A RCT to explore the effectiveness of supporting adherence to nebuliser medication in adults with cystic fibrosis: fidelity assessment of study interventions.

BACKGROUND: A multi-component self-management intervention 'CFHealthHub' was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes. METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform. RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant. CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care. TRIAL REGISTRATION: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).

A machine-learning assisted review of the use of habit formation in medication adherence interventions for long-term conditions.

Adherence to medication in long-term conditions is around 50%. The key components of successful interventions to improve medication adherence remain unclear, particularly when examined over prolonged follow-up periods. Behaviour change theories are increasingly interested in the utility of habit formation for the maintenance of health behaviour change, but there is no documentation on how habit has been conceptualised in the medication adherence intervention literature, or what effect the key technique identified in habit formation theory (context dependent repetition) has in these studies. To examine this, a machine-learning assisted review was conducted. Searches of MEDLINE, EMBASE and PSYCInfo and the reference list of a comprehensive systematic review of medication adherence interventions yielded 5973 articles. Machine learning-assisted title and abstract screening identified 15 independent RCTs published between 1976 and 2021, including 18 intervention comparisons of interest. Key findings indicate that conceptualisations of habit in the medication adherence literature are varied and behaviour change technique coding identified only six studies which explicitly described using habit formation. Future work should aim to develop this evidence base, drawing on contemporary habit theory and with explicit demonstration of what techniques have been used to promote habit formation.

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

BACKGROUND: Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden. METHODS: Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes. RESULTS: Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs. CONCLUSIONS: The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

An Analysis of Behaviour Change Techniques Used in a Sample of Gestational Weight Management Trials.

INTRODUCTION: Maternal obesity and excessive gestational weight gain are associated with multiple adverse outcomes. There is a lack of clarity on the specific components of effective interventions to support pregnant women with gestational weight management. METHOD: All 44 studies within a preexisting review of lifestyle interventions, with a potential to impact on maternal weight outcomes, were considered for content analysis. Interventions were classified using Behaviour Change Technique (BCT) taxonomy clusters to explore which categories of BCT were used in interventions and their effectiveness in managing gestational weight gain. RESULTS: The most commonly used BCTs were within the categories of "feedback and monitoring," "shaping knowledge," "goals and planning," "repetition and substitution," "antecedents," and "comparison of behaviours." For diet and mixed interventions "feedback and monitoring," "shaping knowledge," and "goals and planning" appeared the most successful BCT categories. CONCLUSIONS: Poor reporting within studies in defining the BCTs used, in clarifying the differences in processes between intervention and control groups, and in differentiating between the intervention and research processes made BCT classification difficult. Future studies should elaborate more clearly on the behaviour change techniques used and report them accurately to allow a better understanding of the effective ingredients for lifestyle interventions during pregnancy.

Women's and Midwives' Perspectives on the Design of a Text Messaging Support for Maternal Obesity Services: An Exploratory Study.

This study was aimed to explore women's and midwives' views on the use of mobile technology in supporting obese pregnant women with healthy lifestyle choices. A purposive sample of 14 women and midwives participated in four focus groups in Doncaster, UK. A content analysis of the transcripts from the first focus group led to the emergence of three main constructs with associated subcategories including Benefits ("modernising," "motivating," "reminding," and "reducing" the sense of isolation), Risks and Limitations (possibility of "being offensive," "creating pressure or guilt," and "being influenced by mood"), and Service Delivery (making it "available to all pregnant women," giving attention to the "message tone" and development of "message content"). They also suggested the use of other modalities such as web-based services for weight management during pregnancy. Based on the above results a text messaging service was developed and presented to the 2nd focus group participants who confirmed the positive views from the first focus group on the use of the text messaging as being supportive and informative. The participants also welcomed "women's engagement and choice" in deciding the content, timing and frequency of messages. The results informed the development of a text messaging service to support maternal obesity management. The implementation and acceptability of this service requires further investigation.

The assessment of menstrual synchrony: comment on Weller and Weller (1997)

A. Weller and L. Weller (1997) claimed to report "the definitive study of menstrual synchrony" (p. 148). To allow for cycle variability, they used the following criterion for synchrony: It occurred in 2 out of 3 months. The underlying assumption of the state of menstrual synchrony is that cycle length variability is minimal. The present article uses a random selection of cycle lengths from a distribution described by R. F. Vollman (1977) to illustrate how variable cycle lengths cause a fluctuation from synchrony to a synchrony. A. Weller and L. Weller's (1997) study is not, therefore, conclusive, and future studies of menstrual synchrony should include an assessment of cycle variability as well as onset difference.