None listed
Conditions
Brief summary
Obstructive Airway Diseases (OAD) such as asthma and Chronic Obstructive Pulmonary Disease (COPD) are common among older people and cause a significant and increasing disease burden. Management of these conditions in older people is complex. The need for new approaches to managing asthma and COPD in older people is widely recognised by the clinical and scientific community. We have suggested a multidimensional approach. The aim of this trial was to test a novel model of management in older people with asthma and COPD using multidimensional assessment and individualised management. We hypothesized that in older patients with asthma and COPD, a model of MDAIM would result in a clinically important improvement in health related QOL compared to usual care.
Interventions
The intervention consists of individualised management based on the baseline multidimensional assessment. A personalised care plan is developed by the study physician and study co-ordinator. The clinicians and participants agree on the tailored interventions for each of the identified problems. An inflammometry algorithm is used to inform treatment decisions for airway and systemic inflammation and mucus hypersecretion. Other tailored interventions are standardised according to best available evidence . A case manager coordinates the plan. The interventions are delivered over the first 3 months during several individualised visits. Participation in pulmonary rehabilitation occurs concurrently. The tailored interventions are standardised according to best available evidence and will include: optimal medical management including tailoring pharmacotherapy according to airway and systemic inflammation and guiding the exacerbation plan, individualised smoking cessation counseling and pharmacotherapy, management of anxiety and depression, management of mucous hypersecretion, exacerbation management, management of dysfunctional breathing, correction of nutritional and metabolic disorders, implementation of domiciliary oxygen, self management education and support, management of airflow obstruction and co-morbidities, correction of adherence, exercise training, treatment of infection, management of dyspnea, symptoms and patient identified problems. Pharmacotherapy tailored to airway inflammation (AI) Macrolide Antibiotics for the treatment of neutrophilic bronchitis. Participants with a sputum neutrophil count greater than 61% and a productive cough are treated with oral Azithromycin 250mg three times weekly. Corticosteroid therapy for eosinophilic bronchitis The treatment algorithm published by Siva is used to guide any changes to the maintenance ICS dose. Allergic Aspergillosis Assessment: total IgE, aspergillus specific IgE Intervention: Participants with with a clinical diagnosis of Allergic Bronchopulmonary Aspergillosis are treated with (oral)Itraconazole 200mg daily for 16 weeks Systemic Inflammation: Serum CRP is measured. Systemic inflammation is defined as CRP>3mg/l. In the absence of any contraindications these participants are treated with oral simvastatin 20mg nocte. Individualised Self Management education Intervention: Information about the pathophysiological changes related to their airways disease, guidance in appropriate symptom recognition and assisted with behavioral change strategies to improve outcomes. In addition to this participants are given an individualized written self management plan with instruction for the management of exacerbations, have their inhaler device skills assessed, reviewed and corrected and adherence assessed and corrected. Tailored Pulmonary Rehabilitation Participants attend a Pulmonary Rehabiltation programme involving an 8 week exercise and education programme. Breathing Strategies Intervention: A range of different breathing techniques are taught including pursed lip breathing, active expiration, diaphragmatic breathing, adapting specific body positions, and coordinating paced breathing with activities. Muco-ciliary clearance Assessment: We screen for the presence of mucus hypersecretion by patient report using a validated assessment of mucus hypersecretion. A volume of greater than 25mls of mucus produced per day is used to define mucus hypersecretion as a problem. Intervention: Review by a physiotherapist for assessment and instruction in the use of devices (PEP, Accapella, Pari pep or Flutter) to assist with muco-ciliary clearance (MCC). In those with excessive secretions, nebulised hypertonic saline 6% 10mls is used. Cardiac Failure Assessment: BNP is measured in all patients. Intervention: Participants will be managed according to Australian heart failure guidelines. Anxiety management Assessment: The Hospital Anxiety and Depression Scale (HADS) A score of > 8 in either domain indicates possible anxiety or depression. Intervention: Patient are taught how to recognise symptoms of stress and panic and how to implement stress management strategies. Relaxation methods are taught and supplementary audiovisual material provided for use at home. Management of nutritional and metabolic disorders 3 pronged intervention tailored to BMI. All receive an individualised dietetic intervention, delivered by a dietitian. Advice: the components of a balanced diet, promoting anti-inflammatory foods high in Omega 3 fatty acids, antioxidants and calcium for bone health. Underweight –Healthy intervention plus nutritional supplements and counselling. Dietetic information regarding weight gain, including a high protein (1.2-1.5g Protein per Kg Ideal Body Weight), high energy (120% of Estimated Energy Requirements) eating plan and a nutritionally complete oral supplement (Two Cal HN, Abbott Nutrition and/or Sustagen Hospital Formula, Novartis Nutrition). Overweight – Healthy intervention plus dietetic intervention that focused on weight reduction/weight maintenance through a non very low calorie diet. ‘Lose it Fast’ Osteoporosis: Dual-energy x-ray absorptiometry (DXA) is performed. Pharmacotherapy based on the Australian Osteoporosis guidelines Smoking: Counselling plus Nicotine Replacement therapy (topical) or oral Varenicline The overall duration of this study is 2 years.
Sponsors
Study design
Eligibility
Inclusion criteria
>55 years pre bronchodilar FEV1 <80%, FER <0.7 Doctor diagnosed COPD or Asthma Disease stability in the previous 4 weeks Participants are postponed if they have required antibiotics or oral corticosteroids for an acute exacerbation of their airways disease within the previous month, or if they are experiencing a current acute illness.
Exclusion criteria
Participants are excluded if they have a malignancy, or a significant co-morbidity that the study visits and interventions may impact on or have a poor prognosis with an anticipated life expectancy of <3 months. Participants must be able to attend the visits and have satisfactory written and verbal English language skills