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| ID | Type | Description | Link |
|---|---|---|---|
| REK2024/733856 | Other Identifier | Western Norway Regional Committees for Medical and Health Research Ethics |
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| Name | Class |
|---|---|
| Helse Forde | OTHER |
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Dyspnea, cough, and chronic mucus hypersecretion are common symptoms in patients with Chronic Obstructive Pulmonary Disease (COPD), which increases risk of infections followed by exacerbations, often leading to hospitalization, disease progression and mortality. This patient group requires lifelong treatment in healthcare. A mobile application was developed to facilitate adherence to evidence-based guidelines for tailored breathing and airway clearance techniques to enhance self-management. The app is only in Norwegian and has a Norwegian name which is "Pust Deg Bedre" (PDB). The PDB app is fully developed and tested and can be downloaded for free. The app seems promising as a treatment tool, but has not yet been clinical evaluated. This project aims to 1) explore the feasibility of providing the app for patients with COPD, 2) explore the patients' with COPD experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 3) explore the physiotherapists' experiences with the use of the PDB-app in treating dyspnea and mucus secretion, 4) explore the physiotherapists' experiences with implementing the PDB-app in treatment of patients with COPD, 5) explore the patients' experiences with the education in use of the PDB-app, and 6) At a 6-month follow up: explore the physiotherapists experiences with the usefulness and applicability of PBD-app, and to generally explore their experiences with participating in the project.
This project is designed to explore aspects of acceptability and possible uncertainties associated with implementing the PDB-app as part of self-management in patients with COPD. Both quantitative and qualitative data will be collected and analysed.
50-60 patients with COPD and 15-30 physiotherapists in primary health care will be recruited.
A feasibility study will be conducted and evaluated after 8-week intervention and at 6-month follow-up, using a pre-post design.
Intervention: The physiotherapists will be responsible for providing the patients with training on the use of the PDB-app. Based on clinical assessment, the patients will receive a tailored treatment plan within the app. Patients are expected to engage with the tailored PDB-treatment for 8 weeks with follow-up after 6 months. If necessarily, adjustments to the treatment plan will be made throughout the intervention period. Follow-up of patients will occur digitally and physically.
A qualitative interview study will be conducted with semi-structured interviews after 8 weeks of intervention for a deeper understanding of the patients' and physiotherapists' experiences with the PDB-app. Separate focus groups will be conducted with the patients and the physiotherapists.
The investigators will also conduct video-recorded physiotherapy sessions at two time points during the intervention. The first one during the initial session, and then again between 3 to 6 weeks during the 8-week intervention. Subsequently, in-depth interviews, using Interpersonal Process Recall (IPR), will be conducted, with the researcher and physiotherapist, and with the researcher and patient. By using IPR interviews, video-assisted recall will help research participants access underlying experiences of their recent clinical interactions and put them into words. This means that the interaction between patient, physiotherapist and the PDB-app, experienced and recalled in the interview, relates to concrete events of the specific session.
Targeting physiotherapists, the investigators aim to do a long-term follow up 6 months after the intervention and explore their experiences with having participated in IPR interviews and as participants in the study in general. How and to what degree has the IPR interview sessions and the experiences from participating in this project impacted on their clinical practice, perception of role, identity and lifeworld? The investigators will conduct individual semi-structured qualitative interviews with all the physiotherapists from the IPR interviews.
Criteria for success:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital health intervention group | Experimental | Patients with COPD will use the mobile-app in self-management of treating dyspnea and mucus secretion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital health intervention by using a mobile application | Device | A digital health intervention for promoting self-management in patients with COPD by using a mobile application. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate (n, %) | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Intervention adherence | Intervention adherence (n, %) | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Adverse events | Adverse events (n, %) | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Dropout rate | Dropout (n, %) | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcomes | - Dyspnea-12 (D-12) scale score (score 0-36) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcomes | Modified Medical Research Council dyspnea scale (mMRC) (score 0-4) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcomes | Chalder Fatigue Scale (CFQ-11) (score 0-33) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bente Frisk, PHD | Contact | 0047- 55587143 | bente.frisk@hvl.no | |
| Siri Dahl Aune, MSc | Contact | 0047-46417431 | siri.dahl.aune@hvl.no |
| Name | Affiliation | Role |
|---|---|---|
| Bente Frisk, PHD | Western Norway University of Applied Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Norway University of Applied Sciences | Recruiting | Bergen | Norway | 5063 | Norway |
In accordance with the approvals granted for this study by the Regional Committee on Medical Research Ethics and the Norwegian Data Inspectorate, the data files will be stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data will be made available to interested researchers upon reasonable request to Bente Frisk: bente.frisk@hvl.no, providing that Norwegian privacy legislation and the General Data Protection Regulation are respected, and that permission is granted from the Norwegian Data Inspectorate and the data protection officer at Western Norway University of Applied Sciences.
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Will be available after data completion of the study: 31.12.30
In accordance with the approvals granted for this study by the Regional Committee on Medical Research Ethics and the Norwegian Data Inspectorate, the data files will be stored securely and in accordance with the Norwegian Law of Privacy Protection. A subset of the data file with anonymized data will be made available to interested researchers upon reasonable request to Bente Frisk: bente.frisk@hvl.no, providing that Norwegian privacy legislation and the General Data Protection Regulation are respected, and that permission is granted from the Norwegian Data Inspectorate and the data protection officer at Western Norway University of Applied Sciences.
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The investigators will use the mobile app "Pust Deg Bedre" to explore the feasibility and experiences of providing PDB for patients with COPD,
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| Feasibilty study and qualitative interview studies | Other | This study is a one group feasibility study including quantitative and qualitative study designs. The investigators will use focus groups and indiviual interviews, as well as Interpersonal Process Recall (IPR) interviews. |
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| Health related outcomes | COPD Assessment Test (CAT) (score 0-40) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcome | Generalized Anxiety Disorder Assessment (GAD-7) (score 0-21) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcome | Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcomes | Patient Health Questionnaire-9 (PHQ-9) (score 0-27) - low score indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health related outcomes | EuroQol Questionnaire (EQ-5D) (index and VAS score 0-100) Index: An overall score is generated, ranging from <0 to 1. Low score indicates worse outcome VAS score: low score indicates worse outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Physical functioning | 60 seconds Sit-To-Stand (60sSTS) (number of repetitions) - Higher number of repetitions indicates better outcome | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Exacerbations, hospital admissions and use of healthcare services | The number of exacerbations, hospital admissions and use of healthcare services (n) | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health literacy | Health Literacy Questionnaire (HLQ) (44 items, 9 domains) - Health literacy was measured using three domains of the HLQ; 3) Actively managing my health, 6) Ability to engage actively with health-care providers and 9) Understand health information well enough to know what to do. Domains 1-5 are scored 1-4, and domains 6-9 are scored 1-5. Lower score indicates lower levels of health literacy. | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health literacy | E-Health Literacy Questionnaire (e-HLQ) (35 items, 7 domains) - E-Health literachy was measured using two domains of the e-HLQ; 3) Ability to actively engage with digital services and 5) Motivated to engage with digital services. Scores range from 1-4. Lower score indicates lower levels of e-Health literacy. | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Health education and self-management | Health Education Impact Questionnaire (heiQ) (48 items, 8 domains) - is used to measure helath edcuation and self-management. We are using three domains of the heiQ; 2) Health related behaviour, 3) Skill and technique acquisition and 5) Self-monitoring and insight. Scores ranges from 1-4. Lower score indicates lower levels of health education impact and self-management. | From enrollment to end of the treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Satisfaction with treatment | Patients Global Impression of Change (PGIC) (score 0-7) - low score indicates better outcome | End of treatment at 8 weeks and the end of treatment at 6-month follow-up |
| Satisfaction with treatment | Client Satisfaction Questionnaire (CSQ-8) (score 8-32) - low score indicates worse outcome | End of treatment at 8 weeks and the end of treatment at 6-month follow-up |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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