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Table 1 Mapping activities to MRC framework

From: Using the Medical Research Council framework for development and evaluation of complex interventions in a low resource setting to develop a theory-based treatment support intervention delivered via SMS text message to improve blood pressure control

1 Developing complex intervention
 1.1 Identifying evidence base by reviewing published literature and existing systematic reviews i Epidemiology of high blood pressure and its control
ii Evidence base on treatment adherence
iii Identified existing systematic reviews and trials of interventions delivered by mobile phone
 1.2 Identifying and developing appropriate theory i Literature review and meeting with stakeholders and experts to decide on theory, behaviour change techniques, and intervention strategies
ii Qualitative studies with stakeholder groups to refine content and test delivery system
 1.3 Modelling process and outcomes i Used causal modelling approach to link determinants of behaviour to behaviours and subsequent health outcomes
2 Assessing feasibility and piloting methods
 2.1 Testing procedures for acceptability, compliance, and intervention delivery i. Tested components for feasibility and acceptability
ii. Service tested full intervention over 8-week period
 2.2 Estimating recruitment and retention i. Recruitment from general outpatient department of a large, single primary care facility
ii. Review of literature to determine best practice for ongoing retention of trial participants
 2.3 Determining sample size i. Data from observational studies used to calculate sample size
3 Evaluating complex intervention
 3.1 Assessing effectiveness i. Set up a large pilot RCT (South African National Clinical Trials Register DOH-27-1212-386; 28/12/2012; Pan Africa Trial Register PACTR201411000724141; 14/12/2013); ClinicalTrials.gov NCT02019823; 24/12/2013). Primary outcome change in mean systolic blood pressure at 1 year, data on secondary outcomes along hypothesised casual pathway also collected. Usual care group get infrequent non-health related SMS text messages, intervention groups get regular SMS text messages designed to support treatment adherence
 3.2 Understanding change processes i. Intervention fidelity assessed using message delivery logs and logs of participant contact
ii. In final phase of the trial qualitative study of participants, health care workers, and service providers to explore how the intervention might work (necessary pre-requisites), could be optimised, contextual factors, specific key ingredients which could be included in future interventions
 3.3 Cost-effectiveness i. Data on costs of developing, testing, and delivering intervention as well as health service costs collected and analyses in process
4 Implementation and beyond
 4.1 Dissemination i. Peer review publications, conference presentations, public engagement activities, making available tools used to develop and deliver intervention
 4.2 Surveillance, monitoring, and long-term outcomes i. Consent to access routinely collected health data. If intervention shown to be effective then process and outcome data could inform additional pragmatic trials.