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      Implementation and evaluation of an individualized physical exercise promotion program in people with manifested risk factors for multimorbidity ( MultiPill-Exercise): a study protocol for a pragmatic randomized controlled trial

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          Abstract

          Background

          Multimorbidity is a major problem in Europe, increasing the need for prevention and rehabilitation programs. In Germany no guidelines have been developed that focus on patients with multiple chronic non-communicable diseases (NCDs). Benefits of physical activity (PA) and exercise in NCDs have been proven, but most interventions focus on single conditions. The evaluation of the effectiveness, efficiency and safety of PA programs in patients suffering from multiple NCDs and the feasibility of the implementation within the health care service remain open research questions.

          Methods

          The multi-site randomized controlled pragmatic trial includes 320 sedentary subjects with at least two of the following NCDs, either manifested or in a pre-stage with evident risk factors: Cardio-vascular disease, Diabetes mellitus type 2, knee/ hip osteoarthritis and obesity. Participants will be recruited from general practitioners and medical specialists and randomized to standard care of a statutory health insurance or MultiPill-Exercise. Standard care includes a choice of one or a maximum of two 8- to 12-week health programs, including nutrition, exercise, relaxation or special disease management programs. MultiPill-Exercise is based on the bio-psycho-social health model, considering a person-oriented perspective in light of given individual characteristics and context factors. The 24-weeks intervention focuses on aerobic and strengthening exercises in line with the WHO PA recommendations. Psychological and pedagogical elements along with behavior change techniques are implemented to ease the initiation and maintenance of exercise participation and lifestyle change, including nutrition. Primary outcome will be short- and long-term PA measured with the European Health Interview Survey-Physical Activity Questionnaire (EHIS-PAQ). Secondly, the effectiveness of the program on generic, disease specific, economic, and exercise behavioral parameters, as well as program adherence and safety will be evaluated.

          Discussion

          Results of this trial evaluate the PA intervention program in people with multiple NCDs in a real-life scenario. It will serve as a proof of concept with the opportunity of translation into routine practice. This approach, as a multi-site RCT with its rigorous methods and standardized operating procedures for the conduction of the intervention, will allow valid conclusions for the implementation of PA interventions in people with multimorbidity.

          Trial registration

          The trial was registered at www.drks.de (ID: DRKS00025033) on 30th September 2021.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s12889-022-13400-9.

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          SPIRIT 2013 statement: defining standard protocol items for clinical trials.

          The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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            Process evaluation of complex interventions: Medical Research Council guidance

            Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
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              Psychometric assessment of three newly developed implementation outcome measures

              Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist’s perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change. Results All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α’s from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions. Conclusions The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned. Electronic supplementary material The online version of this article (doi:10.1186/s13012-017-0635-3) contains supplementary material, which is available to authorized users.
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                Author and article information

                Contributors
                simone.schweda@med.uni-tuebingen.de
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central (London )
                1471-2458
                13 June 2022
                13 June 2022
                2022
                : 22
                : 1174
                Affiliations
                [1 ]GRID grid.411544.1, ISNI 0000 0001 0196 8249, Department of Sports Medicine, Faculty of Medicine, , University Hospital, Medical Clinic, ; Hoppe-Seyler Str. 6, 72076 Tuebingen, Germany
                [2 ]Interfaculty Research Institute for Sports and Physical Activity, Tuebingen, Germany
                [3 ]GRID grid.491710.a, ISNI 0000 0001 0339 5982, Allgemeine Ortskrankenkasse AOK Baden-Wuerttemberg, ; Presselstrasse 19, 70191 Stuttgart, Germany
                [4 ]GRID grid.10392.39, ISNI 0000 0001 2190 1447, Department of Sports Science Tuebingen, Faculty of Economic and Social Science, , Eberhard Karls University Tuebingen, ; Wilhelmstrasse 124, 72074 Tuebingen, Germany
                [5 ]GRID grid.411544.1, ISNI 0000 0001 0196 8249, Department for Clinical Epidemiology and Applied Biostatistics, Faculty of Medicine, , University Hospital, Medical Clinic, ; Silcherstrasse 5, 72076 Tuebingen, Germany
                Author information
                http://orcid.org/0000-0001-5827-2664
                Article
                13400
                10.1186/s12889-022-13400-9
                9190168
                35698074
                71faed5b-5f68-4620-a242-d0116d41bd3b
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 10 December 2021
                : 11 May 2022
                Funding
                Funded by: Allgemeine Ortskrankenkasse (AOK) Baden-Württemberg
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2022

                Public health
                multimorbidity,physical exercise,diabetes mellitus type 2,hypertension,osteoarthritis,overweight,obesity,health services research,cost-analysis,behavior change techniques,randomized controlled trial

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