A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF
Open accessAbstract
BACKGROUND: The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies. METHODS: This is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms. DISCUSSION: This study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF. TRIAL REGISTRATION: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642 ).
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All five ongoing trials are two-arm RCTs; three compare psychological intervention to usual care, one compares ACT to supportive psychotherapy.
“All five ongoing trials are two-arm RCTs, with three trials comparing a psychological intervention to usual care (Phan 2021; Thee 2021; White 2017), and one trial comparing a psychological intervention (Acceptance and Commitment Therapy; ACT) with an active comparator arm (Supportive Psychotherapy) (O'Hayer 2019).”
From Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis (2023) · cites this paper as Thee 2021
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- Authors
- Thee, S., Stahl, M., Fischer, R., Sutharsan, S., Ballmann, M., Müller, A., Lorenz, D., Urbanski-Rini, D., Püschner, F., Amelung, V. E., Fuchs, C., & Mall, M. A.
- Affiliations
- Charité – Universitätsmedizin Berlin (DE)
- German Center for Lung Research (DE)
- Ludwig-Maximilians-Universität München (DE)
- Ruhrlandklinik (DE)
- Universitätsmedizin Rostock (DE)
- PARI (Germany) (DE)
- Corresponding author
- Mall, Marcus Alexander
- ORCID
- Venue
- BMC Pulmonary Medicine
- Published
- 2021-04-21
- Volume
- 21
- Issue
- 1
- Pages
- 131-131
- ISSN
- 1471-2466 (ISSN-L)
- PMC
- PMC8058751
- OpenAlex
- W3154957249
- Cited by
- 25
- References
- 48
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 2 · 2023: 10 · 2022: 4 · 2021: 2
- FWCI
- 2.91
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Pulmonary Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Informationszentrum Lebenswissenschaften (ZB MED) (submittedVersion, cc-by)
- Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by)
- Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver (cc-by)
- Funders
- German Innovation Fund (01NVF19008)
- Charité
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cystic Fibrosis Research Advances
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- cystic fibrosis, remote patient monitoring, medication adherence, inhalation therapy, pulmonary exacerbations, home spirometry, telemedicine, behaviour change interventions, self-management apps, telephone coaching, lung function, health-related quality of life, hospitalization, health care costs
- MeSH terms
- Adolescent, Adult, Child, Cystic Fibrosis, Humans, Patient Education as Topic, Telemedicine, Monitoring, Ambulatory
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