Patients with complex multimorbidity face a high treatment burden and frequently have low quality of life. General practice is the key organisational setting in terms of offering people with complex multimorbidity integrated, longitudinal, patient-centred care. This protocol describes a pragmatic cluster randomised controlled trial to evaluate the effectiveness of an adaptive, multifaceted intervention in general practice for patients with complex multimorbidity.

In this study, 250 recruited general practices will be randomly assigned 1:1 to either the intervention or control group. The eligible population are adult patients with two or more chronic conditions, at least one contact with secondary care within the last year, taking at least five repeat prescription drugs, living independently, who experience significant problems with their life and health due to their multimorbidity. During 2023 and 2024, intervention practices are financially incentivised to provide an extended consultation based on a patient-centred framework to eligible patients. Control practices continue care as usual. The primary outcome is need-based quality of life. Outcomes will be evaluated using linear and logistic regression models, with clustering considered. The analysis will be performed as intention to treat. In addition, a process evaluation will be carried out and reported elsewhere.

The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its most recent form and good clinical practice recommendations, as well as the regulation for informed consent. The study was submitted to the Danish Capital Region Ethical Committee (ref: H-22041229). As defined by Section 2 of the Danish Act on Research Ethics in Research Projects, this project does not constitute a health research project but is considered a quality improvement project that does not require formal ethical approval. All results from the study (whether positive, negative or inconclusive) will be published in peer-reviewed journals.

NCT05676541.

Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal deaths globally and require close monitoring of blood pressure (BP) to mitigate potential adverse effects. Despite the recognised need for research on self-monitoring of blood pressure (SMBP) among pregnant populations, there are very few studies focused on low and middle income contexts, which carry the greatest burden of HDPs. The study aims to understand the perceptions, barriers, and operational considerations for using a smartphone software application to perform SMBP by pregnant women in Lombok, Indonesia.

This study includes a combination of focus group discussions, in-depth interviews and workshop observations. Pregnant women will also be provided with a research version of the smartphone BP application to use in their home and subsequently provide feedback on their experiences. The study will include pregnant women with current or past HDP, their partners and the healthcare workers involved in the provision of antenatal care services within the catchment area of six primary healthcare centres. Data obtained from the interviews and observations will undergo thematic analyses using a combination of both inductive and deductive approaches.

The study was approved by the World Health Organization (WHO) and Human Reproduction Programme (HRP) Research Project Review Panel and WHO Ethical Review Committee (A65932) as well as the Health Research Ethics Committee, Faculty of Medicine, Universitas Mataram in Indonesia (004/UN18/F7/ETIK/2023).

Findings will be disseminated through research publications and communicated to the Lombok district health offices. The analyses from this study will also inform the design of a subsequent impact evaluation.