Kamal 2015.
Methods |
Design: two‐arm, parallel RCT Setting: Karachi, Pakistan Recruitment period: not stated Length of intervention: 2 months |
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Participants |
Inclusion criteria: age greater than 18 years old; history of stroke(s) confirmed by neuroimaging at the time of the episode; more than 1 month since last episode of stroke; use of at least two drugs such as (but not limited to) antiplatelets, statins, anti‐hypertensives to control risk factors of stroke; modified Rankin Score of 3 or less (so that they are able to operate mobile phones); possession of a personal cell phone that the patient has access to at all times. In the case of patients who do not own or are unable to use mobile phones, they must have a caregiver available at all times who possesses a cell phone; ability to receive, comprehend and reply to an SMS in English, Nastaleeq Urdu (local Urdu script) or Roman Urdu. In the case of patients who themselves are unable to receive, comprehend or reply to an SMS, they must have caregivers available at all times who could perform the above mentioned tasks Exclusion criteria: biological impairment in reading or responding to SMS in the caregiver such as (but not limited to) loss of vision, visual field cuts, aphasia in case the patient himself/herself is supposed to receive SMS; Diagnosed organ dysfunction or malignancy such as hepatic, renal or malignancy; plans to travel outside the country inside the two months following enrolment Randomised: n = 200. Intervention = 100, control = 100 Number available for follow‐up: n = 162. Intervention arm: 17 lost to follow‐up: 10 unwilling to come, 2 sick, 3 out of station 2 discontinued intervention. Control arm: 21 lost to follow‐up: 17 unwilling to come, 4 out of station Mean age in years (SD): Control: 57.6 (1.3), intervention: 56 (1.5) Sex (% male): 67.5 % male (64% in control 71% in intervention) Disease duration: at least one month |
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Interventions |
Intervention: In addition to the usual care, intervention group received automated SMS reminders customised to their individual prescription. The participants were required to respond to the SMS stating if they have taken their medicines. Moreover, twice weekly health information SMS were also sent to the intervention group. Health information SMS were customised according to medical and drug profile of every patient by the research team. Control: patients received the usual standard of care provided at the centre for stroke patients. This primarily consisted of regular follow‐up visits (as advised by their neurologist) with their stroke neurologist. In general, these were at 1, 3, 5,9,12 months after a stroke. Each patient was provided with a telephone number that could be used to reach the stroke team in case of an emergency and each patient was also reminded of their clinic appointments 1–2 days prior via SMS and/or phone Text type: automated‐ two‐way "The messages were designed in a weekly schedule at preset days of the week for total 8 weeks e.g., Wednesday and Saturday week 1 for patient X. The timings were decided according to the prescription so that health messages do not collide with the reminder messages for that day. Usually 5 pm was found feasible for most participants. These messages did not ask for a reply. These health information SMS were codified by Michie’s Taxonomy of Behavioural Change for repeatability" |
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Outcomes |
Primary outcome: Change in medication adherence after 2 months using the Morisky Medication Adherence Scale (MMAS) Secondary Outcome: Change in blood pressure, acceptability of SMS Medication adherence: at baseline: Control 6.6 (0.17) Intervention 6.6 (0.16) at two months: Control 6.7 (1.32) Intervention 7.4 (0.93) Adjusted mean difference (adjusted for baseline, number of pills, dosing frequency, age, gender, employment status, education, use of alarms) 0.54 (95% CI 0.22, 0.85) Blood pressure The mean diastolic blood pressure in the intervention group was 2.6 mmHg (95 % CI; −5.5 to 0.15) lower compared to the usual care group Serious adverse events: Not discussed |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Central randomised computer‐generated sequence. The staff who randomised and those who assessed and those who delivered the intervention were separate. |
Allocation concealment (selection bias) | Low risk | Concealed in white envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not discussed but based on intervention high risk |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Only mention is that "The staff who randomized and those who assessed and those who delivered the intervention were separate". |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20% lost to follow‐up |
Selective reporting (reporting bias) | Low risk | All primary outcomes reported on. Blood pressure not mentioned in protocol, but acceptability and patient satisfaction were. |
Other bias | Unclear risk | Nothing discussed |