Clinical trial NCT06386640: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
Official title: A Holistic Patient-centred Intervention to Improve Outcomes of Older People Living With Frailty and Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Frailty
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults with frailty and chronic heart failure

Brief summary: Two-centre complex intervention development and feasibility trial using mixed qualitative and quantitative approach

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • 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)
  * CFS ≥5
  * 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

Exclusion Criteria:

* • 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

Primary outcomes:
measure: 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
timeFrame: Up to 6 months
measure: Phase II: Co-design and production of a holistic, patient-centered intervention addressing various healthcare needs of older people living with frailty and CHF
timeFrame: Up to 6 months
measure: Phase IIa: Time spent in sedentary, light, moderate and vigorous activity over monitoring duration
timeFrame: Up to 6 months
measure: 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)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
Study officials:
References: