BMC geriatrics
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Randomized Controlled Trial
Effectiveness of a muticomponent workout program integrated in an evidence based multimodal program in hyperfrail elderly patients: POWERAGING randomized clinical trial protocol.
Short-term and mid-term comparison of the efficacy of a multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education, in comparison to the standard medical practice in the improvement of the neuromuscular and physiological condition. Furthermore, it is intended to analyse the maintenance of these effects in a long-term follow-up (12 months) from the onset of the intervention. ⋯ A multimodal program that incorporates a therapeutic workout program, medication review, diet adjustment and health education may be effective treatment to reduce the functional decline in elderly. The results of the study will provide information on the possible strengths and benefits in multimodal program in elderly.
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Randomized Controlled Trial
The cost-effectiveness of a telephone-based intervention to support caregivers of older people discharged from hospital.
A telephone intervention for caregivers of older people discharged from hospital was shown to improve preparedness to care, reduce caregiver strain and caregiver distress. No cost-effectiveness analysis has been published on this, or similar interventions. The study aims addressed here were to examine whether positive outcomes for caregivers resulting from the Further Enabling Care at Home (FECH) program changed the use and costs of health services by patients; and to assess cost-effectiveness. ⋯ To our knowledge this is the first work to calculate the cost-effectiveness of a telephone-delivered intervention designed to support caregivers of older people post-discharge, and will support decision-making regarding implementation. Further research should examine different settings, and assess impacts on health service use with larger samples and a longer follow-up.
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Randomized Controlled Trial Pragmatic Clinical Trial
The effect of SENATOR (Software ENgine for the Assessment and optimisation of drug and non-drug Therapy in Older peRsons) on incident adverse drug reactions (ADRs) in an older hospital cohort - Trial Protocol.
The aim of this trial is to evaluate the effect of SENATOR software on incident, adverse drug reactions (ADRs) in older, multimorbid, hospitalized patients. The SENATOR software produces a report designed to optimize older patients' current prescriptions by applying the published STOPP and START criteria, highlighting drug-drug and drug-disease interactions and providing non-pharmacological recommendations aimed at reducing the risk of incident delirium. ⋯ We will conduct a multinational, pragmatic, parallel arm Prospective Randomized Open-label, Blinded Endpoint (PROBE) controlled trial. Patients with acute illnesses are screened for recruitment within 48 h of arrival to hospital and enrolled if they meet the relevant entry criteria. Participants' medical history, current prescriptions, select laboratory tests, electrocardiogram, cognitive status and functional status are collected and entered into a dedicated trial database. Patients are individually randomized with equal allocation ratio. Randomization is stratified by site and medical versus surgical admission, and uses random block sizes. Patients randomized to either arm receive standard routine pharmaceutical clinical care as it exists in each site. Additionally, in the intervention arm an individualized SENATOR-generated medication advice report based on the participant's clinical and medication data is placed in their medical record and a senior medical staff member is requested to review it and adopt any of its recommendations that they judge appropriate. The trial's primary outcome is the proportion of patients experiencing at least one adjudicated probable or certain, non-trivial ADR, during the index hospitalization, assessed at 14 days post-randomization or at index hospital discharge if it occurs earlier. Potential ADRs are identified retrospectively by the site researchers who complete a Potential Endpoint Form (one per type of event) that is adjudicated by a blinded, expert committee. All occurrences of 12 pre-specified events, which represent the majority of ADRs, are reported to the committee along with other suspected ADRs. Participants are followed up 12 (+/- 4) weeks post-index hospital discharge to assess medication quality and healthcare utilization. This is the first clinical trial to examine the effectiveness of a software intervention on incident ADRs and associated healthcare costs during hospitalization in older people with multi-morbidity and polypharmacy.
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Randomized Controlled Trial Multicenter Study
'We DECide optimized' - training nursing home staff in shared decision-making skills for advance care planning conversations in dementia care: protocol of a pretest-posttest cluster randomized trial.
Due to the gradual loss of function, it is crucial for persons with dementia to discuss advance care planning in due course. However, nursing home staff, residents and their families feel uncomfortable to start this type of conversation, resulting in unknown (care) preferences. 'We DECide optimized' will provide tools to nursing home staff for discussing advance care planning. The primary objective is to enhance the level of shared decision-making in advance care planning conversations. We hypothesize that the training will enhance the perception of the importance, competence and frequency in which participants engage in advance care planning conversations. The secondary objective is to assess barriers and facilitators in the implementation of advance care planning policies at the ward level. ⋯ This study describes a hands-on, in-depth and multi-level training approach to improve shared decision-making in advance care planning conversations. By providing tools to ward staff, engaging the management and informing residents and their families, 'We DECide optimized' aims to decrease evidence-based barriers and to provide all stakeholders with incentives to engage in conversations about (care) preferences in an informative and participatory manner.
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Randomized Controlled Trial Multicenter Study
Effectiveness of an intervention in multicomponent exercise in primary care to improve frailty parameters in patients over 70 years of age (MEFAP-project), a randomised clinical trial: rationale and study design.
Physical activity may reverse frailty in the elderly, but we encounter barriers to the implementation of exercise programs in this population. Our main aim is to evaluate the effect of a multicomponent physical activity program, versus regular medical practice, on reverting pre-frailty status among the elderly, 12 months post-intervention. ⋯ Within the context of regular clinical practice, our results will provide evidence regarding the effects of exercise interventions on frailty among pre-frail older adults, a key population given their significant potential for functional, physical, and mental health improvement.