NCT04636944

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

October 28, 2020

Last Update Submit

October 11, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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.

    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.

    This will take place before the introduction of COMPASS web-based intervention.

Interventions

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.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from Guys and St. Thomas's community-based HF services in Lambeth and Southwark Boroughs.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Heart Failure Team: Elmcourt Health Centre

London, United Kingdom

Location

MeSH Terms

Conditions

Heart FailureDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Silapiya Smith

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
  • Catherine Evans

    Cicely Saunders Institute of Palliative Care, Rehabilitation and Policy, Faculty of Nursing, Midwifery and Palliative Care, King's College London,

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 19, 2020

Study Start

October 2, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

October 14, 2022

Record last verified: 2020-10

Locations