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Trial registered on ANZCTR


Registration number
ACTRN12616000910404
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
8/07/2016
Date last updated
8/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Motivational Interviewing (MINT) and Text Message Reminders on Medication Adherence among Patients with Heart Disease.
Scientific title
Behaviour Change Interventions to Improve Medication Adherence in Patients with Cardiac Disease
Secondary ID [1] 289547 0
Nil known
Universal Trial Number (UTN)
U1111-1184-7192
Trial acronym
BCI-MA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication Adherence 299269 0
Medication Non-adherence 299271 0
Cardiac Disease 299272 0
Heart Disease 299273 0
Condition category
Condition code
Cardiovascular 299275 299275 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design of this study is sequential mixed methods with a nested pilot Randomised Controlled Trial (RCT); three interrelated phases, as:
Phase one: A survey design will be used to identify cardiac patients’ medication adherence/non-adherence patterns and the factors that are most strongly associated with their medication non-adherence. The purpose of the survey is to gather quantitative data about medication adherence, patient behaviours, beliefs and other factors associated with medication non-adherence as well as patients’ demographic data. Paper based questionnaires will be used. The questionnaires will be self-administered, simple and easy to complete, and suitable for participants with low literacy.
Phase two: Semi-structured interviews will be used to gather descriptive qualitative data to explore the phenomenon of cardiac patients’ adherence to medications and how they respond to factors that affect medication adherence. Semi-structured interviews will be used to explore views of patients about their cardiac medications, and factors that influence their medication adherence. Semi-structured interviews were chosen because this is a flexible method of collecting self-report data and allows the researcher to prepare questions ahead of time. This will provide in-depth understanding, supplement and explain quantitative results from Phase one.
Information generated from phases one and two will be used to identify participants eligible to take part in the pilot trial phase, and synthesised to inform motivational interviewing processes aiming at addressing individual patients’ medication adherence-related needs and support patients’ adherence to their cardiac medications;
Pilot trial phase: Patients identified as non-adherent based on the result of exploratory phases (phase one and two) will be invited to participate in the pilot randomised controlled trial phase. This pilot RCT will test the effectiveness of a multifaceted intervention, comprising motivational interviewing (MINT) plus text message reminders, to influence the adherence of patients to their cardiac medications. The RCT will compare the effect of a multifaceted intervention with current standard care to enhance medication adherence outcomes. The control group will receive the standard usual care cardiac rehabilitation program and they will complete the baseline and follow-up questionnaires.

Intervention Arm:
Patients identified as non-adherent based on the result of exploratory phases (phase one and two) will be invited to participate in the pilot randomised controlled trial (RCT) phase. This pilot RCT will test the effectiveness of a multifaceted intervention, comprising motivational interviewing (MINT) plus text message reminders (TM), to influence the adherence of patients to their cardiac medications. The RCT will compare the effect of a multifaceted intervention with current standard care to enhance medication adherence outcomes.
Participants in the intervention group who referred to cardiac rehabilitation program at Prince of Wales Hospital (POWH) will receive usual care plus behavioural counselling about medication adherence using motivational interviewing (MINT) techniques and text message reminders (TM). Each patient will receive approximately 30-40 minutes of a single MINT counselling session by the researcher following recruitment. The core of motivational interviewing is for the counsellor to be simultaneously sympathetic and supportive, as well as directive in moving patients toward change by strengthening their own reasons for change. As part of the MINT counselling, the researcher has the opportunity to provide information that the patient may need or to explore some of the barriers that keep this patient from adherence to cardiac medications. The MINT counselling will be delivered by the researcher who is a registered nurse with 14 years experience and received training on how to implement MINT session. Text message reminders (TM) will be sent to these participants: one text message daily for two weeks, then on alternate days for two weeks and then on a weekly basis for the next 6 months. The content of the text message reminders will vary according to the patients’ non-adherence factors. An example of the text message reminder is:
‘Hello Mr/Mrs…………. Have you refilled your heart medication today? Please text back “Y” if your answer is “Yes, I have refilled my medication before receiving this text”, “R” if your answer is “the message has reminded me, I will refill my medication” and “N” if your answer is “No”. Thank you. Ali and the research Team’.

The researchers will use a structured MINT counselling script designed for patients with low adherence to medications, with each session tailored to the medication adherence characteristics of the individual patient. All MINT sessions will be audio taped and reviewed by a clinician qualified in MINT to ensure fidelity to the technique.

Control Arm:
Patients randomised to the control group will receive standard care alone for the study period. They will be contacted at baseline and 6 months to complete the same measurements and interviews as the intervention group.
Intervention code [1] 295147 0
Behaviour
Comparator / control treatment
The control group will receive the standard usual care cardiac rehabilitation program and they will complete the baseline and follow-up medication adherence questionnaires.

Control group
Active

Outcomes
Primary outcome [1] 298757 0
Self-reported medication adherence/non-adherence rate. This outcome will be assessed by the Medication Adherence Questionnaire (MAQ).
Timepoint [1] 298757 0
Timepoint: at baseline.
Primary outcome [2] 298873 0
Medication Adherence Factors. These will be measured by: 1) Adherence to Refills and Medications Scale, 2) Belief about Medicine Questionnaire, 3) Medication Adherence Self-Efficacy Scale-Revised, and 4) Medication Specific Social Support.
Timepoint [2] 298873 0
Timepoint: at baseline.
Secondary outcome [1] 325135 0
Self-reported medication adherence/non-adherence rate. This outcome will be assessed by the Medication Adherence Questionnaire (MAQ).
Timepoint [1] 325135 0
Timepoint: at 6 months post-intervention commencement.
Secondary outcome [2] 325510 0
Medication Adherence Factors. These will be measured by: 1) Adherence to Refills and Medications Scale, 2) Belief about Medicine Questionnaire, 3) Medication Adherence Self-Efficacy Scale-Revised, and 4) Medication Specific Social Support.
Timepoint [2] 325510 0
Timepoint: at 6 months post-intervention commencement.

Eligibility
Key inclusion criteria
1) 18 years of age or older;
2) Established diagnosis of cardiac disease by their physician and referred to the cardiac rehabilitation program at POWH;
3) Prescribed at least one cardio-protective medication at least 7 days prior to recruitment;
4) They must have primary responsibility for taking their medications themselves (i.e. whilst a carer may play a role in supporting or prompting medication taking, they should not be identified as being accountable for ensuring the patient’s adherence to their medication schedule);
5) Participants must be able to speak, read and understand English, own a personal mobile phone, and be able to receive and reply to phone calls and text messages;
6) They must be willing to give written or oral informed consent to participate to in the study.
7) To be eligible for the trial phase, patients must be identified with at least one medication non-adherence factor, indicated by results of the medication adherence questionnaire and responses to the interview questions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are deaf, blind or unable to accept phone calls will be excluded. Those clinically judged with cognitive impairment that limits their ability to understand and answer study questions will be excluded.

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)
Participants will be randomised after they have consented to participate in the trial phase, so that the decision to participate has no bearing on which arm of the trial they are allocated to. Allocation is not concealed.
Neither participants nor researcher can be blinded to the group allocation of participants (intervention or usual care only groups).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence will be generated by computerised random number generator and using permutated blocks in order to assure equal numbers in each arm, balanced at set intervals at 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for the RCT was calculated based on data from Ma et al. (2014). The researcher predefined and utilised the value for the means (M) and standard deviation (SD) based on Ma et al. (2014). The resultant value for 2 sided test for alpha = 0.05, with power = 0.80, is a sample size of 9 for each group. Allowing for 50% loss to follow-up, based on these calculations, a sample size of 28 participants for both groups will be needed in the pilot trial phase to ensure an adequate response rate for statistical analysis.

The researcher will compare the two groups at baseline. Data will be analysed according to intention to treat analysis using statistical methods based on the study hypothesis. Descriptive statistical analyses will be used to illustrate the participants’ baseline characteristics. The independent samples t-test will be used to compare the mean medication adherence questionnaire scores (MSSS, MAQ, ARMS, BaMQ, and MASER-R) between the intervention and usual care groups. Paired samples t-test analysis will be used to test within groups differences on medication adherence questionnaire scores (MSSS, MAQ, ARMS, BaMQ, and MASER-R). Logistic regression analysis will be applied to identify variables that significantly influence adherence to medications (i.e. self-efficacy, beliefs, level of confidence, and social support).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
Date of last participant enrolment
Anticipated
2/01/2017
Actual
Date of last data collection
Anticipated
3/07/2017
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6033 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 13482 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293938 0
University
Name [1] 293938 0
University of Technology Sydney (UTS)
Country [1] 293938 0
Australia
Primary sponsor type
Individual
Name
Ali Hussein Alek Al-Ganmi
Address
Faculty of Health, University of Technology Sydney (UTS)
Building 10, Level 7, 235-253 Jones Street, Ultimo Sydney, NSW 2007.
Country
Australia
Secondary sponsor category [1] 292763 0
University
Name [1] 292763 0
University of Technology Sydney (UTS)
Address [1] 292763 0
Faculty of Health, University of Technology Sydney (UTS)
Building 10, Level 7, 235-253 Jones Street, Ultimo Sydney, NSW 2007.
Country [1] 292763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295353 0
Human Research Ethics Committee (South Eastern Sydney Local Health District)
Ethics committee address [1] 295353 0
Ethics committee country [1] 295353 0
Australia
Date submitted for ethics approval [1] 295353 0
14/03/2016
Approval date [1] 295353 0
08/06/2016
Ethics approval number [1] 295353 0
16/085
Ethics committee name [2] 295390 0
Research Support Office (South Eastern Sydney Local Health District)
Ethics committee address [2] 295390 0
Ethics committee country [2] 295390 0
Australia
Date submitted for ethics approval [2] 295390 0
14/03/2016
Approval date [2] 295390 0
29/06/2016
Ethics approval number [2] 295390 0
16/G/103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 942 942 0 0
/AnzctrAttachments/370973-2016.06.08 Ethics Approval 16-085.pdf
Attachments [2] 943 943 0 0
/AnzctrAttachments/370973-Trial Protocol.pdf
Attachments [3] 945 945 0 0
/AnzctrAttachments/370973-Ali HREC n SSA approval.pdf

Contacts
Principal investigator
Name 66950 0
Mr Ali Al-Ganmi
Address 66950 0
Faculty of Health, University of Technology Sydney (UTS), Building 10, Level 7, 235-253 Jones Street, Ultimo Sydney, NSW 2007.
Country 66950 0
Australia
Phone 66950 0
+61 408692046
Fax 66950 0
Email 66950 0
ali.h.al-ganmi@student.uts.edu.au
Contact person for public queries
Name 66951 0
Leila Gholizadeh
Address 66951 0
Faculty of Health, University of Technology Sydney (UTS), Building 10, Level 7, 235-253 Jones Street, Ultimo Sydney, NSW 2007.
Country 66951 0
Australia
Phone 66951 0
+61 2 9514 4814
Fax 66951 0
Email 66951 0
Leila.Gholizadeh@uts.edu.au
Contact person for scientific queries
Name 66952 0
Lin Perry
Address 66952 0
Prince of Wales Hospital, Sydney and Sydney Eye Hospitals, G75, East Wing Edmund Blacket Building, Prince of Wales Hospital, Barker St, Randwick NSW 2031.
Country 66952 0
Australia
Phone 66952 0
+61 2 9382 4709
Fax 66952 0
Email 66952 0
Lin.Perry@uts.edu.au

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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