Park 2013.
Study characteristics | ||
Methods | Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design: (2‐sided confidence interval) Open‐label |
|
Participants | N recruited = 90 N randomised = 90 (30 control, 30 intervention‐1, 30 intervention‐2) N reported outcomes = 84 Mean age 59.2 years (SD 9.4, range 35 – 83), 24% women INCLUSION CRITERIA “Inclusion criteria were: (a) >/=21 years of age, (b) hospitalized for non‐ST elevation MI, ST elevation MI, or PCI, (c) prescribed an antiplatelet medication [thienopyridine class of ADP receptor inhibitors and/or a cyclooxygenase inhibitor (i.e., aspirin)], (d) prescribed a statin medication (HMG‐CoA reductase inhibitors), (e) owned a mobile phone with text messaging capability, and (f) were able to speak, read, and understand English.” EXCLUSION CRITERIA “Exclusion criteria included: (a) cognitive impairment that limited ability to understand and complete questionnaires, and (b) inability to operate a mobile phone.” COUNTRY/SETTING: USA STUDY PERIOD: "Recruitment took place between April 2012 and March 2013 until the final sample size was obtained." |
|
Interventions | Number of study centres: 1 Text Message Reminders + Text Message Education (1) “Patients who received text messages (TM) for medication reminders and health education.” TM Education Alone (2) “Patients who received TM for health education.” No TM (3) “Patients who did not receive TM.” |
|
Outcomes | “First, data from the Medication Event Monitoring System (MEMS) provided four different indicators of adherence including: (1) total number of doses taken, (2) percentage of prescribed doses taken, (3) percentage of days correct number of doses were taken, and (4) percentage of doses taken on schedule. Second, the response rate to the TM medication reminders by the TM Reminders + TM Education group was to correspond to adherence. Third, medication adherence was assessed using the MMAS‐8, a self‐report measure completed at baseline and at follow‐up. The MMAS‐8 is a well‐validated tool and correlates with other adherence measures such as medication refill rates and electronic monitoring devices (e.g., MEMS).” "For the secondary aim, feasibility and patient satisfaction were assessed by successful execution of the intervention, patient participation, and by the Mobile Phone Use Questionnaire. The latter questionnaire was developed for the purpose of the study and sought to obtain patients’ experience with using mobile phones for medication reminders and/or education.” PRIMARY OUTCOME: medication adherence SECONDARY OUTCOME: feasibility and patient satisfaction |
|
Notes |
Publication details Commercial funding/non‐commercial funding/other funding: “Funding for research materials was provided by a grant from the Graduate Division of University of California, San Francisco and a scholarship from the UCSF/Hartford Center of Geriatric Nursing Excellence. CareSpeak Communications provided the use of the mobile Health manager platform, which is designed to improve medical therapy adherence using two‐way text messaging.” Stated aim for study “The primary aim was to compare medication adherence among three groups: (1) patients who received text messages (TM) for medication reminders and health education (TM Reminders + TM Education), (2) patients who received TM for health education (TM Education Alone), and (3) patients who did not receive TM (No TM). The secondary aim was to explore feasibility and patient satisfaction with mobile phone use to improve medication adherence among patients who received TM.” |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Group assignment was generated by random allocation sequence using blocks of six that was prepared by a biostatistician. The PI assigned patients to their groups by distributing envelopes in consecutive, numbered order." |
Allocation concealment (selection bias) | Low risk | "Eligible patients opened sealed opaque envelopes that contained the assignment to one of three groups (TM Reminders + TM Education, TM Education Alone, or No TM)" |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded "open‐label study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Ninety patients were recruited to participate and completed baseline questionnaires; however, six patients withdrew or were lost to follow‐up" |
Selective reporting (reporting bias) | Low risk | All outcomes reported |