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Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

ABSTRACT: INTRODUCTION:The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. ETHICS AND DISSEMINATION:Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT02696187.

SUBMITTER: Nyberg A

PROVIDER: S-EPMC5642786 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

Nyberg André A Wadell Karin K Lindgren Helena H Tistad Malin M

BMJ open 20170801 7

<h4>Introduction</h4>The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of th ...[more]

PMID: 28765136

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Project description:IntroductionThe use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) may increase the level of physical activity (PA), improve health-related quality of life (HRQoL) and reduce healthcare use. Whether web-based support in addition to prompts (email and SMS) could be used to promote self-management strategies to facilitate behaviour change in people with COPD is not clear. This clinical trial aims to generate evidence on the effect of a web-based solution, the COPD Web, in a cohort of people with COPD in a primary healthcare context.Methods and analysisThe overall design is a pragmatic randomised controlled trial with preassessments and postassessments (3 and 12 months) and an implementation and user experience evaluation. People with a diagnosis of COPD, treated in primary healthcare will be eligible for the study. A total of 144 participants will be enrolled through advertisment or by healthcare professionals at included primary healthcare units and, after fulfilled baseline assessment, randomised to either control or intervention group. All participants will receive usual care, a pedometer and a leaflet about the importance of PA. Participants in the intervention will, in addition, get access to the COPD Web, an interactive self-managed website that aims to support people with COPD in self-management strategies. They will also continuously get support from prompts with a focus on behaviour change.The effect on participants' PA, dyspnoea, COPD-related symptoms, HRQoL and health economics will be assessed using accelerometer and questionnaires. To identify enablers and barriers for the use of web-based support to change behaviour, semistructured interviews will be conducted in a subgroup of participants at the 3 months follow-up.Ethics and disseminationEthical approval has been received from the Regional Ethical Review Board in Umeå, Sweden. Dnr 2018-274 and dnr 2019-05572. Findings will be presented at conferences, submitted for publication in peer-reviewed journals and presented to the involved healthcare professionals, participants and patient organisations.Trial registration numberNCT03746873.

Project description:BackgroundUse of the Internet for people with Long Term Conditions (LTCs) can have a positive effect on knowledge, social support, behavioural and clinical outcomes, yet there is concern that a 'digital divide' prevents some patients from benefitting. While some patients do not have access to the Internet, others that do may still lack expertise or the confidence to make full use of it. The aim of this pilot study was to develop an intervention and test methods for a definitive randomised controlled trial (RCT) of anonymous personal online email support for patients in this latter group.MethodsRecruitment success was evaluated by the number and appropriateness of participants recruited. A personalised e-health support intervention was developed. The provisional primary outcome was the extent to which the Internet affected the participants' confidence in dealing with their LTC. Primary outcome, seven process measures and two secondary outcomes measures were evaluated for completeness of data and sensitivity to detect changes.ResultsThirty nine participants were recruited, 29 after personally receiving a leaflet, seven via email advertising, and three via leaflets left in waiting areas. Most participants (61%) were aged over 60. The majority (21/38) rated themselves as experienced Internet users although only 5/38 had used discussion forums for their LTC. Piloting the intervention identified support needed as: (i) technical help with some websites, (ii) advice about issues such as anonymity, (iii) help in judging information quality, (iv) identification of relevant information (via 'Information Prescriptions'), (v) motivational support to try new sites. Attrition was fairly high: 20/39 completed follow up questionnaires. Three process measures showed ceiling effects and two had too many missing values to be useable.ConclusionE-health support is a promising way of addressing the problems faced by older generation e-health seekers. Face-to-face leaflet distribution recruited sufficient numbers but additional locations other than hospital should be tried to recruit Internet novices with LTCs. An RCT is feasible and necessary to evaluate the potential benefits of anonymous email support. Our methods could be used by other researchers studying Internet use by people with LTCs.

Project description:PurposeWe aimed to compare the efficacy, safety, and cost-effectiveness of non-pharmacological- and pharmacological treatment strategies for Lumbar disc herniation (LDH) in pragmatic clinical settings.Patients and methodsThis study was a pilot, two-armed, parallel pragmatic randomized controlled trial. Thirty patients aged 19-70 years with a numeric rating scale (NRS) score ≥5 for sciatica and confirmed LDH on magnetic resonance imaging (MRI) were included. Participants were assigned in a 1:1 ratio to non-pharmacological (non-Phm) or pharmacological (Phm) treatment group. They were treated for 8 weeks and a total follow-up period was 26 weeks after randomization. Non-Phm treatment included acupuncture, spinal manual therapy, etc., Phm included medication, injection, nerve block, etc., The primary outcome was a numeric rating scale (NRS) of radiating leg pain. NRS for low back pain, Oswestry disability index, visual analog scale, Fear-Avoidance Beliefs Questionnaire, patient global impression of change, Short Form-12 Health Survey, version 2, 5-level European Quality of Life-5 dimensions (EQ-5D) were also measured. Linear mixed model was used to evaluated the difference in change of outcomes from baseline between two groups. An economic evaluation was conducted using incremental cost-effectiveness ratios.ResultsThere was no significant difference between the two groups in the intervention period, but non-Phm group showed significantly greater degree of improvement in follow-up of Week 14. Difference in the NRS for sciatica and ODI were 1.65 (95% CI 0.59 to 2.71, p=0.003) and 8.67 (95% CI 1.37 to 15.98, p=0.21), respectively in Week 14. The quality-adjusted life year (QALY) value calculated by EQ-5D and Short Form-6 Dimension were 0.006 (95% CI -0.012 to 0.024, p=0.472) and 0.015 (95% CI -0.008 to 0.038, p=0.195) higher in non-Phm group than in Phm group. The cost was lower in non-Phm group than in Phm group (Difference: -682, 95% CI -3349 to 1699, p=0.563).ConclusionWe confirmed that the non-Phm treatment could be more cost-effective treatments than Phm treatments and feasibility of a large-scale of main study in future.

Project description:BackgroundClinicians need to be able to assess the quality of the available information to aid clinical decision-making. The internet has become an important source of health information for consumers and their families.ObjectiveThis study aimed to rate the quality of websites with psychosis-related information (to provide clinicians with a basis for recommending material to guide clinical decision-making with consumers and their families), using a validated instrument as well as a purpose-developed checklist, and consider improvement in quality over a 4-year period.MethodsTwo measures of website quality were used: the DISCERN scale and the Psychosis Website Quality Checklist (PWQC). Terms related to psychosis, including "psychotic," "psychosis," "schizophrenia," "delusion," and "hallucination," were entered into Google, and the first 25 results were analyzed. In total, 6 raters with varying health professional backgrounds were used to evaluate the websites across two time points: January-March 2014 and January-March 2018.ResultsOf the 25 websites rated, only the 6 highest ranked websites achieved a DISCERN score, indicating that they were of "good" quality (51-62 out of a possible 75), while the mean score of the websites (mean 43.96, SD 12.08) indicated an overall "fair" quality. The PWQC revealed that websites scored highly on "availability and usability" (mean 16.82, SD 3.96) but poorly on "credibility" (mean 20.99, SD 6.68), "currency" (mean 5.16, SD 2.62), and "breadth and accuracy" (mean 77.87, SD 23.20). Most sites lacked information about early intervention, recreational drug use and suicide risk, with little change in content over time. Stating an editorial or review process on the website (found in 56% of websites) was significantly associated with a higher quality score on both scales (the DISCERN scale, P=.002; the PWQC, P=.006).ConclusionsThe information on the internet available for clinicians to recommend to people affected by psychosis tended to be of "fair" quality. While higher-quality websites exist, it is generally not easy way to assess this on face value. Evidence of an editorial or review process was one indicator of website quality. While sites generally provided basic clinical information, most lacked material addressing weighing up risks and benefits of medication and alternatives, the role of coercive treatment and other more contentious issues. Insufficient emphasis is placed on detailed information on early intervention and importance of lifestyle modifications or how families and friends can contribute. These are likely to be the very answers that consumers and carers are seeking and this gap contributes to unmet needs among this group. We suggest that clinicians should be aware of what is available and where there are gaps.

Project description:BackgroundCOPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.Methods and designTwenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.DiscussionsThis study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.Trial registrationName of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019.

Project description:BackgroundPulmonary rehabilitation is an important component of chronic disease management in chronic obstructive pulmonary disease (COPD) and has been shown to improve shortness of breath, exercise capacity, quality of life, and decrease hospitalizations. However, pulmonary rehabilitation capacity is low. Primary care may be an effective method for delivering disease management services to this population. The objective of this feasibility pragmatic clinical trial was to evaluate enrollment and completion of a primary care network exercise and education program for people with COPD.MethodsCOPD patients (N = 23; mean age = 65 ± 9 years; FEV1 = 68 ± 20% predicted) were recruited after referral to a primary care network exercise program in Edmonton, Alberta. Participants self-selected either an 8-week 16-session supervised exercise program or an 8-week unsupervised exercise program where they received three visits with an exercise specialist. Both groups self-selected education sessions with clinicians for disease management support. Referrals, completion, and program outcomes (physical activity, exercise capacity and health status) were measured before (T1), immediately after (T2), and 8 weeks following the program (T3).ResultsForty-three referrals were received in 10 months, where a minimum of 50 was required in order for the program to be considered feasible. Twenty-three participants provided baseline data, and twenty participants started the exercise program (10 in each exercise group), 16 of which completed the exercise program (80%). On average, 48% of the recommended education sessions were completed by participants.ConclusionsEnrollment into a COPD exercise and education program in a primary care network was low indicating the need for improved referral processes from physicians. Completion rates by participants were adequate for exercise but not education. The low referral rate and the lack of enrollment in COPD education by the patients indicate that a large-scale trial of the program as designed is not feasible.

Dataset Information

Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

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Internet-based support for self-management strategies for people with COPD-protocol for a controlled pragmatic pilot trial of effectiveness and a process evaluation in primary healthcare.

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