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

Kirsten Bobrow, Andrew Farmer, Nomazizi Cishe, Ntobeko Nwagi, Mosedi Namane, Thomas P Brennan, David Springer, Lionel Tarassenko, Naomi Levitt, Kirsten Bobrow, Andrew Farmer, Nomazizi Cishe, Ntobeko Nwagi, Mosedi Namane, Thomas P Brennan, David Springer, Lionel Tarassenko, Naomi Levitt

Abstract

Background: Several frameworks now exist to guide intervention development but there remains only limited evidence of their application to health interventions based around use of mobile phones or devices, particularly in a low-resource setting. We aimed to describe our experience of using the Medical Research Council (MRC) Framework on complex interventions to develop and evaluate an adherence support intervention for high blood pressure delivered by SMS text message. We further aimed to describe the developed intervention in line with reporting guidelines for a structured and systematic description.

Methods: We used a non-sequential and flexible approach guided by the 2008 MRC Framework for the development and evaluation of complex interventions.

Results: We reviewed published literature and established a multi-disciplinary expert group to guide the development process. We selected health psychology theory and behaviour change techniques that have been shown to be important in adherence and persistence with chronic medications. Semi-structured interviews and focus groups with various stakeholders identified ways in which treatment adherence could be supported and also identified key features of well-regarded messages: polite tone, credible information, contextualised, and endorsed by identifiable member of primary care facility staff. Direct and indirect user testing enabled us to refine the intervention including refining use of language and testing of interactive components.

Conclusions: Our experience shows that using a formal intervention development process is feasible in a low-resource multi-lingual setting. The process enabled us to pre-test assumptions about the intervention and the evaluation process, allowing the improvement of both. Describing how a multi-component intervention was developed including standardised descriptions of content aimed to support behaviour change will enable comparison with other similar interventions and support development of new interventions. Even in low-resource settings, funders and policy-makers should provide researchers with time and resources for intervention development work and encourage evaluation of the entire design and testing process.

Trial registration: The trial of the intervention is registered with South African National Clinical Trials Register number (SANCTR DOH-27-1212-386; 28/12/2012); Pan Africa Trial Register (PACTR201411000724141; 14/12/2013); ClinicalTrials.gov ( NCT02019823 ; 24/12/2013).

Keywords: Adherence; Behaviour modification; Health care; Intervention development; MRC framework; Self-management.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Human Research Ethics Committee of the University of Cape Town (HREC UCT 418/211, 017/2014), the Oxford Tropical Research Ethics Committee (OXTREC 03–12, 13–14), and the Metro District Health Services, Western Cape (RP 141/2011). Trial conduct was overseen by a trial steering committee. All participants provided written informed consent. All the requirements of the Helsinki Declaration of 2008 were fulfilled.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Process of intervention development adapted from Smith et al. [20]
Fig. 2
Fig. 2
Hypothesised causal pathways and measures for evaluation for SMS text Adherence suppoRt (StAR) trial

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