Efficacy of a multifactorial intervention on therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): a randomized controlled trial
Open accessAbstract
BACKGROUND: Therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is poor. This study evaluated the effectiveness of a multifactorial intervention on improving the therapeutic adherence in chronic obstructive pulmonary disease (COPD) patients with scheduled inhalation therapy. METHODS: The study design consisted of a randomised controlled trial in a primary care setting. 146 patients diagnosed with COPD were randomly allocated into two groups using the block randomisation technique. One-year follow-ups with three visits were performed. The intervention consisted of motivational aspects related to adherence (beliefs and behaviour) in the form of group and individual interviews, cognitive aspects in the form of information about the illness and skills in the form of training in inhalation techniques. Cognitive-emotional aspects and training in inhalation techniques were reinforced during all visits of the intervention group. The main outcome measure was adherence to the medication regimen. Therapeutic adherence was determined by the percentage of patients classified as good adherent as evaluated by dose or pill count. RESULTS: Of the 146 participants (mean age 69.8 years, 91.8% males), 41.1% reported adherence (41.9% of the control group and 40.3% of the intervention group). When multifactorial intervention was applied, the reported adherence was 32.4% for the control group and 48.6% for the intervention group, which showed a statistically significant difference (p = 0.046). Number needed to treat is 6.37. In the intervention group, cognitive aspects increased by 23.7% and skilled performance of inhalation techniques increased by 66.4%. The factors related to adherence when multifactorial intervention was applied were the number of exacerbations (OR = 0.66), visits to health centre (OR = 0.93) and devices (OR = 2.4); illness severity (OR = 0.67), beta-2-adrenergic (OR = 0.16) and xantine (OR = 0.19) treatment; activity (OR = 1.03) and impact (OR = 1.03) scales of the Saint George Respiratory Questionnaire. CONCLUSION: Application of the multifactorial intervention designed for this study (COPD information, dose reminders, audio-visual material, motivational aspects and training in inhalation techniques) resulted in an improvement in therapeutic adherence in COPD patients with scheduled inhalation therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN18841601.
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The study will require 150 subjects based on statistical analysis, with recruitment between 128 and 172 depending on statistical power.
“Based on statistical analysis, preventive inherent power and sample size [40] we anticipate that the study will require 150 subjects. We will recruit between 128 subjects (statistical power of 0.80; α = 0.05; 1 − β = 0.80; t (126) =1.97) and 172 subjects (statistical power equal to 0.90; α = 0.05; 1 − β = 0.90; t (170) = 1.97).”
From A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial. (2017) · cites this paper as [33]
The Methods (Participants, design and setting; page not specified) reports a sample-size calculation using 80% statistical power and a 95% confidence level. It describes a COPD trial with 146 enrolled patients, but does not support the citing study’s estimate of 150 subjects or its recruitment range of 128–172 at 80–90% power. (LLM, conf=0.88)
Experimental — accuracy not yet measuredPsychosocial interventions, especially those incorporating cognitive elements, reduce psychological distress.
“This approach is supported by recent meta-analyses of controlled studies that emphasize that psychosocial interventions, especially those incorporating cognitive elements, reduce psychological distress (41) and, when based on meditative and relaxation practices, have the potential to improve physical and psychological outcomes (42).”
From Promoting Acceptance and Adherence to Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. (2022) · cites this paper as [42]
The Methods > Intervention section describes cognitive and motivational elements, but their purpose was to improve treatment adherence in patients with COPD. The Results > Intervention effectiveness and Conclusion report adherence and disease-knowledge outcomes, not a reduction in psychological distress. Searches for psychological distress, anxiety, and depression found no passage establishing the attributed effect. (LLM, conf=0.75)
Experimental — accuracy not yet measuredNo study has identified the individual psychological factors that increase the risk of rejection or improper use of NIV.
“No study has identified the individual psychological factors that increase the risk of rejection or improper use of NIV.”
From A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial. (2017) · cites this paper as [33]
The Background says COPD adherence studies have focused more on measuring adherence than on factors affecting it. The Discussion addresses motivation and incorrect inhaler use, but the passages found when searching for NIV, rejection, and psychological risk factors do not address whether any study has identified psychological predictors of NIV rejection or improper use. (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Leiva-Fernández, J., Leiva-Fernández, F., García-Ruiz, A., Prados-Torres, D., & Barnestein-Fonseca, P.
- Affiliations
- Área de Gestión Sanitaria Este de Málaga-Axarquía (ES)
- Venue
- BMC Pulmonary Medicine
- Published
- 2014-04-25
- Volume
- 14
- Issue
- 1
- Pages
- 70-70
- ISSN
- 1471-2466 (ISSN-L)
- PMC
- PMC4011779
- OpenAlex
- W1988780857
- Cited by
- 57
- References
- 56
- Citations by year
- 2025: 3 · 2024: 3 · 2023: 7 · 2022: 6 · 2021: 4 · 2020: 7 · 2019: 6 · 2018: 6 · 2017: 5 · 2016: 6 · 2015: 3 · 2014: 1
- FWCI
- 5.16
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Pulmonary Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repositorio Institucional de la Universidad de Málaga (University of Málaga) (submittedVersion, cc-by)
- Funders
- Ministerio de Ciencia e Innovación
- Instituto de Salud Carlos III
- Topics
- Health Sciences › Medicine › Family Practice › Medication Adherence and Compliance
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Chronic Obstructive Pulmonary Disease (COPD) Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacy and Medical Practices
- Keywords
- chronic obstructive pulmonary disease, medication adherence, multifactorial intervention, patient education, motivational interviewing, primary care, inhaler devices, exacerbations, St George's Respiratory Questionnaire, illness beliefs, health behavior change, number needed to treat
- MeSH terms
- Assessment of Medication Adherence, Administration, Inhalation, Age Factors, Aged, Aged, 80 and over, Attitude to Health, Bronchodilator Agents, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Humans, Male, Middle Aged, Primary Health Care, Reference Values, Respiratory Therapy, Severity of Illness Index, Sex Factors, Time Factors, Odds Ratio, Treatment Outcome, Drug Monitoring, Risk Assessment, Pulmonary Disease, Chronic Obstructive, Medication Adherence
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