A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF
研究概览
简要总结
Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach
详细描述
The intervention will be developed and its effectiveness and feasibility tested via 3 stages: Stage1: Relevant background research will be performed to inform intervention design; stage 2: the intervention will be co-designed with relevant stakeholders and stage 3: the developed intervention will be trialled in a multicentre setting and feedback obtained from stakeholders to refine the intervention. A mixture of qualitative and quantitative methods will be used in this project.
The trial hypothesises that the holistic, person-centred frailty-attuned intervention will benefit CHF patients not only in terms of improved physical function but also QoL and reduce hospitalisations. This might also reduce NHS costs associated with managing adverse outcomes of at-risk patients. On the wider level, the intervention could potentially improve the care and outcomes in patients with CHF nationally and internationally.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 65 years or above.
- •Diagnosed with CHF for at least 1 year (Signs and symptoms of HF & either LVEF <40% or LVEF ≥40% with evidence of structural cardiac abnormality on echocardiogram including increased left atrial size, LV hypertrophy or impaired LV filling and/or raised natriuretic peptides: B-type natriuretic peptide (BNP) <35 pg/mL/ N-terminal pro-B-type natriuretic peptide (NT-proBNP) <125 pg/mL)
- •Willing to actively engage in a 12-week intervention developed by our team targeting older people with frailty and CHF
- •Willing to wear a wrist accelerometer for 7 days before the intervention as well as during the 12-week intervention to assess physical activity profile and monitor adherence to exercise programme
- •Willing to comply with all study requirements.
- •Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
- •Willing to provide feedback regarding the intervention in the form of interview/ focus groups/ surveys to help refine the intervention
- •Willing for audio recordings or note taking to take place during interviews/ focus groups
排除标准
- •• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study.
- •Significant cognitive impairment that affects the participant's ability to adhere to intervention.
- •Recent wrist fracture or operation that affects the participant's ability to wear a wrist accelerometer
- •Recent injury or operations that would significantly reduce the participants ability to engage in their normal daily activities
- •Participants who are currently recruited into another research study involving a lifestyle intervention
- •Participants who are undergoing major operations during the 12-week intervention
- •Participants unable to give informed consent
结局指标
主要结局
Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF
时间窗: Up to 6 months
Obtained by focus groups and interviews with patients, carers and healthcare professionals.
Phase I: Qualitative evaluation with stakeholders to identify gaps in current HF care pathway leading to unmet healthcare needs in older people living with frailty and CHF
时间窗: Up to 6 months
Obtained by focus groups and interviews with patients, carers and healthcare professionals.
Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration
时间窗: Up to 6 months
Measured with accelerometer data.
Phase III: Change in physical function as assessed by the SPPB upon completion of 12-week intervention and at 6 month follow up (this may alter depending on findings from Phase II)
时间窗: Up to 6 months
Measured with Short Physical Performance Battery (SPPB) instrument.
次要结局
未报告次要终点