Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573242
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Home-based Cardiac Rehabilitation for People Living With Heart Failure and Their Caregivers- The DKREACH-HF Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Home-based Cardiac Rehabilitation for People Living With Heart Failure and Their Caregivers- The DK REACH-HF Pilot Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Participation in cardiac rehabilitation CR is a strong recommendation of clinical guidelines for the management of heart failure HF because it is demonstrated to be a clinically effective and cost-effective intervention Despite this Danish data shows the uptake of CR is suboptimal 51 A major barrier is that the traditional mode of CR provision is centre based Travelling time and cost dislike of group exercise and inconvenient timings are some key problems to participation A potential solution is use of home-based programmes as an alternative to traditional CR
A novel home-based programme for patients with HF and their caregivers REACH-HF developed in the United Kingdom has achieved improvements in quality of life and proven to be cost effective The REACH-HF program is translated and adapted into a Danish context DK REACH-HF and is now ready to be tested in a Danish setting
The aim of this project is to improve the access and uptake of CR among HF patients in Denmark particularly in subgroups of patients who currently do not benefit from center-based CR
A novel home-based programme for patients with HF and their caregivers REACH-HF developed in the United Kingdom has achieved improvements in quality of life and proven to be cost effective The REACH-HF program is translated and adapted into a Danish context DK REACH-HF and is now ready to be tested in a Danish setting
The aim of this project is to improve the access and uptake of CR among HF patients in Denmark particularly in subgroups of patients who currently do not benefit from center-based CR
Detailed Description:
Globally Heart Failure HF is a common and severe disease affecting millions of people and a major driver of poor health-related quality of life HRQoL increased risk of hospitalization and high healthcare costs Due to the aging of the population as well as the improvements of life-prolonging cardiovascular invasive and medical treatments the prevalence of patients living with HF is increasing and as many as 1 in 5 people are expected to develop HF during their lifetime Cardiac rehabilitation CR for people living with HF has been demonstrated to be clinically efficacious and cost-effective by improving HRQoL and reducing the risk of hospital readmission Guidelines therefore strongly recommend CR for people living with HF However the uptake and provision of CR for people with HF in Denmark is suboptimal with only 51 of HF patients participating Furthermore there is evidence of social inequality in both referral and participation rates Reasons for low uptake are complex but a major barrier is that traditional mode of CR provision is center based Barriers to center-based programs for patients include travel time and costs and dislike of group sessions A key potential solution is therefore greater use of alternative modes of CR delivery
Developed in the UK Rehabilitation EnAblement in CHronic Heart Failure REACH-HF is an evidence- and theory-based patient-centred self-care home-based support program co-developed with patients caregivers and clinicians to meet the above challenges Evaluated in the multicenter randomized controlled trial participation in the REACH-HF programme has shown improved HRQoL for patients with HF and to be cost-effective in a UK healthcare setting Furthermore caregivers increased their confidence in the caregiver role The REACH-HF is now being rolled out routinely across the UK National Health Service improving CR access for people with HF and their caregivers Including the core components of comprehensive CR the REACH-HF program aligns with Danish guidelines As part of the DKREACH-HF project the REACH-HF program and its materials have been translated and adapted into a Danish context This adaptation process included the consideration of contextual differences between the healthcare systems legislation and culture of UK and Denmark and was informed by interviews with leaders and experts in cardiology healthcare professionals working with HF in both hospital and municipality settings as well as caregivers and patients Following this evidence-based approach the DKREACH-HF is now ready to be assessed for its feasibility and acceptability to inform wider implementation for Danish patients with HF and their caregivers
To investigate the feasibility of the DKREACH-HF program the investigators will employ a single-arm pre-post mixed methods design with a parallel process evaluation across two-three sites in Denmark This will involve hospital centers and where applicable local municipalities where the DKREACH-HF program will be delivered as an alternative to usual care
The investigators intend to recruit a total of 75 HF patients and their caregivers where applicable who will each receive the DKREACH-HF programme delivered by a team of one or two trained intervention-facilitators
DKREACH-HF is a home-based 12-week CR program for people living with HF and their caregivers
Intervention Patients and where applicable caregivers will be provided with the DK REACH-HF manuals orand a digital mobile phone application Mobile app Mit Liv My Life translated based on their preference and consist of four core elements
The REACH-HF manual for patients that includes a detailed information on how to live with HF including topics as the understanding of what HF is managing symptom monitoring information about managing medications managing breathlessness and anxiety and a choice of two structured progressive exercise programmes a walking orand a chair-based programme
A Patient Progress Tracker an interactive booklet designed to facilitate learning from experience to record daily physical activity symptoms weight and fluid monitoring etc
The Family and Friends Resource a manual for caregivers aimed to increase their understanding of HF and focus on their own physical and mental health and wellbeing
A two-day course for facilitators who will tailor the intervention for patients and caregivers
Quantitative data
Given the pilot nature of the study the focus of statistical analysis and data presentation will take a descriptive approach for baseline demographic and outcome data Continuous data will be reported as means standard deviation or percentage Categorical data will be reported as frequencies and percentages Pre-post-differences in outcomes will be reported as means and 95 confidence intervals
Qualitative data
A semi structured interview guide will be used in the process evaluation and will focus on topics such as practical issues managing the DKREACH-HF intervention program from both a facilitator and participant perspective delivery of the intervention participant experience of the intervention etc The transcribed qualitative data will be coded using NVivo and analyzed using qualitative thematic analysis as described by Braun and Clark
Mixed methods
The investigators will use both qualitative and quantitative data to gain a more complete and deeper understanding of issues relating to homebased CR for people living with HF and their caregivers as well as for health care providers included as facilitators in the study By using a mixed methods approach to answer the aim of this research the investigators believe it can be examined in a more nuanced way
Developed in the UK Rehabilitation EnAblement in CHronic Heart Failure REACH-HF is an evidence- and theory-based patient-centred self-care home-based support program co-developed with patients caregivers and clinicians to meet the above challenges Evaluated in the multicenter randomized controlled trial participation in the REACH-HF programme has shown improved HRQoL for patients with HF and to be cost-effective in a UK healthcare setting Furthermore caregivers increased their confidence in the caregiver role The REACH-HF is now being rolled out routinely across the UK National Health Service improving CR access for people with HF and their caregivers Including the core components of comprehensive CR the REACH-HF program aligns with Danish guidelines As part of the DKREACH-HF project the REACH-HF program and its materials have been translated and adapted into a Danish context This adaptation process included the consideration of contextual differences between the healthcare systems legislation and culture of UK and Denmark and was informed by interviews with leaders and experts in cardiology healthcare professionals working with HF in both hospital and municipality settings as well as caregivers and patients Following this evidence-based approach the DKREACH-HF is now ready to be assessed for its feasibility and acceptability to inform wider implementation for Danish patients with HF and their caregivers
To investigate the feasibility of the DKREACH-HF program the investigators will employ a single-arm pre-post mixed methods design with a parallel process evaluation across two-three sites in Denmark This will involve hospital centers and where applicable local municipalities where the DKREACH-HF program will be delivered as an alternative to usual care
The investigators intend to recruit a total of 75 HF patients and their caregivers where applicable who will each receive the DKREACH-HF programme delivered by a team of one or two trained intervention-facilitators
DKREACH-HF is a home-based 12-week CR program for people living with HF and their caregivers
Intervention Patients and where applicable caregivers will be provided with the DK REACH-HF manuals orand a digital mobile phone application Mobile app Mit Liv My Life translated based on their preference and consist of four core elements
The REACH-HF manual for patients that includes a detailed information on how to live with HF including topics as the understanding of what HF is managing symptom monitoring information about managing medications managing breathlessness and anxiety and a choice of two structured progressive exercise programmes a walking orand a chair-based programme
A Patient Progress Tracker an interactive booklet designed to facilitate learning from experience to record daily physical activity symptoms weight and fluid monitoring etc
The Family and Friends Resource a manual for caregivers aimed to increase their understanding of HF and focus on their own physical and mental health and wellbeing
A two-day course for facilitators who will tailor the intervention for patients and caregivers
Quantitative data
Given the pilot nature of the study the focus of statistical analysis and data presentation will take a descriptive approach for baseline demographic and outcome data Continuous data will be reported as means standard deviation or percentage Categorical data will be reported as frequencies and percentages Pre-post-differences in outcomes will be reported as means and 95 confidence intervals
Qualitative data
A semi structured interview guide will be used in the process evaluation and will focus on topics such as practical issues managing the DKREACH-HF intervention program from both a facilitator and participant perspective delivery of the intervention participant experience of the intervention etc The transcribed qualitative data will be coded using NVivo and analyzed using qualitative thematic analysis as described by Braun and Clark
Mixed methods
The investigators will use both qualitative and quantitative data to gain a more complete and deeper understanding of issues relating to homebased CR for people living with HF and their caregivers as well as for health care providers included as facilitators in the study By using a mixed methods approach to answer the aim of this research the investigators believe it can be examined in a more nuanced way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None