The Clear Conversations Project

NCT06508840 | Recruiting

• 2 other identifiers: 185136336469
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

Understanding health information can be difficult. This means some people struggle to know how to manage their health. Also, people may not know what health services to use or when to use them. This can lead to poorer health. It is therefore important health workers can communicate information clearly. This is so people using health services can understand it and know what to do. Having clear conversations with service users could help them to improve their health. More research is needed into this area. This is so we can understand and improve health conversations. In this research project health workers will be provided with training. The training will teach them ways to improve their communication skills. Health workers will also receive support from a Health Literacy Officer. The Investigators want to see if this can improve service user outcomes and reduce health inequalities. The investigators will ask health workers and service users from a Local Authority and an NHS service to take part. Service users will attend the health programmes as normal. Staff who have and have not received the training will deliver the programmes. The investigators will ask service users to complete questionnaires. The investigators will also collect service user data from the programmes. This data will be collected before and after they attend. The investigators will compare this data with the previous year. The investigators will observe health workers delivering the programmes. The investigators will use a check list to see how they use the skills they have learnt. The investigators will ask health workers to complete a questionnaire before and after they attend the training. The investigators will run focus groups with the health workers six months later. The investigators want to understand if the training was useful. The investigators also want to know if the health workers are using the skills they learnt in their practice.

Conditions

COPD; Weight Loss

Outcome Measures

Primary Outcomes (2)

• The Chronic Respiratory Disease Questionnaire (CDRQ)

  The CRQ is an interviewer-administered questionnaire measuring both physical and emotional aspects of chronic respiratory disease. The total score for the CRDQ ranges from 0 to 100, with higher scores indicating better HRQOL

  0, 6 weeks

• Weight in kilogrammes

  Services attending the weight management programme will be weighed at the start and end of the programme

  0, 12, 26 weeks

Secondary Outcomes (5)

• The short Warwick and Edinburgh Mental Health and Well being Scale (weight management programme only)

  0 and 12 weeks

• Incremental shuttle walking test in meters (Pulmonary Rehab prgramme only)

  0, 6 weeks

• Lung Information Needs Questionnaire (LINQ) - pulmonary rehab programme

  0, 6 weeks

• Generalised Anxiety Disorder Assessment (GAD-7) - Pulmonary rehab programme

  0, 6 weeks

• Patient Health Questionnaire (PHQ-9) - Pumonary rehab programme

  0-6weeks

Study Arms (2)

Pulmonary Rehab Programme

Pulmonary Rehab Programme staff and patients. The five physiotherapists who deliver the programmes will receive Verbal Health Literacy training and implementation support. Patients will enrol and complete the Pulmonary Rehab programme as usual. That is two sessions a week for six weeks.

Other: Verbal Health Literacy training session

Weight Management Programme

Six out of twelve Health Improvement Advisors, who deliver the programmes, will receive Verbal Health Literacy Training and implementation support. Service users will attend the programme as usual. That is one session a week for 12 weeks.

Other: Verbal Health Literacy training session

Interventions

Verbal Health Literacy training session OTHER

Five respiratory physiotherapists and half (6/12) weight management programme advisors, will receive a two hour Verbal Health Literacy training session. The training session will focus on three techniques: simple language, 'Teachback' and 'Chunk and check'. They will also receive implementation support from a Health Literacy Officer. All pulmonary rehab patients will attend programmes run by physiotherapists trained in Verbal Health Literacy techniques. Weight management programme service users will attend programmes run by trained and untrained staff.

Pulmonary Rehab Programme; Weight Management Programme

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Physiotherapists and Health Improvement Advisors working in the pulmonary rehab programme and weight management programme respectively. Patients/services users attending either of the two programmes during the study period.

You may qualify if:

• Public Health Intervention Advisors delivering the tier 2 weight management programme across Derbyshire.
• Physiotherapists and specialist nurses involved in the assessment of patients and delivery of the six week DCHS NHS pulmonary rehabilitation programme.
• Adults aged 18 or over who start the rolling 12 week tier two weight management programme during the intervention period.
• Adults aged 18 or over, with Chronic Obstructive Pulmonary Disease, who are being assessed for and undertaking the six week pulmonary rehabilitation programme during the study intervention period.
• For the staff questionnaire only - Healthcare staff from other services that attend Verbal Health Literacy training, during the study period in 2024, will also be eligible

You may not qualify if:

• Service users attending the two service programmes outside of the data collection period.
• Other pulmonary rehabilitation staff. i.e. staff who are not physiotherapists or specialist nurses.

Sponsors & Collaborators

• University of Sheffield: lead
• Derbyshire Community Health Services NHS Foundation Trust: collaborator
• Debyshire County Council: collaborator

Study Sites (2)

Derbyshire County Council

Matlock, Chesterfield, DE43AG, United Kingdom

RECRUITING

Derbyshire Community Health Services NHSFT

Chesterfield, Derbyshire, S42 7JE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Weight Loss

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms

Study Officials

• Cheryl Grindell, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Grindell, PhD

CONTACT

44 7934178779; c.a.grindell@sheffield.ac.uk

Alicia O'Cathain, PhD

CONTACT

44 114 2220770; a.ocathain@sheffield.ac.uk

Study Design

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

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-07

Locations

GB (2)