Feasibility of Personalised Health Behaviour Coaching to Support Symptoms and Activities of Daily Living in Those With Long COVID-19.

NCT05752331 | Completed

• 1 other identifier: LCACORN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot RCT aims to assess whether a simple PA behavioural modification intervention can be delivered safely and feasibly to individuals with Long COVID suffering long standing symptoms with concerns regarding their ability to perform activities of daily living. Participants will be randomised to receive an 8-week physical activity behavioural modification intervention alongside usual care or usual care alone. The primary outcome for this study is to assess the safety and feasibility of the intervention, including recruitment targets, randomisation, completion rates and acceptability to the study.

Conditions

Long COVID

Keywords

Physical activity; Fatigue; Breathlessness

Outcome Measures

Primary Outcomes (4)

• Participant recruitment

  At least 40% of eligible participants recruited to the study

  8 weeks

• Participant randomisation

  At least 80% of participants randomised following informed consent

  8 weeks

• Participant completion

  At least 80% of randomised participants completing the intervention period and post assessment visit

  8 weeks

• Participant acceptability

  Assessed through a project tailored questionnaire on completing of the study

  8 weeks

Secondary Outcomes (9)

• Objective physical activity

  8-weeks

• Exercise capacity

  8-weeks

• Muscular strength and endurance

  8-weeks

• Lung Function

  8-weeks

• Health related quality of life

  8-weeks

Study Arms (2)

Physical activity behavioural modification

EXPERIMENTAL

The 8-week PA behavioural modification intervention will focus on engaging participants in ADL and lowering sedentary time. Each participant will receive one semi-structured motivational interview at baseline to discuss favourite activities and barriers and facilitators to PA. Participants will produce an individualised action plan following the interview that will be followed throughout the intervention to allow an individualised approach to take place. Participants will then be provided with a low-cost pedometer and PA diary to self-monitor and record daily PA. The PA diary will provide examples of various activities that can be done in and around the house, with an emphasis placed on simple, effective movements to reduce sedentary time. Following this, a researcher will conduct weekly virtual meetings with the participant to discuss the past weeks PA levels and provide future individualised goals to promote ADL.

Behavioral: Physical activity behavioural modification

Usual Care

NO INTERVENTION

All participants will be notified of the government 'your Covid recovery' programme (usual care) which provides details and support on managing long term symptoms of Covid-19.

Interventions

Physical activity behavioural modification BEHAVIORAL

8-week intervention consisting motivational interview, individualised action plan and weekly consultations regarding activities of daily living and symptom management.

Physical activity behavioural modification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People who are aged 18 years or older
• Have experienced at least one long COVID symptom for 12 weeks or longer
• Additionally meet at least one of the following criteria: 1) positive SARS-CoV-2 PCR or antigen test (positive COVID-19 test) during the acute phase of illness; 2) positive SARS-CoV-2 antibody test at any time point; 3) symptoms consistent with SARS-CoV-2 (COVID-19) infection during the acute phase.

You may not qualify if:

• Individuals who have previously been admitted to an intensive care unit (ICU) due to SARS-CoV-2
• Receiving palliative or end-of-life care
• Are actively participating in another research trial focused on long COVID

Sponsors & Collaborators

• Bournemouth University: lead

Study Sites (1)

Bournemouth University

Bournemouth, Dorset, BH12 5BB, United Kingdom

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Motor Activity; Fatigue; Dyspnea

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Officials

• Matthew Armstrong

  Bournemouth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 2, 2023
• Study Start: November 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 15, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)