Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System (BewegtVersorgt)
7 de novembro de 2022 atualizado por: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
The BewegtVersorgt project involved co-producing a physical activity referral scheme (PARS) for inactive persons with underlying non-communicable diseases. Various relevant actors of the German healthcare system (e.g., representatives of physicians, health insurance providers, sports organizations, exercise representatives of exercise professions, representatives of patients) participated in the co-production process.
The purpose of this study is to evaluate the effectiveness of co-produced PARS in the Erlangen-Nuremberg-Fürth region. Local general practitioners and exercise professionals will carry out the implementation of the PARS in standard care. The cluster-randomized study includes two intervention arms; one group will receive specific support from physical activity experts to increase physical activity (PARS). The control group will receive only the physician's advice and then continue to engage in physical activity on their own (PAA). The participants will be followed up at 12 and 24 weeks.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
552
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Anja Weissenfels, Dr.
- Número de telefone: +4991318528182
- E-mail: anja.weissenfels@fau.de
Estude backup de contato
- Nome: Sarah Klamroth, Dr.
- Número de telefone: +4991318528182
- E-mail: sarah.klamroth@fau.de
Locais de estudo
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Erlangen, Alemanha, 91058
- Recrutamento
- Friedrich-Alexander-University Erlangen-Nürnberg
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Contato:
- Klaus Pfeifer, Prof. Dr.
- Número de telefone: +49 9131 8525465
- E-mail: klaus.pfeifer@fau.de
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- 18 years and older; living in the region of Erlangen-Nürnberg-Fürth, Germany;
- At least one of the following existing non-communicable diseases (controlled type 2 diabetes mellitus; cardiovascular diseases; obesity (BMI ≥ 30 kg/m2); arthrosis in knee and/or hip);
- Not meeting German PA recommendations (less than 150 minutes/week of moderate-intensity aerobic activity or less than 75 minutes/week of vigorous-intensity aerobic activity or any other equivalent combination);
- The person can safely participate in physical activities based on general practitioners' clinical judgment.
Exclusion Criteria:
- The person plans to leave the region of Erlangen-Nürnberg-Fürth during the study period;
- The person participating in another study with similar content;
- The person is or plans to be absent for more than four weeks during the 12-week-intervention period;
- Person has cognitive impairments that prevent an effective communication with the general practitioner and the therapist;
- Persons with mental illness such as psychotic, substance abuse, mood, personality disorders;
- Unstable clinical situation or serious health impairments that prevent from undertaking physical activity safely (e.g., acute myocardial infarction, unstable angina pectoris, fever, terminal tumor diseases
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention Group
Participants receive a physical activity referral scheme.
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Participants of the intervention group will receive brief physician advice and be referred to an exercise professional (e.g., physiotherapist, sports therapist) for a more intensive counseling intervention.
The counseling intervention consists of an initial assessment, individual physical activity counseling (360'), a final assessment after 12 weeks, and a follow-up assessment after 24 weeks.
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Comparador Ativo: Control Group
Participants receive physical activity advice from general practitioners.
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Participants of the control group will only receive brief physician advice regarding the promotion of physical activity and as an information sheet with tips on how to adopt a more physically active lifestyle.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen; BSA-F) is a German questionnaire that assesses the amount of physical activity during the last four weeks.
It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score).
Participants are required to report the frequency and duration of activities executed during the last four weeks.
Minutes of leisure-time physical activity per week and sport-/exercise-related activity per week are calculated to get the physical activity and the sports score.
Both scores can be combined to receive the overall volume of physical activity completed during leisure-time/transportation and sport-/exercise-related activities.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Changes in physical activity-related health competence: BGK Questionnaire
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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This will be measured by the German version of the Physical Activity-Related Health Competence questionnaire.
The questionnaire consists of 44 total items that measure three sub-competencies necessary for a health-promoting physical activity behavior: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8),
physical activity-related self-regulation competence (14 items; min = 0, max = 14.8).
Higher scores indicate higher competencies.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Changes in quality of life: EuroQol (EQ-5D-5L)
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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The EQ-5D-5L is a self-administered quality of life scale that consists of a descriptive system and a visual analog scale.
The descriptive system contains five well-being dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression.
Each dimension has five levels of severity (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems), each coded with numbers from one to five.
The result obtained is a 5-digit code that represents the health state profile of the participant.
The visual analog scale assesses the overall current health.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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This will be measured by a German instrument (Selbstwirksamkeit zur sportlichen Aktivität; SSA-Scale), including 12 items that assess the confidence someone has to perform a planned physical activity in the face of various conditions that may act as barriers.
Each item is scored on a seven-point Likert scale representing the level of confidence from '1' meaning not sure at all and '7' meaning the participant is very confident of performing the physical activity as planned even in the face of a particular challenge.
The total scores range from 12 to 84, where the higher the score, the greater the self-efficacy.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
Prazo: Baseline (T0), 24 weeks (T1; only intervention group)
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We will use the German version of the Health Care Climate Questionnaire (HCCQ-D) to measure the participant's perception of autonomy support from the general practitioner.
It incorporates 15 statements with seven-point response options that indicate the level of agreement ranging from strongly disagree to strongly agree.
Higher scores indicate higher perceived autonomy support.
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Baseline (T0), 24 weeks (T1; only intervention group)
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Changes in stages of change: transtheoretical model (TTM)
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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We will use one German question that is based on the transtheoretical model of behavior change.
The five response options represent five stages of change: pre-contemplation, contemplation, preparation, action, and maintenance.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
Prazo: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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This will be evaluated with the self-administered German scale (Sport- und bewegungsbezogenen Selbstkonkordanz-Skala; SSK-Scale) that measures the self-concordance.
The SSK-Scale contains 12 items grouped into four subscales: intrinsic, identified, introjected, and extrinsic motivation.
The subscales' scores for introjected and extrinsic motivation will be subtracted from the sum of the identified and intrinsic motivation subscales to receive the overall score.
Thus, the overall score ranges from minus ten (-10) to ten, where a higher score suggests a higher level of sports- and movement-related self-concordance.
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Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews
Prazo: Through study completion, an average of 1 year
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The (semi-) structured interview is based on RE-AIM and asks specifically about adoption, implementation, and maintenance.
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Through study completion, an average of 1 year
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-University Erlangen-Nürnberg
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2022
Conclusão Primária (Antecipado)
1 de dezembro de 2023
Conclusão do estudo (Antecipado)
1 de dezembro de 2023
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de junho de 2021
Primeira postagem (Real)
1 de julho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de novembro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de novembro de 2022
Última verificação
1 de novembro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BewegtVersorgt
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
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