None listed
Conditions
Brief summary
The primary objectives of the study are 1) to determine self-reported adherence or non-adherence to prescribed cardiac medications in cardiac patient referred to a cardiac rehabilitation program and 2) to explore individual, behavioural and environmental factors that affect adherence to cardiac medications. The secondary objective is to conduct pilot-testing of the hypothesis that, compared to standard care alone, standard care plus a multifaceted intervention comprising motivational interviewing techniques and text message reminders will enhance cardiac medication adherence among cardiac patients referred to attend cardiac rehabilitation program. The study hypothesis is that motivational interviewing (MINT) counselling and text message reminders delivered in an outpatient setting in addition to standard care will enhance maintenance of medication adherence in cardiac patients compared to standard care alone.
Interventions
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 n
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.
Sponsors
Ali Hussein Alek Al-Ganmi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed