Personalised intervention for people with depression and severe COPD.
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ABSTRACT:
SUBMITTER: Alexopoulos GS
PROVIDER: S-EPMC3585422 | biostudies-literature | 2013 Mar
REPOSITORIES: biostudies-literature
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Personalised intervention for people with depression and severe COPD.
Alexopoulos George S GS Kiosses Dimitris N DN Sirey Jo Anne JA Kanellopoulos Dora D Novitch Richard S RS Ghosh Samiran S Seirup Joanna K JK Raue Patrick J PJ
The British journal of psychiatry : the journal of mental science 20130207 3
Chronic obstructive pulmonary disease (COPD) is often complicated by depression and exemplifies the challenge in managing chronic illnesses that require active patient participation in care. In a clinical trial (NCT00151372), we compared a novel personalised intervention for depression and COPD (PID-C) targeting treatment adherence with treatment as usual (TAU). In 138 patients with major depression and severe COPD, PID-C led to a higher remission rate and a greater reduction in depressive sympt ...[more]
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Project description:ObjectiveWe developed a personalized intervention for depressed patients with COPD (PID-C) aimed to mobilize patients to participate in the care of both conditions. We showed that PID-C reduced depressive symptoms and dyspnea-related disability more than usual care over 28 weeks. This study focused on untangling key therapeutic ingredients of PID-C.DesignRandomized controlled trial.SettingCommunity.Participants138 patients who received the diagnoses of COPD and major depression after screening 898 consecutive admissions for acute inpatient pulmonary rehabilitation.InterventionNine sessions of PID-C compared with usual care over 28 weeks.MeasurementsPrimary outcome measures were the 17-item Hamilton Depression Rating Scale and the Pulmonary Functional Status and Dyspnea Questionnaire-Modified. Other measures were adherence to rehabilitation exercise (≥2 hours per week) and adherence to adequate antidepressant prescriptions.ResultsLow severity of dyspnea-related disability and adherence to antidepressants predicted subsequent improvement of depression. Exercise and low depression severity predicted improvement of dyspnea-related disability.ConclusionsPID-C led to an interacting spiral of improvement in both depression and disability in a gravely medically ill population with a 17% mortality rate over 28 weeks and an expected deterioration in disability. The interrelationship of the course of depression and dyspnea-related disability underscores the need to target adherence to both antidepressants and chronic obstructive pulmonary disease rehabilitation. PID-C may serve as a care management model for depressed persons suffering from medical illnesses with a deteriorating course.
| S-EPMC3923856 | biostudies-literature
Project description:BACKGROUND:People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS:We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8?weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6?months; participants will be followed up to 12?months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION:The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION:ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.
| S-EPMC6945421 | biostudies-literature
Project description:BackgroundThe aim of the TANDEM trial is to evaluate whether a tailored, psychological cognitive behavioural approach intervention, which links into, and optimises the effects of routine pulmonary rehabilitation (PR), leads to a reduction in mild/moderate anxiety and/or depression in people with moderate, severe or very severe chronic obstructive pulmonary disease.Methods and designTANDEM is a multi-centre, two-arm, parallel group, pragmatic, individually randomised controlled, superiority trial including an internal pilot. Participants are randomised to receive either the intervention (a tailored psychological intervention plus usual care including referral to PR) or the control (usual care including referral to PR). The designed randomisation ratio is 1.25:1 in favour of the intervention. The multiple-primary outcomes are participant depression and anxiety at 6?months, measured using the Hospital Anxiety and Depression Scale (HADS) depression and anxiety subscales.ResultsThis article describes the statistical analysis plan (SAP) for the TANDEM trial. In particular, we describe the general analysis principles, how we will handle missing data, the primary and secondary outcomes and how these will be analysed, sensitivity analyses for the multiple-primary outcomes, and any other analyses and data summaries. The SAP was developed and published prior to completion of follow-up of the last participant.Trial registrationISRCTN registry ISRCTN59537391. Registered on 20 March 2017.
| S-EPMC7559776 | biostudies-literature
Project description:OBJECTIVE:Personalized Intervention for Depressed Patients with COPD (PID-C), a treatment mobilizing patients to participate in their care, was found more effective than usual care. To further improve its efficacy, we developed a Problem Solving-Adherence (PSA) intervention integrating problem solving into adherence enhancement procedures. We tested the hypothesis that PSA is more effective than PID-C in reducing depressive symptoms. Exploratory analyses sought to identify patients with distinct depressive symptom trajectories and compare their clinical profiles. DESIGN:Randomized controlled trial. SETTING:Acute inpatient rehabilitation and community. PARTICIPANTS:A total of 101 diagnosed with chronic obstructive pulmonary disease (COPD) and major depression after screening 633 consecutive admissions for acute inpatient rehabilitation. INTERVENTION:Fourteen sessions of PID-C versus PSA over 26 weeks. MEASUREMENTS:24-item Hamilton Depression Rating Scale. RESULTS:PSA was not more efficacious than PID-C in reducing depressive symptoms. Exploratory latent class growth modeling identified two distinct depressive symptoms trajectories. Unlike patients with unfavorable course (28%) who remained symptomatic, patients with favorable course (72%) had a decline of symptoms during the hospitalization followed by a milder decline after discharge. Patients with unfavorable course were younger and had greater scores in disability, anxiety, neuroticism, and dyspnea related limitation in activities and lower self-efficacy scores. CONCLUSIONS:Both interventions led to sustained improvement depressive symptoms. PID-C matches the skills of clinicians employed by community rehabilitation programs and can be integrated in the care of depressed COPD patients. Patients with severe disability, anxiety, neuroticism, and low self-efficacy are at risk for poor outcomes and in need of close follow-up and targeted interventions.?.
| S-EPMC5069195 | biostudies-literature
Project description:We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).
| S-EPMC6945457 | biostudies-literature
Project description:BackgroundTo our knowledge, there is no intervention which includes personalised exercise therapy and self-management support for people with multimorbidity, although these interventions may be as effective as for people with single chronic conditions. Therefore, we developed a novel intervention, including personalised exercise therapy and self-management support for people with multimorbidity.MethodsWe followed the Medical Research Council framework and conducted one scoping review, five systematic reviews, two registry-based studies, one qualitative interview study and a mixed-methods feasibility study. Following an iterative approach, together with feedback from people with multimorbidity and relevant stakeholders, we developed the MOBILIZE intervention.ResultsThe intervention included 24 (60 minutes) sessions of personalised exercise therapy and 24 (30 minutes) sessions of self-management support twice a week for 12 weeks, delivered in small groups by specifically trained physiotherapists. The intervention targets physiological, psychosocial, behavioural, and contextual factors to improve health-related quality of life and physical function in people living with multimorbidity.ConclusionsWe developed a personalised exercise therapy and self-management support programme for people with multimorbidity. The intervention will be tested for its safety and effectiveness in a randomised controlled trial.
| S-EPMC9717541 | biostudies-literature
Project description:BackgroundExercise therapy is safe and effective in people with single conditions, but the feasibility in people with two or more conditions is unclear. Therefore, the aim was to evaluate the feasibility of exercise therapy and self-management in people with multimorbidity prior to a randomised, controlled trial (RCT).MethodsThis was a mixed-methods feasibility study performed in two general hospitals and one psychiatric hospital. 20 adult patients (8 females; mean age (SD) 67 (6.9)) with at least two long-term conditions and a score of ≥ 3 on Disease Burden Impact Scale for at least one condition (at least moderate limitations of daily activities) and of ≥ 2 for at least one other condition. Patients with unstable health conditions, at risk of serious adverse events (SAE) or with terminal conditions were excluded. Participants received 12 weeks of exercise (18 60-min group-based and 6 home-based sessions) and self-management support (6 90-min group-based sessions) supervised by physiotherapists. Pre-defined progression to RCT criteria were the primary outcomes and included recruitment rate (acceptable 20 participants in 3 months), retention through follow-up (75% retention), compliance (75% complete > 9 of exercise and > 3 self-management sessions), outcome burden (80% do not find outcomes too burdensome), improvement in quality of life (EQ-5D-5L) and function (6-min walk test; ≥ 50% experience clinically relevant improvements) and intervention-related SAEs (No SAEs). Furthermore, a purposeful sample including eleven participants and two facilitators were interviewed about their experiences of participating/facilitating. Qualitative data was analysed using thematic analysis.ResultsRecruitment rate (20 in 49 days), retention (85%), outcome burden (95%), and SAEs (0 related to intervention) were acceptable, while compliance (70%) and improvements (35% in quality of life, 46% in function) were not (amendment needed before proceeding to RCT). The intervention was found acceptable by both participants and physiotherapists with some barriers among participants relating to managing multiple chronic conditions while caring for others or maintaining a job. Physiotherapists expressed a need for additional training.ConclusionsExercise therapy and self-management are feasible in people with multimorbidity. The subsequent RCT, amending the intervention according to progression criteria and feedback, will determine whether the intervention is superior to usual care alone.Trial registrationClinicalTrials.gov registration: NCT04645732 Open Science Framework https://osf.io/qk6yg/.
| S-EPMC9847074 | biostudies-literature
Project description:BackgroundExtending palliative care to those with advanced non-malignant disease is advocated, but the implications in specific conditions are poorly understood.AimsWe piloted a novel nurse-led intervention, HELPing older people with very severe chronic obstructive pulmonary disease (HELP-COPD), undertaken 4 weeks after discharge from hospital, which sought to identify and address the holistic care needs of people with severe COPD.MethodsThis 6-month mixed-method feasibility pilot trial randomised (ratio 3:1) patients to HELP-COPD or usual care. We assessed the feasibility of using validated questionnaires as outcome measures and analysed the needs/actions recorded in the HELP-COPD records. Semi-structured interviews with a purposive sample of patients, carers and professionals explored the perceptions of HELP-COPD. Verbatim transcriptions and field notes were analysed using Normalisation Process Theory as a framework.ResultsWe randomised 32 patients (24 to HELP-COPD); 19 completed the study (death=3, ill-health=4, declined=6). The HELP-COPD record noted a mean of 1.6 actions/assessment, mostly provision of information or self-help actions: only five referrals were made. Most patients were positive about HELP-COPD, discussing their concerns and coping strategies in all domains, but the questionnaires were burdensome for some patients. Adaptation to their slowly progressive disability and a strong preference to rely on family support was reflected in limited acceptance of formal services. Professionals perceived HELP-COPD as addressing an important aspect of care, although timing overlapped with discharge planning.ConclusionsThe HELP-COPD intervention was well received by patients and the concept resonated with professionals, although delivery post discharge overlapped with existing services. Integration of brief holistic care assessments in the routine primary care management of COPD may be more appropriate.
| S-EPMC4532154 | biostudies-literature
Project description:BackgroundEvidence-based rehabilitative interventions, if widely implemented, could equip people with dementia and their families to manage life with the condition and reduce the need for health and care services. The aim of this translational study, building on evidence from the GREAT randomised controlled trial, was to develop a foundation for implementing the GREAT Cognitive Rehabilitation intervention in community-based services for people with mild-to-moderate dementia.MethodsKey elements of the implementation strategy were identifying and supporting managerial and clinical leadership, conducting collaborative planning and target-setting, training and supporting practitioners, and providing external facilitation. We developed implementation plans with, and trained staff in, 14 organisations. We subsequently worked closely with 11 of these, 10 National Health Service organisations and one private home care provider, to support practitioners to deliver GREAT Cognitive Rehabilitation over a 12-month period. Outcome evaluation examined the perspectives of local steering group members, practitioners and service users, and the reach, effectiveness and cost of the intervention.ResultsImplementation was disrupted by the COVID-19 pandemic, but six organisations completed at least six months of intervention delivery. Forty-one practitioners, mainly occupational therapists, provided the intervention, and 54 people with dementia completed a course of GREAT Cognitive Rehabilitation. Goal attainment by people with dementia exceeded levels of improvement seen in the original trial. People with dementia, carers, practitioners and steering group members all evaluated the intervention positively, and economic analysis indicated that the intervention could be provided at modest cost. However, we identified a range of mainly organisational barriers that impeded implementation and limited the potential for sustainability.ConclusionsGREAT Cognitive Rehabilitation benefits people with dementia, can be delivered effectively at modest cost in routine services, and is viewed positively by people with dementia, family carers and practitioners. To fully realise these benefits and achieve widespread and sustainable implementation, however, requires sufficient resources and a reorientation of service priorities towards preventive and rehabilitative approaches.Trial registrationNational Institute for Health Research (NIHR) Central Portfolio Management System, registration number 38994.
| S-EPMC9925212 | biostudies-literature
Project description:Prognostic stratification of elderly patients with chronic obstructive pulmonary disease (COPD) is difficult due to the wide inter-individual variability in the course of the disease. No marker can exactly stratify the evolution and natural history of COPD patients. Studies have shown that leukocyte count is associated with increased risk of mortality in COPD patients. The aim of this study was to evaluate the possible role of relative lymphocyte count as a risk marker for mortality in elderly patients with COPD.This is a3-year prospective study. A total of 218patients, mean age 75.2±7 years, with moderate to severe COPD and free from conditions affecting lymphocyte count were enrolled. The population was divided into two groups according to the relative lymphocyte count, with a cut-off of 20%. Eighty-five patients (39%) had a relative lymphocyte count ?20%. Three-year mortality rates from any cause in patients with relative lymphocyte count ? or?>?20% were 68 and 51%, respectively (p?= 0.0012). Survival curve analysis showed higher mortality in patients with relative lymphocyte count ?20% (p?= 0.0005). After adjustment for age and sex, the hazard ratio for mortality risk according to lymphocyte count was 1.79 (95% confidence interval [CI]: 1.26-2.57, p?= 0.0013), even in the analysis limited to the 171 patients without congestive heart failure (1.63; 95% CI: 1.03-2.58, p?=?0.038).Low relative lymphocyte count was associated with higher mortality in elderly patients with severe COPD.
| S-EPMC6045885 | biostudies-other