Heart FailureNCT04636944
Management of Depression and Anxiety in HF
An observational study of Heart Failure and Depression, run by King's College London at 1 site in United Kingdom.
Trial summary
Heart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Depression, Anxiety
- What is being tested?
- web-based COMPASS intervention
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2020to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from Guys and St. Thomas's community-based HF services in Lambeth and Southwark Boroughs.
Who may be able to join
- Community-based HF patients with clinically established HF diagnosis (confirmed HF diagnosis) in Lambeth and Southwark Boroughs who have mild to moderate symptoms of depression with/without anxiety confirmed by PHQ-9 (5-14) and GAD-7;
- Patients with NYHA class I-III;
- Capacity to provide informed consent; and
- Proficiency in English language so can fully respond to verbal and written material.
- All community-based HF-nurses employed in Lambeth and Southwark Boroughs who are registered with Nursing Midwifery Council (NMC) will be invited to participate in the study;
- Capacity to provide informed consent;
- Community HF-nurses who are actively providing care to community-based HF patients; and
- have access to internet connected computer or device and technology for Microsoft (MS) Teams.
Who cannot join
- Community-based HF patients under 18 years of age;
- Participants who are deemed not to have the capacity to consent;
- Patients with cognitive impairment or dementia confirmed by medical records; and
- Community-based HF patients with NYHA class IV.
- Patients with severe depression and/or having suicidal ideation.
- Nurses working with inpatients or in the OPD departments; and
- Nurses who are not employed as community HF nurses.
- Any community HF nurse who do not have access to internet or online technology.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Community Heart Failure Team: Elmcourt Health Centre
London
About this study
Official title: Learning From Heart Failure Nurses and Patients: Exploring Their Perspectives in the Management of Depression and Anxiety in Primary Care Settings
Heart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Many studies reported that depression is prevalent among HF patients and it is being associated with high morbidity, mortality and costs. The European Society of Cardiology guidelines stresses the importance of routine depression screening with a validated questionnaire and initiating treatment for depression for all depressed HF patients and their access to psychological treatment.
The community heart failure nurses provide the integrated heart failure service in the local area of Southwark and Lambeth in South London. The aim of the integrated heart failure team in the community is to provide the HF treatment effectively, help patients understand and manage their symptoms and support with lifestyle changes. Even though, the community HF nurses have extensive role in managing HF patients in the community, their role in assessing anxiety and depression; and providing psychological treatment needs to be further explored.
Read more
Therefore, there is a need to assess the process by which community HF nurses assess and manage anxiety and depression. This current study builds on our recent systematic review which illustrated how cognitive behaviour therapy is effective at improving depressive symptoms in HF, but more studies are needed to build on these findings. The findings from this review will be used to examine the perspectives on assessing, managing and treating depression and anxiety in HF patients.
In this current study, an online focus group with community heart failure nurses and qualitative telephone/online interviews with community-based HF patients will be undertaken to explore their views and experiences in managing depression and anxiety; and to assess whether COMPASS a web-based intervention would be useful. Also, this study will explore the impact of COVID-19 on the psychological wellbeing of community-based HF patients.
- Conditions
- Heart Failure, Depression, Anxiety
- Being tested
- web-based COMPASS intervention
- Medical subject headings
- Heart Failure, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based COMPASS interventionOther
COMPASS is a web-based intervention (online CBT program) that was developed for managing illness-related anxiety and depression in patients with long-term conditions (LTC) (https://compass-ltc.org/). COMPASS is tailored to gain an understanding of the difficulties that LTC patients experience and provide information and tools on how to manage these. This qualitative study will explore participants' perspectives on using COMPASS for managing depression and anxiety in heart failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore community heart failure nurses' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.
will explore nurses' perception regarding the assessment and management of depression and anxiety in heart failure by undertaking an online focus group with community heart failure nurses.
Measured: This will take place before the introduction of COMPASS web-based intervention.
Explore community heart failure patients' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.
will explore patients' perception regarding the assessment and management of depression and anxiety in heart failure. This will be done by undertaking online\telephone interviews with community-based heart failure patients.
Measured: This will take place before the introduction of COMPASS web-based intervention.
Explore nurses' perception of using web-based COMPASS intervention for depression and anxiety management in HF
will explore nurses' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure in an online focus group.
Measured: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.
Explore patients' perception of using web-based COMPASS intervention for depression and anxiety management in HF
will explore patients' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure. This will be done by conducting online\telephone interviews with community-based heart failure patients.
Measured: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.
Secondary outcomes (2)
Explore with community HF nurses the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes.
will discuss with community HF nurses the impact of COVID-19 on the psychological wellbeing of community-based HF patients and how it changed their access to psychological intervention. This will form part of the online focus group.
Measured: This will take place before the introduction of COMPASS web-based intervention.
Explore with community HF patients the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes.
will explore with community HF patients the impact of COVID-19 on the psychological wellbeing of community-based HF patients and how it changed their access to psychological intervention. This will form part of the online/telephone interviews.
Measured: This will take place before the introduction of COMPASS web-based intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start2 Oct 2020
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silapiya Smith, Principal investigator, Guy's and St Thomas' NHS Foundation TrustCatherine Evans, Study director, Cicely Saunders Institute of Palliative Care, Rehabilitation and Policy, Faculty of Nursing, Midwifery and Palliative Care, King's College London,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636944
- Sponsor's protocol ID
- IRAS ID: 268951
- Status last verified
- Oct 2020
- First submitted
- 28 Oct 2020
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning From Heart Failure Nurses and Patients: Exploring Their Perspectives in the Management of Depression and Anxiety in Primary Care Settings
- ClinicalTrials.gov ID
- NCT04636944
- Acronym / sponsor ID
- IRAS ID: 268951
- Conditions
- Heart Failure, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) is a complex clinical syndrome characterized by inability of the heart to pump an adequate amount of blood. Heart failure affects patients' ability to carry out even simple activities of daily living and therefore has negative psychological impact. Many studies reported that depression is prevalent among HF patients and it is being associated with high morbidity, mortality and costs. The European Society of Cardiology guidelines stresses the importance of routine depression screening with a validated questionnaire and initiating treatment for depression for all depressed HF patients and their access to psychological treatment.
The community heart failure nurses provide the integrated heart failure service in the local area of Southwark and Lambeth in South London. The aim of the integrated heart failure team in the community is to provide the HF treatment effectively, help patients understand and manage their symptoms and support with lifestyle changes. Even though, the community HF nurses have extensive role in managing HF patients in the community, their role in assessing anxiety and depression; and providing psychological treatment needs to be further explored.
Therefore, there is a need to assess the process by which community HF nurses assess and manage anxiety and depression. This current study builds on our recent systematic review which illustrated how cognitive behaviour therapy is effective at improving depressive symptoms in HF, but more studies are needed to build on these findings. The findings from this review will be used to examine the perspectives on assessing, managing and treating depression and anxiety in HF patients.
In this current study, an online focus group with community heart failure nurses and qualitative telephone/online interviews with community-based HF patients will be undertaken to explore their views and experiences in managing depression and anxiety; and to assess whether COMPASS a web-based intervention would be useful. Also, this study will explore the impact of COVID-19 on the psychological wellbeing of community-based HF patients.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from Guys and St. Thomas's community-based HF services in Lambeth and Southwark Boroughs.
Key inclusion criteria (8 listed)
- All community-based HF-nurses employed in Lambeth and Southwark Boroughs who are registered with Nursing Midwifery Council (NMC) will be invited to participate in the study;
- Capacity to provide informed consent;
- Community HF-nurses who are actively providing care to community-based HF patients; and
- have access to internet connected computer or device and technology for Microsoft (MS) Teams.
Key exclusion criteria (8 listed)
- Nurses working with inpatients or in the OPD departments; and
- Nurses who are not employed as community HF nurses.
- Any community HF nurse who do not have access to internet or online technology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based COMPASS interventionCOMPASS is a web-based intervention (online CBT program) that was developed for managing illness-related anxiety and depression in patients with long-term conditions (LTC) (https://compass-ltc.org/). COMPASS is tailored to gain an understanding of the difficulties that LTC patients experience and provide information and tools on how to manage these. This qualitative study will explore participants' perspectives on using COMPASS for managing depression and anxiety in heart failure. | Other | – |
Primary outcome
Explore community heart failure nurses' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.
Time frame: This will take place before the introduction of COMPASS web-based intervention.
will explore nurses' perception regarding the assessment and management of depression and anxiety in heart failure by undertaking an online focus group with community heart failure nurses.
Explore community heart failure patients' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions.
Time frame: This will take place before the introduction of COMPASS web-based intervention.
will explore patients' perception regarding the assessment and management of depression and anxiety in heart failure. This will be done by undertaking online\telephone interviews with community-based heart failure patients.
Explore nurses' perception of using web-based COMPASS intervention for depression and anxiety management in HF
Time frame: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.
will explore nurses' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure in an online focus group.
Explore patients' perception of using web-based COMPASS intervention for depression and anxiety management in HF
Time frame: This will take place 30 minutes after the introduction and demonstration of COMPASS web-based intervention.
will explore patients' perception regarding the use of web-based COMPASS intervention for the management of depression and anxiety in heart failure. This will be done by conducting online\telephone interviews with community-based heart failure patients.
2 secondary outcomes
Explore with community HF nurses the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes.
Time frame: This will take place before the introduction of COMPASS web-based intervention.
Explore with community HF patients the impact of COVID-19 pandemic on HF patients' depression and anxiety level and changes to management processes.
Time frame: This will take place before the introduction of COMPASS web-based intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silapiya Smith principal investigator
Guy's and St Thomas' NHS Foundation Trust
Catherine Evans study director
Cicely Saunders Institute of Palliative Care, Rehabilitation and Policy, Faculty of Nursing, Midwifery and Palliative Care, King's College London,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Depression, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore community heart failure nurses' perception of assessing, managing and treating depression and anxiety in HF and the use of web-based interventions. (time frame: This will take place before the introduction of COMPASS web-based intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.