Dataset Information

A randomized controlled trial of a literacy-sensitive self-management intervention for chronic obstructive pulmonary disease patients.

ABSTRACT:

Background

Low literacy skills are common and associated with a variety of poor health outcomes. This may be particularly important in patients with chronic illnesses such as chronic obstructive pulmonary disease (COPD) that require appropriate inhaler technique to maintain quality of life and avoid exacerbations.

Objective

To explore the impact of a literacy-sensitive self-management intervention on inhaler technique scores in COPD patients and to determine if effects differ by literacy.

Design

Randomized controlled trial.

Participants

Ninety-nine patients with COPD.

Intervention

Patients were randomly assigned to a one-on-one self-management educational intervention or usual care. The intervention focused on inhaler technique, smoking cessation, and using a COPD action plan.

Main measures

At baseline, an inhaler technique assessment, literacy assessment, health-related quality of life questionnaires, and pulmonary function tests were completed. Inhaler technique was re-evaluated after two to eight weeks.

Key results

Mean age 63, 65% female, 69% Caucasian, moderate COPD severity on average, 36% with low literacy, moderately impaired health-related quality of life, and similar baseline metered dose inhaler technique scores. Patients in the intervention group had greater mean improvement from baseline in metered dose inhaler technique score compared to those in the usual care group (difference in mean change 2.1, 95% CI 1.1, 3.0). The patients in the intervention group also had greater mean improvements in metered dose inhaler technique score than those in the usual care group whether they had low health literacy (difference in mean change 2.8, 95% CI 0.6, 4.9) or higher health literacy (1.8, 95% CI 0.7, 2.9).

Conclusions

A literacy-sensitive self-management intervention can lead to improvements in inhaler technique, with benefits for patients with both low and higher health literacy.

SUBMITTER: Kiser K

PROVIDER: S-EPMC3270237 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Publications

A randomized controlled trial of a literacy-sensitive self-management intervention for chronic obstructive pulmonary disease patients.

Kiser Katie K Jonas Daniel D Warner Zachary Z Scanlon Kelli K Shilliday Betsy Bryant BB DeWalt Darren A DA

Journal of general internal medicine 20110921 2

<h4>Background</h4>Low literacy skills are common and associated with a variety of poor health outcomes. This may be particularly important in patients with chronic illnesses such as chronic obstructive pulmonary disease (COPD) that require appropriate inhaler technique to maintain quality of life and avoid exacerbations.<h4>Objective</h4>To explore the impact of a literacy-sensitive self-management intervention on inhaler technique scores in COPD patients and to determine if effects differ by l ...[more]

PMID: 21935752

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Project description:BACKGROUND:Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared. OBJECTIVE:This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group. METHODS:We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital. RESULTS:A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits. CONCLUSIONS:Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology. TRIAL REGISTRATION:ClinicalTrials.gov NCT03741855; https://clinicaltrials.gov/ct2/show/ NCT03741855.

Project description:BackgroundThe application of telemedicine in home pulmonary rehabilitation interventions for the management of patients with chronic obstructive pulmonary disease (COPD) has achieved promising results.ObjectiveThis study aimed to develop a WeChat official account (Pulmonary Internet Explorer Rehabilitation [PeR]) based on social media. It further evaluated the effect of PeR on the quality of life, symptoms, and exercise self-efficacy of patients with COPD.MethodsThe functional modules of PeR were developed by a multidisciplinary team according to the electronic health-enhanced chronic care model (eCCM) components. A total of 106 patients were randomly selected (53 in the PeR group and 53 in the outpatient face-to-face group [FtF]). Pulmonary rehabilitation intervention was conducted for 3 months, and the outcome was observed for 3 months. The primary outcome was patient quality of life measured with the COPD assessment test (CAT). The secondary outcomes were evaluated using the modified Medical Research Council scale (mMRC), exercise self-regulatory efficacy scale (Ex-SRES), and St George's Respiratory Questionnaire (SGRQ).ResultsThe intention-to-treat analysis was used in the study. A total of 94 participants completed the 6-month pulmonary rehabilitation program. No statistically significant differences were observed in CAT (F1,3=7.78, P=.001), Ex-SRES (F1,3=21.91, P<.001), and mMRC scores (F1,3=29.64, P<.001) between the two groups with the variation in time tendency. The Ex-SRES score had a significant effect on the CAT score (P=.03). The partial regression coefficient of Ex-SRES to CAT was 0.81, and Exp (B) was 2.24.ConclusionsThe telemedicine technology was effective using the eCCM combined with a behavioral intervention strategy centering on self-efficacy. Pulmonary rehabilitation at home through PeR and FtF could improve the sense of self-efficacy and quality of life and alleviate symptoms in patients with COPD.Trial registrationChinese Clinical Trial Registry ChiCTR1900022770; https://tinyurl.com/tmmvpq3.

Project description:RationalePhysical inactivity is associated with poor outcomes among patients with chronic obstructive pulmonary disease (COPD).ObjectivesTo determine effectiveness of a behavioral intervention intended to increase daily physical activity with the goal of improving health-related quality of life and functional performance.MethodsWe conducted a randomized trial among patients with COPD cared for in primary care and pulmonary clinics. The patients were at least 45 years of age and eligible for pulmonary rehabilitation. All patients received self-management education during a 6-week run-in period. Subsequently, patients were randomized to usual care or the intervention delivered over 20 weeks.Measurements and main resultsCo-primary outcomes were change from baseline in Chronic Respiratory Questionnaire dyspnea domain score and 6-minute-walk distance measured at 6, 12, and 18 months after randomization. A total of 325 patients were enrolled, with 156 randomized to receive usual care and 149 to receive the intervention. At 18 months, there was no overall statistical or clinically significant change in the dyspnea domain in either group. However, for 6-minute-walk distance, there were statistically significant declines in both groups. In contrast, 6-minute-walk distance remained stable (5.3 m; P = 0.54) among patients in the intervention group with moderate spirometric impairment, but it was associated with clinically and statistically significant declines (-28.7 m; P = 0.0001) among usual care patients with moderate spirometric impairment. Overall, there was no increase in adverse events associated with the intervention, which was associated with a lower prevalence of hospitalization for COPD exacerbations (28.3%) compared with usual care (49.5%).ConclusionsDuring this 18-month trial among outpatients with COPD, a health coach-based behavioral intervention did not improve scores in the dyspnea domain of the Chronic Respiratory Questionnaire or 6-minute-walk test distance. However, subgroup analyses suggested that there may be differential effects for specific outcomes that vary with severity of COPD. Specifically, benefits of this low-intensity intervention may be limited to 6-minute walk distance among patients with moderate spirometric impairment. Clinical trial registered with www.clinicaltrials.gov (NCT1108991).

Project description:BACKGROUND:Many patients with chronic obstructive pulmonary disease (COPD) suffer from exacerbations, a worsening of their respiratory symptoms that warrants medical treatment. Exacerbations are often poorly recognized or managed by patients, leading to increased disease burden and health care costs. OBJECTIVE:This study aimed to examine the effects of a smart mobile health (mHealth) tool that supports COPD patients in the self-management of exacerbations by providing predictions of early exacerbation onset and timely treatment advice without the interference of health care professionals. METHODS:In a multicenter, 2-arm randomized controlled trial with 12-months follow-up, patients with COPD used the smart mHealth tool (intervention group) or a paper action plan (control group) when they experienced worsening of respiratory symptoms. For our primary outcome exacerbation-free time, expressed as weeks without exacerbation, we used an automated telephone questionnaire system to measure weekly respiratory symptoms and treatment actions. Secondary outcomes were health status, self-efficacy, self-management behavior, health care utilization, and usability. For our analyses, we used negative binomial regression, multilevel logistic regression, and generalized estimating equation regression models. RESULTS:Of the 87 patients with COPD recruited from primary and secondary care centers, 43 were randomized to the intervention group. We found no statistically significant differences between the intervention group and the control group in exacerbation-free weeks (mean 30.6, SD 13.3 vs mean 28.0, SD 14.8 weeks, respectively; rate ratio 1.21; 95% CI 0.77-1.91) or in health status, self-efficacy, self-management behavior, and health care utilization. Patients using the mHealth tool valued it as a more supportive tool than patients using the paper action plan. Patients considered the usability of the mHealth tool as good. CONCLUSIONS:This study did not show beneficial effects of a smart mHealth tool on exacerbation-free time, health status, self-efficacy, self-management behavior, and health care utilization in patients with COPD compared with the use of a paper action plan. Participants were positive about the supportive function and the usability of the mHealth tool. mHealth may be a valuable alternative for COPD patients who prefer a digital tool instead of a paper action plan. TRIAL REGISTRATION:ClinicalTrials.gov NCT02553096; https://clinicaltrials.gov/ct2/show/NCT02553096.

Project description:ObjectiveTo assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice.Design24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial.Setting15 general practices in the eastern part of the Netherlands.ParticipantsPatients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded.InterventionsA comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative).Outcome measuresThe primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale.Results165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58).ConclusionsComprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group.Trial registrationClinical trials NCT00128765.

Dataset Information

A randomized controlled trial of a literacy-sensitive self-management intervention for chronic obstructive pulmonary disease patients.

Background

Objective

Design

Participants

Intervention

Main measures

Key results

Conclusions

Publications

A randomized controlled trial of a literacy-sensitive self-management intervention for chronic obstructive pulmonary disease patients.

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