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Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD (COPD-AReNa)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Pulmonary Rehabilitation (usual care)

Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program

After care: Exercise and physical activity promotion

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, exercise, physical activity promotion, behavior change, internet-based intervention, physical literacy, rehabilitation aftercare, mhealth, telerehabilitation, feasibility

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications A-D and stages 1-4.
Internet access at home
owning a smartphone with the operating system Android or iOS
basic computer and internet skills (e. g. using web browser)
ability to operate a smartphone (especially to install mobile applications)
ability to read, write and comprehend as well as communicate electronically

Exclusion Criteria:

severe concomitant disease, which will affect the ability to be physically active more than COPD for example, cancer or severe cardiac, neurological, orthopaedic or metabolic comorbidities)
cognitive impairment that hampers study implementation
Lack of ability to speak German

Sites / Locations

Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern SüdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Usual care rehabilitation and aftercare

Rehabilitation and aftercare (aligned)

Arm Description

Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program.

Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program. During rehabilitation, participants already get familiarized with components of the after care program.

Outcomes

Primary Outcome Measures

Acceptability of the intervention and participants' satisfaction (participant perspective)

Semi-structured interviews will be conducted with persons with COPD that participated in the study.

Acceptability and practicability of intervention (therapist perspective)

Semi-structured interviews will be conducted with therapists that delivered the intervention.

Recruitment

Number of participants screened, number of eligible participants, number of participants recruited, reasons for exclusion during recruitment

Compliance with intervention protocol

Completed training sessions, e-learning modules and telephone calls with the therapist will be documented for each participant.

Retention

Percentage of included participants that complete T2 assessment.

Secondary Outcome Measures

Dyspnea, cough, sputum, pain

Questionnaire: Numeric Rating Scales (self-developed) The questionnaire consists of seven items. Items can be answered on a eleven-step numeric rating scale (0-10). Items are analyzed individually.

COPD Assessment Test (CAT)

Questionnaire: Impact of COPD on health status The questionnaire consists of eight questions that can be answered on a six-point likert scale (0-5). All answers are added up to determine the overall score (0 to 40). Higher scores indicate that COPD has more impact on the participant's life.

St. Georges Respiratory Questionnaire (SGRQ) (4 weeks)

Questionnaire: Overall health, daily life, and perceived well-being in patients with obstructive airways disease The questionnaire consists of 52 items. The overall score ranges from 0-100, with higher scores indicating more limitations.

Patient Health Questionnaire (PHQ-9)

Questionnaire: Depression The questionnaire consists of 9 items that can be answered on a 4-point likert scale (0-3 points). Answers are added to a sum score, with higher scores indicating higher depression levels.

COPD-Anxiety Questionnaire (CAF-R)

Questionnaire: COPD specific fears The CAF-R consists of 20-items that are rated on a 5-point Likert-type scale (0= never to 4=always). Five scales can be built: fear of dyspnea, fear of physical activity, fear of progression, fear of social exclusion, and sleep-related worries. Additionally, an overall score can be calculated (sum of all items).

Physical activity-related health competence questionnaire

42-item questionnaire that measures physical activity-related health competence. The physical activity related health competence consists of three subcompetencies: movement competence (18 items), control competence (10 items), physical activity-related self-regulation competence (14 items). Scores for each subcompetence can be calculated as sum scores, mean scores, or percentages. Higher scores indicate higher levels of the subcompetences.

BSA-Questionnaire

Questionnaire: Subjectively measured physical activity The questionnaire asks for physical activities during a typical week. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report frequency and duration of activities executed during the last two 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 in order to receive the overall volume of physical activity completed during leisure-time and transportation as well as sport-/exercise-related activities.

Bief Fatigue Inventory (BFI)

Questionnaire: Fatigue The BFI starts with a question asking the patient whether he feels more than usual fatigued or tired (yes/no). This question is followed by nine items on the intensity of fatigue as well as impairments caused by fatigue. These questions can be answered on an eleven-step numerical rating scale (0-10), with higher scores indicating higher intensity and impairment. The total BFI score is the mean of the nine items.

Health Care Climate Questionnaire (German version) (HCCQ-D)

Questionnaire: patients' perceived autonomy support from their health care provider The questionnaire consists of 15 items that can be answered on a seven-point Likert scale (1=strongly disagree, 7=strongly agree). An overall score is calculated by taking the average of individual item scores.

Usability and usefulness of the mobile application (meCue 2.0 questionnaire)

The module usability and usefulness of the meCue 2.0 questionnaire was used. The module contains 3 items on usability and 3 items on usefulness that are answered on a 7-point Likert scale (scored from 1 to 7). In order two receive a score for usability and a score for usefulness, the mean is calculated for the items of each area

Full Information

NCT ID

NCT05006560

First Posted

July 31, 2021

Last Updated

April 26, 2022

Sponsor

University of Erlangen-Nürnberg

Collaborators

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance

1. Study Identification

Unique Protocol Identification Number

NCT05006560

Brief Title

Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD

Acronym

COPD-AReNa

Official Title

An Internet-based Rehabilitation Aftercare Program Focusing on Physical Activity Promotion for Persons With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 5, 2021 (Actual)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Erlangen-Nürnberg

Collaborators

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate a 12-week internet-based rehabilitation aftercare program with an emphasis on physical activity promotion for persons with COPD. The program starts directly after an inpatient pulmonary rehabilitation program. It includes monitoring and promotion of physical activity, progressive resistance and endurance training, education through online learning modules and continuous support from a therapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive, exercise, physical activity promotion, behavior change, internet-based intervention, physical literacy, rehabilitation aftercare, mhealth, telerehabilitation, feasibility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual care rehabilitation and aftercare

Arm Type

Experimental

Arm Description

Participants receive the standard inpatient pulmonary rehabilitation followed by an internet based 12-week rehabilitation aftercare program.

Arm Title

Rehabilitation and aftercare (aligned)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Pulmonary Rehabilitation (usual care)

Intervention Description

Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days.

Intervention Type

Other

Intervention Name(s)

Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program

Intervention Description

Intervention Type

Other

Intervention Name(s)

After care: Exercise and physical activity promotion

Intervention Description

Participants will agree with their therapist on an exercise plan (endurance and resistance training) that are made available for participants through the study's mobile app. Frequency and duration of endurance and strength training are prescribed in accordance with exercise guidelines for persons with COPD. However, they can be adjusted according to participants needs. Next to the exercise, participants receive physical activity counseling. This consists of phone or video calls with a therapist, group video calls with a therapist, a complementary e-learning course as well as complementary functions of the study's mobile app.

Primary Outcome Measure Information:

Title

Acceptability of the intervention and participants' satisfaction (participant perspective)

Description

Semi-structured interviews will be conducted with persons with COPD that participated in the study.

Time Frame

one week after the rehabilitation aftercare program (T2)

Title

Acceptability and practicability of intervention (therapist perspective)

Description

Semi-structured interviews will be conducted with therapists that delivered the intervention.

Time Frame

one week after the last participant was supervised by the therapist

Title

Recruitment

Description

Number of participants screened, number of eligible participants, number of participants recruited, reasons for exclusion during recruitment

Time Frame

6 to 3 weeks prior to inpatient rehabilitation

Title

Compliance with intervention protocol

Description

Completed training sessions, e-learning modules and telephone calls with the therapist will be documented for each participant.

Time Frame

from the start of the aftercare program, until the end of the aftercare program, on average 12 weeks

Title

Retention

Description

Percentage of included participants that complete T2 assessment.

Time Frame

one week after the rehabilitation aftercare program (T2)

Secondary Outcome Measure Information:

Title

Dyspnea, cough, sputum, pain

Description

Questionnaire: Numeric Rating Scales (self-developed) The questionnaire consists of seven items. Items can be answered on a eleven-step numeric rating scale (0-10). Items are analyzed individually.

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

COPD Assessment Test (CAT)

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

St. Georges Respiratory Questionnaire (SGRQ) (4 weeks)

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

Patient Health Questionnaire (PHQ-9)

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

COPD-Anxiety Questionnaire (CAF-R)

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

Physical activity-related health competence questionnaire

Description

Time Frame

During the first week of pulmonary rehabilitation (T0), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

BSA-Questionnaire

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

Bief Fatigue Inventory (BFI)

Description

Time Frame

Two weeks prior to inpatient rehabilitation (T-1), during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

Health Care Climate Questionnaire (German version) (HCCQ-D)

Description

Time Frame

during the last week of pulmonary rehabilitation (T1), one week after the rehabilitation aftercare program (T2)

Title

Usability and usefulness of the mobile application (meCue 2.0 questionnaire)

Description

Time Frame

during the last week of pulmonary rehabilitation (T1) (only intervention group), one week after the rehabilitation aftercare program (T2)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications A-D and stages 1-4. Internet access at home owning a smartphone with the operating system Android or iOS basic computer and internet skills (e. g. using web browser) ability to operate a smartphone (especially to install mobile applications) ability to read, write and comprehend as well as communicate electronically Exclusion Criteria: severe concomitant disease, which will affect the ability to be physically active more than COPD for example, cancer or severe cardiac, neurological, orthopaedic or metabolic comorbidities) cognitive impairment that hampers study implementation Lack of ability to speak German

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Verena Hartung, M. A.

Phone

004991318528175

verena.vh.hartung@fau.de

First Name & Middle Initial & Last Name or Official Title & Degree

Klaus Pfeifer, Prof. Dr.

Phone

004991318525465

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

First Name & Middle Initial & Last Name & Degree

Konrad Schultz, Dr. med.

Organizational Affiliation

Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics German Statutory Pension Insurance

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik Bad Reichenhall der Deutschen Rentenversicherung Bayern Süd

City

Bad Reichenhall

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Limbach

Phone

004986517094957

matthias-peter.limbach@klinik-bad-reichenhall.de

12. IPD Sharing Statement

Learn more about this trial

Internet-based Rehabilitation Aftercare Focusing on Physical Activity Promotion in Persons With COPD

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