NCT04740489

Brief Summary

What are the experiences of staff and participants in phase 3 cardiac rehabilitation during the Covid-19 pandemic, and what impacts have adapted delivery had on participants' physical activity levels, mental health and well-being? Cardiac rehabilitation (CR) is a vital service for individuals diagnosed and treated for cardiovascular disease (e.g., heart attack, angina, valve disease). The service helps to improve recovery rates through supporting patients with beneficial lifestyle changes (e.g., physical activity, healthy eating), and coping with emotional distress following a traumatic cardiac event. The environment in which CR is being delivered has changed in response to the Covid-19 pandemic, including remote working practices, and in some instances postponing of rehabilitation. Despite the public health rationale for such measures, it is essential to consider the impact of adapted services on patient's mental health and physical activity participation, and to consider staff experiences in using remote working regimes. The current study aims to recruit staff and patients from phase 3 cardiac rehabilitation across Hampshire Hospitals Foundation Trust to explore their experiences of adapted services through a mixed methods study design. Staff and patients will be interviewed over the phone to explore experiences and impacts of Covid-19 with their rich in-depth viewpoints and stories. In addition, during an 8 week period of rehabilitation, patients will be asked to report and record their physical activity levels with diaries and accelerometers (a wrist worn device measuring movement), record their resting blood pressure and heart rate, and complete questionnaires to assess changes in mental health. This study could help to understand the impact of the pandemic on cardiac patients recovery and on staff's experiences implementing programme changes to assist in preparing for the future of CR post COVID 19.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

January 29, 2021

Last Update Submit

February 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Psychosocial health and wellbeing

    Semi structured interviews

    During qualitative interviews (post week 5).

Secondary Outcomes (8)

  • Acceptability to Participants

    During qualitative interviews after the intervention has ended (post week 5).

  • Feasible to Participants

    During qualitative interviews after the intervention has ended (post week 5).

  • Physical activity

    Week 1, 4 and 8 of rehabilitation

  • Loneliness

    Week 1, 4 and 8 of rehabilitation

  • Heart rate

    Week 1, 4 and 8 of rehabilitation

  • +3 more secondary outcomes

Interventions

Phase 3 CR is a comprehensive outpatient programme, considered the core rehabilitation phase, in which participants receive structured exercise, health education, risk factor modification and psychological support. Upon discharge from clinically supervised phase 3 CR participants are generally signposted to long-term community-based exercise classes (phase 4). The current study will take place within a core phase 3 CR programme in the UK.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Service user participants are individuals treated for acute coronary syndromes (e.g., NSTEMI, STEMI), heart failure, valve disease, and ICD's. Staff participants will be recruited from members of a multidisciplinary team including; CR professionals including CR specialist nurses, physiotherapists and exercise practitioners.

You may qualify if:

  • Aged 18 years or over
  • Staff and participants participating in Phase 3 CR
  • Able to give informed consent
  • Willing and able to undertake the interview, diary, questionnaire and accelerometer processes

You may not qualify if:

  • Aged \<18 years
  • Not participating in Phase 3 CR
  • Any individuals who are unable to represent their own interests or are particularly susceptible to coercion (vulnerable individuals), and are therefore unable to give informed consent
  • If individuals have difficulties in adequately understanding written or verbal information in English, as the study doesn't have funding for a translator or interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Central Study Contacts

Samantha J Meredith, PhD

CONTACT

Chad SG Witcher, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer in Physical Activity, Exercise and Health

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 5, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

February 5, 2021

Record last verified: 2021-01