Management of Depression and Anxiety in HF

NCT ID: NCT04636944

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-02

Study Completion Date

2022-04-01

Brief Summary

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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 depressionÍž 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.

Detailed Description

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Conditions

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Heart Failure Depression Anxiety

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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web-based COMPASS intervention

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Patients with NYHA class I-III;
3. Capacity to provide informed consent; and
4. Proficiency in English language so can fully respond to verbal and written material.


1. 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;
2. Capacity to provide informed consent;
3. Community HF-nurses who are actively providing care to community-based HF patients; and
4. have access to internet connected computer or device and technology for Microsoft (MS) Teams.

Exclusion Criteria

1. Community-based HF patients under 18 years of age;
2. Participants who are deemed not to have the capacity to consent;
3. Patients with cognitive impairment or dementia confirmed by medical records; and
4. Community-based HF patients with NYHA class IV.
5. Patients with severe depression and/or having suicidal ideation.


1. Nurses working with inpatients or in the OPD departments; and
2. Nurses who are not employed as community HF nurses.
3. Any community HF nurse who do not have access to internet or online technology.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silapiya Smith

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Catherine Evans

Role: STUDY_DIRECTOR

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

Locations

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Community Heart Failure Team: Elmcourt Health Centre

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IRAS ID: 268951

Identifier Type: -

Identifier Source: org_study_id

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