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Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System (BewegtVersorgt)

7 novembre 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

552

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Allemagne
      • Erlangen, Allemagne, 91058
        • Recrutement
        • Friedrich-Alexander-University Erlangen-Nürnberg
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention Group
Participants receive a physical activity referral scheme.
Comportemental: Physical activity referral scheme (PARS)
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.
Comparateur actif: Control Group
Participants receive physical activity advice from general practitioners.
Comportemental: Physical activity advice (PAA)
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in physical activity-related health competence: BGK Questionnaire
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in quality of life: EuroQol (EQ-5D-5L)
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
Délai: Baseline (T0), 24 weeks (T1; only intervention group)
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.
Baseline (T0), 24 weeks (T1; only intervention group)
Changes in stages of change: transtheoretical model (TTM)
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
Délai: Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
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.
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews
Délai: Through study completion, an average of 1 year
The (semi-) structured interview is based on RE-AIM and asks specifically about adoption, implementation, and maintenance.
Through study completion, an average of 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Erlangen-Nürnberg

Les enquêteurs

  • Chercheur principal: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-University Erlangen-Nürnberg

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2022

Achèvement primaire (Anticipé)

1 décembre 2023

Achèvement de l'étude (Anticipé)

1 décembre 2023

Dates d'inscription aux études

Première soumission

9 juin 2021

Première soumission répondant aux critères de contrôle qualité

23 juin 2021

Première publication (Réel)

1 juillet 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 novembre 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 novembre 2022

Dernière vérification

1 novembre 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BewegtVersorgt

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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