help people to manage their medication more effectively. The therapy has not been tested among these patients. The objective of this study is to establish the feasibility of conducting Adherence Therapy in the Middle Eastern context.

This is a randomized and unblinded study that aims to establish the feasibility of conducting Adherence Therapy in the Middle Eastern context.
We aim to recruit 40 patients with diabetes. Patients who meet the eligibility criteria and provide consent will be randomly assigned into treatment as usual or Adherence Therapy.

Randomization will be via the sealed envelope website (www.sealedenvelope.com). The online randomization website generates random allocation sequence. To prevent selection bias, randomization will take place after the baseline measures have been completed. Allocation won’t be concealed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93410 0
Prof Richard Gray
Address 93410 0
La Trobe University
Plenty Rd & Kingsbury Dr,
George Singer Building, Level 3,
Bundoora, VIC 3086
Country 93410 0
Australia
Phone 93410 0
+61 (0)481248182
Fax 93410 0
Email 93410 0
[email protected]
Contact person for public queries
Name 93411 0
Mrs Fatimah Alenazi
Address 93411 0
La Trobe University
Plenty Rd & Kingsbury Dr,
George Singer Building, Level 3,
Bundoora, VIC 3086
Country 93411 0
Australia
Phone 93411 0
+61 0413399008
Fax 93411 0
Email 93411 0
[email protected]
Contact person for scientific queries
Name 93412 0
Prof Richard Gray
Address 93412 0
La Trobe University
Plenty Rd & Kingsbury Dr,
George Singer Building, Level 3,
Bundoora, VIC 3086
Country 93412 0
Australia
Phone 93412 0
+61394796743
Fax 93412 0
Email 93412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual-level data - demographics and all clinical outcomes - will be made available. We will also make a data dictionary available.
When will data be available (start and end dates)?
Immediately following the award of Ph.D. no end date
Available to whom?
Anyone who wishes can access the data set
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via figshare https://latrobe.figshare.com/


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
EmbaseAdherence therapy for adults with type 2 diabetes: a feasibility study of a randomized controlled trial.2023https://dx.doi.org/10.1186/s40814-023-01294-2
N.B. These documents automatically identified may not have been verified by the study sponsor.