Pandey 2017.
Study characteristics | ||
Methods |
Aim of study: to assess the impact of text message reminders on adherence to medications and exercise in patients recently discharged from the hospital after a myocardial infarction (MI) Study design: RCT (pilot single centre; individual allocation) Number of arms/groups: 2 |
|
Participants |
Description: patient/consumer Geographic location: Canada Setting: hospital discharge to community Inclusion criteria: ≥ 18, discharged from hospital after MI in preceding 2 weeks and enrolled in a structured cardiac rehabilitation programme. Patients receiving treatment with medications from all 4 of the following classes: antiplatelets, BB, ACEI/A2RA, and statins Exclusion criteria: patients taking medications in dosing regimens > once daily, no mobile phone, unable to read and write in English or provide informed consent, those incarcerated Number of participants randomised: 34 Number of participants included in analysis: 33 (17 and 16) Age: 64.6 ± 11.5 vs 62.1 ± 11.0; subgroup > 65: 7 (41%) vs 8 (50%) Gender: 11 (65%) vs 2 (12%); not reported for subgroup Ethnicity: not specified Number of medications: cardiac (post‐MI) prescription medication: 10.1 ± 4.5 vs 8.0 ± 5.2; not reported for older subgroup Frailty/Functional impairment: not specified Cognitive impairment: dementia: 3 (18%) vs 2 (13%) Comorbidities: no total comorbidity score |
|
Interventions |
Group 1 ‐ Text message reminder: once‐daily text message at the time patient preferred to take medications. Text messages simply indicated that patient should remember to take medications and contained no identifiable information such as medication names or classes (e.g. "Please remember to take your morning medications now") Group 2 ‐ Usual care (no text message) Co‐intervention: all participants received outpatient cardiac rehab programme for 3 months and follow‐up assessment at 12 months Provider: automated (set up by cardiac rehab nurses, then automated to send daily) Where: via text message When and how often: daily for 12 months Intervention personalised: not really ‐ standard wording: "Please remember to take your morning medications now"; time of day was modified for patient |
|
Outcomes |
Timing of outcome assessment: 12 months Medication adherence (subjective) : self‐reported adherence: participants asked to use a logbook to record name and timing of medications taken on a daily basis. Logbooks were collected monthly. Absolute medication adherence was calculated as percentage of total prescribed doses that were actually taken each month. 12‐month adherence calculated as the mean of each of the 12 monthly measurements. Adherence outcome is % of days covered |
|
Notes | Trial registration: NCT02783287 Consumer involvement: not specified Funding source: unclear; Brigham and Women's Hospital and University of Waterloo listed under sponsors and collaborators Dropout: 1 control withdrew |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by a web‐based random number generator in a 1:1 ratio |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients and their healthcare providers were aware of the arm to which they had been randomised |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label trial; no mention of blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Only 1 withdrew ‐ but may be relevant given low patient numbers, especially in older people subgroup |
Selective reporting (reporting bias) | Low risk | As described in methods |
Other bias | Unclear risk | Persistence with the 4 post‐MI medications not reported. Typically this is well below 100%, plus some medications may be stopped due to ADRs, etc. It is unlikely that no medications were stopped for any patients over 12 months. It is unclear how this was accounted for in the study |