Study protocol for the Screen-Free Time with Friends Feasibility Trial.

BACKGROUND: Children are spending less leisure time with their friends in person and an increasing amount of time with digital screens. These changes may negatively affect children's physical and mental health. The Screen-Free Time with Friends Feasibility Trial will test the feasibility, including acceptability and compliance, of an intervention designed to reduce screen media usage and encourage physical interaction with friends during leisure time in 9-11-year-old children. METHODS: A non-randomized single-group feasibility trial will be conducted from March to October 2023 including approximately 75 children (aged 9-11 years) and 75 parents (at least 1 per child) from 3 different schools recruited from 3 different municipalities in Denmark. The Screen-Free Time with Friends intervention is a multicomponent intervention targeting families, afterschool clubs, and local communities. It has been developed using a systematic process guided by the Medical Research Council UK's framework for developing and evaluating complex interventions. With a systems perspective in mind, the intervention and implementation approach has been designed to facilitate adaptation to the specific needs of diverse local communities while maintaining the core components of the intervention. Feasibility and acceptability of the intervention will be assessed during the intervention using process evaluation inspired by the RE-AIM framework including questionnaires and interviews with the municipality project managers, research team members, local ambassadors and stakeholders, parents and school, and afterschool club personnel. In addition, participation, recruitment, retention rate, and compliance to the outcome measurements will be investigated and presented. DISCUSSION: The trial will investigate the feasibility and acceptability of the Screen-Free Time with Friends intervention, the recruitment strategy, and the planned outcome measurements. This feasibility study will investigate necessary refinements before the implementation of the intervention program in a larger cluster randomized controlled trial to evaluate its impact. CLINICALTRIALS: gov, ID: NCT05480085. Registered 29 July 2022. https://clinicaltrials.gov/ct2/show/NCT05480085?cond=Screen+free+time+with+friends&draw=2&rank=1.

Co-creating active communities: processes and outcomes of linking public rehabilitation programs with civic engagement for active living in a Danish municipality.

BACKGROUND: Increased levels of physical activity are associated with beneficial health effects for people with type 2 diabetes, cardiovascular disease and/or severe obesity; however, transforming knowledge about these effects into action is challenging. The aim of this paper is to explore lessons learnt from a co-creation process in a partnership project involving local stakeholders, including citizens, and researchers. The purpose of the process was to link a public health care institution with civil society organisations in the local community to make it possible for citizens to continue to be physically active after ending their public rehabilitation. Secondarily, this paper aims to develop a conceptual model of the above process. METHODS: The study constitutes the first part of Project Active Communities and was based on a partnership between three research institutions and a Danish rural municipality, involving municipal and civil society stakeholders and citizens with type 2 diabetes, cardiovascular disease and/or severe obesity in co-creation of concrete interventions for implementation. The co-creation process was divided into two tracks, one involving citizens (two workshops) and one involving municipal and civil society stakeholders (two workshops). The two tracks were concluded with a final workshop involving all stakeholders, including local politicians. Data sources are focus groups and bilateral meetings, workshop observations, and questionnaires. RESULTS: Lessons learnt include the importance of having a flexible timeframe for the co-creation process; giving room for disagreements and matching of mutual expectations between stakeholders; the value of a coordinator in the municipality to achieve acceptance of the project; and the significance of engaging local politicians in the co-creation process to accommodate internal political agendas. We have developed a conceptual model for a co-creation process, where we outline and explain three distinct phases: stakeholder identification and description, co-creation, and prototyping. The model can be adapted and applied to other sectors and settings. CONCLUSIONS: This study documents lessons learnt in a co-creation process aiming to link a public health care institution with civil society organisations in the local community. Further, this study has specified productive co-creative processes and documented the various phases in a conceptual model.

It is well known that physical activity has health benefits for people with chronic diseases. In this study, our aim was to explore lessons learnt from a co-creation process and develop a model for others to apply. The study was based on a partnership between three research institutions and a Danish rural municipality, involving municipal and civil society stakeholders and citizens with type 2 diabetes, cardiovascular disease and/or severe obesity. During the study, the above-mentioned stakeholders were invited to five workshops, where interventions for linking a public health care institution and civil society organisations were co-created. The five co-creation workshops led to the identification of four interventions, linking public health care institutions and civil society organisations. Lessons learnt from this project, which can be used by others who wish to design and conduct a co-creative process with diverse stakeholders, include: the importance of having a flexible timeframe for the co-creation process, as delays can easily occur in the unpredictable process of co-creation giving room for disagreements and matching of mutual expectations between stakeholders, as a common understanding of each stakeholder's motives is important for the success of the project the importance and value of a coordinator in the municipality to achieve acceptance of the project the significance of engaging local politicians in the co-creation process to take internal political agendas into consideration. We conclude by identifying three phases­a stakeholder, a co-creation, and a prototyping phase­in a model for co-creation that may be adapted and used by others.

[Clinical implementation of complex interventions].

Intervention research is rapidly evolving and the updated Medical Research Council's framework from 2021 recommends a number of elements to consider when developing, adapting and evaluating complex interventions. We aimed to introduce the framework into the Danish language, and it is now ready for use in the efforts to developing and evaluating interventions that can help closing the evidence-practice gap. Using the framework systematically is expected to optimise evidence-based decisions of implementing new or settle obsolete interventions targeted patients, providers or healthcare organisations. This review gives a brief summary of the updated recommendations.

Heart Rehabilitation for All (HeRTA): Protocol for a feasibility study and pilot randomized trial.

INTRODUCTION: Today, 50% of people with cardiac disease do not participate in rehabilitation. The HeRTA-study aims to develop and test a sustainable rehabilitation model supporting vulnerable patients in participating in rehabilitation and long-term physical activity. METHODS: A feasibility study with a non-blinded pilot randomized trial was developed in collaboration with partners and cardiac patients to test a multi-component rehabilitation intervention across hospital, municipality, and civil society. The study runs from January 2020 to December 2024. Eligibility criteria for participants: a) diagnosed with either ischemic heart disease, persistent atrial fibrillation, heart failure, or have had cardiac valve surgery, b) residents in Hvidovre Hospitals uptake area, c) cognitively functional, d) physically able to participate in rehabilitation. Patient recruitment will be located at Hvidovre Hospital, Capital Region of Denmark, data collection at Hvidovre Hospital, Rehabilitation Center Albertslund, the Danish Heart Association, and in two municipalities (Hvidovre and Brøndby). Patients in the control group have access to usual care at the hospital: rehabilitation-needs-assessment, patient education, and physical training. After or instead of hospital rehabilitation, the patient can be referred to municipal rehabilitation with patient education, and a total of 12 weeks of physical training across sectors. Patients in the intervention group will in addition to usual care, have access to an information book about cardiac disease, patient supporters from the Danish Heart Association, Information materials to inform employers about the employees' rehabilitation participation, a rehabilitation goal setting plan, a support café for relatives, and follow-up phone calls from physiotherapists 1 and 3 months after rehabilitation to support physical activities. Patients with vulnerabilities will additionally receive patient education conducted in small groups, pro-active counselling by a cardiac nurse, psychologist, or social worker, paid transportation to rehabilitation, and paid membership in a sports association. Patients are computer block-randomized so patients with vulnerability are distributed evenly in the two study arms by stratifying on a) a cut-off score of ≥ 5 in the Tilburg Frailty Indicator questionnaire and/or b) need of language translator support. A power calculation, based on an estimated 20% difference in participation proportion between groups, 80% power, a type 1 error of 5% (two-tailed), results in 91 participants in each study arm. The primary outcome: rehabilitation participation (attending ≥ two activities: patient education, smoking cessation, dietary counseling, and physical training) and reaching at least 50% attendance. Secondary outcomes: health-related quality of life, coping strategies, level of physical activities, and sustainability regarding participation in active communities after rehabilitation. The study is registered at ClinicalTrials.gov (NCT05104658). RESULTS: Differences between changes in outcomes between groups will be analyzed according to the intention-to-treat principle. Sensitivity analysis and analysis of the effect of the combined activities will be made. A process evaluation will clarify the implementation of the model, the partnership, and patients' experiences. CONCLUSION: Cross-sectoral collaborations between hospitals, municipalities, and organizations in civil society may lead to sustainable and affordable long-term physical activities for persons with chronic illness. The results can lead to improve cross-sectoral collaborations in other locations and patient groups.

Advancing 'real-world' trials that take account of social context and human volition.

BACKGROUND: The recent paper in Trials by Porter and colleagues highlights the utility of applying a critical realism approach in randomised trials, an approach central to the Medical Research Council's (MRC) Framework for the Development and Evaluation of Complex Healthcare Interventions. The MRC framework offers a pragmatic step towards a more open systems approach that bridges randomised evaluation with social context and human agency in an effort to improve the generalisability of trial outcomes. MAIN BODY: The MRC framework has contributed to the proliferation of a more open systems approach in health research; however, the broader acceptance of the realist approach to health research does not seem to be emulated by norms in research fund allocation, which largely prioritises laboratory-based research. CONCLUSION: This commentary is simply a plea, to those who make the strategic decisions regarding allocation of research funding, to support all phases of health intervention research in complex systems that contribute to the development of effective, translational and sustainable interventions in the promotion of health.

[Insufficient evidence on the effectiveness of brief alcohol interventions in health care].

Very brief alcohol interventions (approx. 5 min.) are recommended for implementation in Danish municipalities by the The Danish Health and Medicines Authority. We have investigated the evidence supporting this recommendation. A lack of clarity remains about the active components in brief interventions and the extent to which the existing evidence base can be interpreted as efficacy or effectiveness studies. This has important implications for the generalizability of the trials. There is insufficient evidence on the effectiveness of very brief alcohol interventions and implementation is premature.

Internet-based brief personalized feedback intervention in a non-treatment-seeking population of adult heavy drinkers: a randomized controlled trial.

BACKGROUND: Internet-based interventions for heavy drinkers show promising results, but existing research is characterized by few studies in nonstudent adult populations and few comparisons with appropriate control groups. OBJECTIVE: To test whether a fully automated Internet-based brief personalized feedback intervention and a fully automated Internet-based personalized brief advice intervention in a non-treatment-seeking population of heavy drinkers would result in a reduced alcohol intake. METHODS: We conducted a 3-arm parallel randomized controlled trial in a general population-based sample of heavy drinkers. The 54,157 participants (median age of 58 years) were screened for heavy drinking. Of the 3418 participants who had a weekly alcohol consumption above 14 drinks for women and 21 drinks for men, 1380 (619 women) consented to take part in the trial and were randomly assigned to an Internet-based brief personalized feedback intervention group (normative feedback, n = 476), an Internet-based personalized brief advice intervention group (n = 450), or a nonintervention control group (n = 454). Follow-up after 6 and 12 months included 871 and 1064 participants, respectively, of all groups combined. The outcome measure was self-reported weekly alcohol consumption. We analyzed the data according to the intention-to-treat principle. To examine changes over time and to account for the multiple time measurements, we used a multilevel linear mixed model. To take attrition into account, we used multiple imputation to address missing data. RESULTS: The intervention effect of the Internet-based brief personalized feedback intervention, determined as the mean additional difference in changes in alcohol consumption in the Internet-based brief personalized feedback intervention compared with the control group, was -1.8 drinks/week after 6 months and -1.4 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -4.0 to 0.3 at 6 months, -3.4 to 0.6 at 12 months). The intervention effect of the Internet-based personalized brief advice intervention was -0.5 drinks/week after 6 months and -1.2 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -2.7 to 1.6 at 6 months, -3.3 to 0.9 at 12 months). CONCLUSIONS: In this randomized controlled trial we found no evidence that an Internet-based brief personalized feedback intervention was effective in reducing drinking in an adult population of heavy drinkers. TRIAL REGISTRATION: ClinicalTrials.gov NCT00751985; http://clinicaltrials.gov/ct2/show/NCT00751985 (Archived by WebCite at http://www.webcitation.org/68WCRLyaP).