Data extraction of intervention design and effect, and author’s programme theory from all four included empirical studies on mHealth in Kenya, South Africa, Honduras and Mexico and Pakistan
| Author, year and country | Research design, participant sample, setting, main outcome measure and secondary outcome | Intervention description, intervention components and study duration | Intervention effect on primary, secondary and process outcomes and overview | Authors’ programme theory for the intervention (if stated) or probable programme theory, based on description of intervention (including likely mechanism/intervention function) | Did the intervention work as intended or not? |
| Lester et al, 201044: Kenya | Design: RCT Sample: Patients infected with HIV, over 18 years old, initiating ART for the first-time. n=803 total. Setting: One urban university clinic, one urban non-governmental organisation clinic and one rural public health service clinic. Main outcome measure: Self-reported ART adherence (>95% of prescribed doses in the past 30 days); plasma HIV-1 viral RNA load suppression (<400 copies per mL). Secondary outcome: Rate of attrition (not having a final visit at 12 months) and rates of several categories of attrition (mortality, withdrawal from the study, transfer to non-study clinics and loss to follow-up without identifiable cause). | Nurse or clinical officer sends the patients a text message: ‘How are you?’ each Monday morning. Patients asked to respond within 48 hours with: ‘Doing well’ or ‘Have a problem’. Nurse/clinical officer phones the patient who has problems or if there is no response. Patients received intervention training when recruited. Text message sent using multiple recipient bulk messaging. Intervention components:
| Impact outcome: Self-reported adherence: intervention group: 168 (62%); control group: 132 (50%) RR 0.81; 95% CI (0.69 to 0.94); p=0·006 Viral suppression: -intervention group 156 (57%); control group 128 (48%); RR 0.85; 95% CI (0.72 to 0.99); p=0.04. Secondary outcome: No significant associations with the intervention. Intervention group: 19% missing, 9% mortality, 3% withdrawal, 6% loss to follow-up and 1% transferred out. Control group: 23% missing, 11% mortality, 1% withdrawal, 10% loss to follow-up and 0% transfer out (to a different clinic not in the study). Process outcomes: At the end of the study, 191 of 194 patients in the intervention group reported they would like the text message programme to continue, of whom 188 (98%) said they would recommend it to a friend. In the focus group sessions, many patients in the intervention group also reported that they thought the text message support service was valuable. Outcome overview: Significant change in self-reported adherence to ART and suppression of viral loads between groups. Male/urban residence favoured adherence compared with the control group. | The text message acted as an indirect reminder to the patients to take ART and provided support (perceived support was valuable). The patients know they will be followed up if they do not respond, so the design of the intervention acts as an incentive to respond otherwise the nurse or clinical officer will contact them. By receiving a weekly message that asks how they are, the patient is made to feel cared for during the first period they are taking HIV treatment. |
Yes—the feeling of being supported via digital communication was important. The text message intervention was well received by patients, many of whom reported that they felt ‘like someone cares’. Patients had to reply to the nurse or clinical officer within 48 hours. of receiving the text message, otherwise the nurse will check on them, gave them an incentive to keep on track of replying, which was a quick and straightforward process from their phones. The action of being told they had to respond within a given time initiated the behaviour of the communication between the patient and health worker. No—there is no actual evidence that the weekly reminder caused the continued or improved adherence in people to take their treatment. Sharing a phone and being a woman reduced the intervention effect, but these factors are unexplained. |
| Bobrow et al, 201645: South Africa | Design: RCT Sample: Patients with hypertension (SBP<220 mm Hg and a DBP<120 mm Hg) over 21 years. n=1188 total. Setting: One urban large public health service clinic. Main outcome measure: Change in systolic blood pressure at 12 months from baseline measured with a validated oscillometric device. Secondary outcome: Health status measured using EuroQul Group 5-Dimension Self-Report Questionnaire (EQ-5D), proportion of scheduled clinic appointments attended, retention in clinical care, satisfaction with clinic services and care, hospital admissions, self-reported adherence to medication (did they collect their medication) and understanding of basic hypertension knowledge. |
Information-only message intervention: Automated system sends the patient the text message with predefined messages with health worker’s name at the end of message. Interactivity—weekly, at a time predefined by the participant. Participants received one message per week, either a reminder to attend an upcoming appointment (48 hours prior to scheduled appointment) or a message selected-at-random from the message library. Interactive message intervention: Information-only intervention PLUS participants could also select messages allocated to the interactive adherence support and could also respond to selected messages using free-to-user ‘Please-Call-Me’ requests. These requests generated an automated series of responses from the text message delivery system (not a health worker nor a phone call response) offering trial participants options to cancel or change an appointment or change the timing and language of the text messages. Patients also received a text message were sent to either thank participants for attending their appointment or alert participants about a missed appointment 48 hours. postdate. There is no personal contact between nurse and participant. Intervention components:
| Impact outcome: The mean (95% CI, p value) adjusted difference in change for the information-only message group compared with usual care was systolic blood pressure −2.2 mm Hg (−4.4 to −0.04, p=0.046) and for the interactive message group compared with usual care −1.6 mm Hg (−3.7 to 0.6, p=0.16). Secondary outcomes: Out of the 86% of patients, the trial had adherence data available, 63% from the information only message intervention group, 60% for the interactive message intervention group and 49% from the usual care group, had 80% of proportion of days covered for blood pressure lowering medication for a 12-month period. EQ-5D scores, attendance at clinic appointments, retention in clinical care, treatment and clinic satisfaction, hypertension knowledge, self-reported adherence, hospital admissions and differences in medication changes did not differ between groups. Subgroup analysis: There was no statistically significant heterogeneity in the treatment effects and there was an indication that active interventions were more effective among older patients (55 years), patients in better control at baseline (<140 mm Hg) and among those with a shorter duration of hypertension (<10 years). | By receiving a behavioural intervention delivered via text message as support, this could improve collection of medicines and may have a small impact on blood pressure as compared with usual care in a general outpatient population of adults with high blood pressure. Getting information to people at a time that is relevant to them and prompts to take medication should help to encourage the patient because they have chosen when to receive the message and this time is most appropriate to their daily routine. Reminder messages with information about forthcoming or missed clinic appointments remind the patient about where they need to be and when. Reminders about who they can contact if they are worried or concerned about any side effects of the medication gives the patient increased knowledge and channels of support. By receiving a ‘Happy Birthday’ message this makes the patient feel cared for by the health service, on their day of birth. Study design issues: The intervention includes behaviour change cluster techniques such as repetition and substitution, goals and planning and social support which are based on Michie’s Behaviour Change Wheel. |
No—the primary outcome did not improve. Blood pressure levels in both intervention groups did not decrease during the trial period suggesting the text message (information and interactive) did not help to reduce blood pressure control in adults with diagnosed high BP and on treatment (partly because many of them were stable at baseline). Yes—the secondary outcomes did improve. Proportion of days of medication covered (adherence to medication) was higher in both intervention groups suggesting that they were remembering to collect their medication because of the reminders: the two intervention groups were collecting the medication more regularly over the control groups. |
| Piette et al, 201243: Honduras and Mexico | Design: RCT Sample: Patients with hypertension (‡140 mm Hg if non-diabetic) or hypertension and diabetes* (‡130 mm Hg if diabetic) 18–80 years of age. Intervention group (text message) and preplanned subgroup analysis: patients with low literacy or high BP management information needs (n=89). Control group (standard care) (n=92). *Blood glucose was not being measured in this study. Setting: Four private and two public clinics in Honduras and two clinics in Mexico. Main outcome measure: Change in systolic blood pressure (SBPs ‡160 mm Hg and<180 mm Hg). Secondary outcomes: Patients’ perceived general health status, depressive symptoms (using a validated Spanish 10-item Centre for Epidemiological Studies-Depression Scale), medication-related problems (adherence measured using the Morisky Scale) and satisfaction with care related to hypertension. | Automated telephone monitoring and behaviour-change calls plus home BP monitoring among hypertensive patients. The calls were aimed at gathering information about the patient’s BP, BP self-monitoring, medication adherence and diet and to provide tailored advice based on the patient’s responses. Patients’ with hypertension received a home blood pressure monitor and were given training. The intervention focused mainly on providing information and self-management education to patients via interactive voice calls or automated calls—to check their BP and were asked about recent systolic values above and below the normal range, medication adherence and intake of salty foods. Based on what they said, the patients were then offered additional self-care information during the call and prompts to seek medical attention or medication refills to address unacceptably high or low BP. Structured email alerts for health workers were generated automatically when patients reported that at least half the time in the prior week they had an SBP ‡140 mm Hg (patients with non-diabetes), ‡ 130 mm Hg (diabetic patients) or 100 mm Hg (all patients) or if the patient reported rarely or never taking his or her BP medication or less than a 2 week supply. Patients had the option of enrolling with a family member or friend, who received a brief automated telephone update regarding the patient’s self-reported health status each week, including information about the patient’s hypertension self-care and how that caregiver could help the patient self-manage more effectively. Intervention components:
| Impact outcome: Intervention patients’ SBPs decreased 4.2 mm Hg relative to controls (95% CI 9.1 to 0.7; p=0.09). In the subgroup with high information needs, intervention patients’ average SBPs decreased 8.8 mm Hg (–14.2 to –3.4, p=0.002). 57% of intervention patients had controlled BP at follow-up compared with 38% of the comparison group (p=0.006). Process outcome: More than 88% of patients reported that the automated calling system was easy to learn and use, and 93% reported that the automated calls included useful information for managing their hypertension. Overall, 94% of intervention patients reported being very satisfied with the intervention and 76% reported that the programme was excellent. Secondary outcomes: At follow-up, patients had lower depressive scores and fewer medication-related problems for example, worry about the effects of their medication. Overall health was reported and there was greater satisfaction with care-related to hypertension. Subgroup analysis: Patients with low literacy or high BP management information needs: those with problems learning about their health problems because of difficulty understanding written information, had never been told they had hypertension or had not spoken with a clinician about their BP in more than 6 months or were confused about their medication regimen. They had an average of 8.8 mm Hg reduction in SBP relative to controls (95% CI 14.2 to –3.4; p=0.002). Outcome overview: In the overall sample, there was a non-statistically significant (p=0.09) 4.2 mm Hg relative decrease in SBP among intervention patients. In the subgroup of patients with low literacy or high information needs, 8.8 mm Hg reduction in average SBP was observed with a significantly greater proportion of intervention than control patients having BPs in the acceptable range. Intervention patients at follow-up had SBPs that were 4.2 mm Hg lower on average than control patients (95% CI 9.1 to 0.7; p=0.09). | By receiving automated self-management calls, plus home blood pressure monitoring kit, this can improve outcomes for hypertensive patients as reminders to check blood pressure readings several times per week this acts a nudge to action. The mechanisms of action included: (1) During the calls patients were reminded to check their BP regularly and were asked about recent systolic values above and below the normal range, medication adherence, and intake of salty foods. This regular checking-in meant the patient had to keep on top of their management and regularly verbally discuss their chronic disease. (2) The health workers were alerted via email if a patient’s blood pressure changed or if medication was not taken. Therefore, the patients knew that their results were going to be reported if they failed to take their BP medication. This created an incentive to adhere. (3) The support of a family member or friend meant that the patient’s self-reported health status and self-care were given to the treatment supporter. This process meant the patient was accountable to someone else. Another person was part of their chronic disease management. The information-based intervention had greater impact on patients who reported a greater need for hypertension-related knowledge and education because they had low literacy or high information needs and valued additional supportive information. |
Yes—blood pressure decreased. Calls are effective over a short follow-up period. Yes—particularly for the subgroups with low literacy and high BP. The intervention focused on providing information and self-management education to patients. |
| Kamal et al, 201542: Pakistan | Design: RCT Sample: Patients with stroke 18 years and over. >1 month since last episode of stroke. Use of at least two drugs such as (but not limited to) antiplatelets, statins and antihypertensives to control risk factors of stroke (n=83). Control group (n=79). Setting: One urban hospital’s neurology and stroke unit. Main outcome measure: Change in self-reported stroke medication adherence after 2 months of receiving the text message (using the Morisky Scale). Secondary outcome: Blood pressure was measured using the Mindray Datascope Equator to detect change in systolic and DBP. | Automated text message reminders customised to each patient’s individual prescription. Patients were required to respond to the text message, stating if they had taken their medicines by replying ‘Yes’ or ‘No’. Also, customised twice-weekly health information text messages were sent according to medical and drug profile of every patient. The timing of the message was decided according to the prescription so that health messages did not collide with reminder messages. Intervention components:
| Impact outcome: Mean difference in adherence score between the intervention group and the control group (usual care) was 0.54 (95 % CI 0.22 to 0.85; p≤0.01). Process outcome: Patient satisfaction and acceptability using text messages to improve clinical outcome, was 96% after the 2-month period. Secondary outcome: Reduction in DBP. No major effect was observed on systolic blood pressure due to reasonably limited exposure time to the intervention. Overview outcome: A significant affect was found in the intervention group’s adherence to stroke medication. It was found that being retired and/or unemployed, being educated and with a higher dosing frequency, were positively related to the level of medication adherence found. | By customising the messages, the patients are likely to be more satisfied to act as they were asked to reply with a very simple response. Text messages were customised for each patient depending on their medication prescription (compared with just receiving simple knowledge transfer messages). The patients were being treated therefore as single cases. Also, the timing of the messages sent out according to the patient’s dosing schedule was important in increasing adherence. This timing targeted an action because they were received at a time appropriate to the person. These messages targeted both intentional non-adherence and non-intentional non-adherence by providing knowledge and belief change messages and other cuing, nudging and reminder behaviours to take medications. Reminders about behaviour were likely to entice the patient to take their medication along with giving praise and encouragement. Study design issues: Content and language of intervention messages are designed on The Health Belief Model and Social Cognitive Theory. | Yes—in the 2 months studied, adherence improved. There was also a slight reduction in DBP. |
ART, antiretroviral therapy; BP, blood pressure; DBP, diastolic blood pressure; RCT, randomised controlled trial; RR, Relative Risk; SBP, systolic blood pressure.