Back to resultsEstablishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System (BewegtVersorgt)
Primary Purpose
Non-Communicable Chronic Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Physical activity referral scheme (PARS)
Physical activity advice (PAA)
Sponsored by
About this trial
This is an interventional treatment trial for Non-Communicable Chronic Diseases focused on measuring physical activity promotion, physical activity referral scheme, physician-initiated, behaviour change
Eligibility Criteria
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
Sites / Locations
- Friedrich-Alexander-University Erlangen-NürnbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Participants receive a physical activity referral scheme.
Participants receive physical activity advice from general practitioners.
Outcomes
Primary Outcome Measures
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
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.
Changes in physical activity-related health competence: BGK Questionnaire
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.
Secondary Outcome Measures
Changes in quality of life: EuroQol (EQ-5D-5L)
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.
Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
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.
Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
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.
Changes in stages of change: transtheoretical model (TTM)
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.
Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
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.
Full Information
NCT ID
NCT04947787
First Posted
June 9, 2021
Last Updated
November 7, 2022
Sponsor
University of Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT04947787
Brief Title
Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
Acronym
BewegtVersorgt
Official Title
Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Communicable Chronic Diseases
Keywords
physical activity promotion, physical activity referral scheme, physician-initiated, behaviour change
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
552 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants receive a physical activity referral scheme.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants receive physical activity advice from general practitioners.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity referral scheme (PARS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity advice (PAA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in self-reported moderate to vigorous physical activity (min/week): BSA 3.0 questionnaire
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Title
Changes in physical activity-related health competence: BGK Questionnaire
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Secondary Outcome Measure Information:
Title
Changes in quality of life: EuroQol (EQ-5D-5L)
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Title
Changes in self-efficacy towards physical activity: Selbstwirksamkeit zur sportlichen Aktivität-Skala (SSA-Scale)
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Title
Changes in participants' perceived autonomy support: Health Care Climate Questionnaire-Deutschland (HCCQ-D)
Description
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.
Time Frame
Baseline (T0), 24 weeks (T1; only intervention group)
Title
Changes in stages of change: transtheoretical model (TTM)
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Title
Changes in sport- and movement-related self-concordance: Sport- und bewegungsbezogenen Selbstkonkordanz Skala (SSK-Scale)
Description
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.
Time Frame
Baseline (T0), 12 weeks (T1), and 24 weeks (T2)
Other Pre-specified Outcome Measures:
Title
Experience of participating actors (general practitioners, exercise professionals): (semi-) structured interviews
Description
The (semi-) structured interview is based on RE-AIM and asks specifically about adoption, implementation, and maintenance.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anja Weissenfels, Dr.
Phone
+4991318528182
Email
anja.weissenfels@fau.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Klamroth, Dr.
Phone
+4991318528182
Email
sarah.klamroth@fau.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Organizational Affiliation
Friedrich-Alexander-University Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Alexander-University Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91058
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Pfeifer, Prof. Dr.
Phone
+49 9131 8525465
Email
klaus.pfeifer@fau.de
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35964042
Citation
Weissenfels A, Klamroth S, Carl J, Naber I, Mino E, Geidl W, Gelius P, Abu-Omar K, Pfeifer K. Effectiveness and implementation success of a co-produced physical activity referral scheme in Germany: study protocol of a pragmatic cluster randomised trial. BMC Public Health. 2022 Aug 13;22(1):1545. doi: 10.1186/s12889-022-13833-2.
Results Reference
derived
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Establishing a Physical Activity Referral Scheme for People With Noncommunicable Diseases in the German Healthcare System
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