The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol

Physical Inactivity Clinical Trial

Official title:

The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Protocol for a Non-randomized Pilot Feasibility Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260995
• Other study ID #: Ref: 230603
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of Dublin, Trinity College
• Contact: Megan O'Grady
• Phone: 018963613
• Email: ogradyme[@]tcd.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time.

This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future.

Description:

BACKGROUND

Physical inactivity is a major issue affecting health, and was declared a global pandemic by the World Health Organization. Effective methods of physical activity promotion are needed. An 'intermediary' is an emerging method to address the problem of physical inactivity. Intermediaries are health-related workers who support individuals to improve their health and wellbeing by facilitating connections to local physical activities. Preliminary evidence for this intervention is positive for improving physical activity levels and wellbeing, but is based on trials using less robust designs. When evaluating complex interventions, feasibility testing is recommended in order to make decisions about progression to the evaluation phase.

METHODS

This will be a non-randomized mixed methods pilot feasibility study. This overall aim of this study is to investigate the feasibility of an intervention delivered by an intermediary to improve physical activity and health-related outcomes of community-dwelling adults. Participants will be recruited through two types of intermediary services in Ireland; social prescribing and local sports partnerships. A total of 30 participants will be recruited (15 per service). This study comprises two strands. Strand 1 is a non-randomized prospective cohort study. A baseline assessment will be taken upon enrolment on to the study. Baseline demographic information will be taken and three questionnaires will be completed: the International Physical Activity Questionnaire - Short Form, Self-Efficacy for Exercise Scale and Short Warwick Edinburgh Mental Well-being Scale. The questionnaires will be repeated after 12 weeks. Strand 2 is a qualitative phase consisting of semi-structured exit interviews with intervention participants conducted at the 12-week follow-up assessment. These will be carried out to explore intervention content and delivery, as well as acceptability of the intervention and evaluation design. In addition, study gatekeepers will be asked to keep a record of how many clients they had contact with, how many people were approached about the study, and the reasons for refusal to take part in the study. Semi-structured interviews will also be conducted with gatekeepers at the end of the recruitment period to explore the acceptability of the recruitment methods.

DISCUSSION

This study will investigate the feasibility of the intervention delivered by an intermediary, and any indications of change in physical activity and health-related outcomes. It will also investigate the feasibility and acceptability of the evaluation design, specifically recruitment methods and choice of outcome measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria

• Aged =18 years

• Referred to intermediary service for any reason OR self-referred to intermediary service for any reason

• Meets the eligibility criteria of the intermediary service

• Intermediary facilitates a connection to local physical activity

Exclusion criteria

• Non-community dwelling e.g., hospital in-patients, living in residential care facilities

• Diagnosis of dementia

• Inappropriate for health or social reasons (such as terminal illness, family or other social crisis)

• Refused to engage with the intermediary service

• Unable to give explicit informed consent

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Other:
• Social Prescribing Link Worker Intermediary Intervention
Social prescribing link workers [SPLW] receive referrals from healthcare professionals, community services, or through self-referral. Individuals are referred for social isolation or social needs, frequent healthcare attendance, or to address a pre-existing health issue. SPLW carry out an in-depth assessment of the individual's needs, and then work with the individual over weeks and months to connect them to community services and supports, which can include local physical activities. They use several strategies during this follow-up period, such as instrumental support (doing things for the individual), empowerment and motivation techniques and/or attending activities with the individual. After the SPLW establishes a connection to a local physical activity, the individual enrols and participates in the chosen activity. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi.
• Local Sports Partnership Community Development Officer Intervention
Local sports partnership community development officers [LSPO] mainly receive self-referrals, or can receive referrals, to improve physical activity levels of individuals through participation in physical activity groups delivered by the partnership. LSPO do not carry out an in-depth assessment but may carry out screening before explaining/signposting to local physical activities. They use several strategies to connect the individual to local physical activities, such as attending the first session of the group, providing reassurance and practical support, and keeping the person updated and informed as to upcoming groups. After the LSPO establishes a connection to a local physical activity, the individual enrols and participated in the chosen activity. The LSPO continues to support this engagement during the follow-up period. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi amongst others.

Locations

Country	Name	City	State
Ireland	University of Dublin, Trinity College Dublin	Dublin 8

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Physical Activity Questionnaire - Short Form	The IPAQ-SF assesses physical activity behaviour over the last seven days and includes measures of frequency and duration of vigorous physical activity, moderate physical activity, walking and sedentary behaviour. Using a standardised scoring protocol, total days of activity, total activity (minutes/week), metabolic equivalent minutes per week and physical activity category (low, moderate or high levels of physical activity) can be calculated.	At baseline (T0) and at the 12-week follow-up assessment (T1)
Primary	Self-Efficacy for Exercise Scale	A self-report measure of self-efficacy for physical activity, participants are asked to rate their current confidence in their ability to exercise three times per week for 20 minutes under different scenarios. Responses are rated on a numerical rating scale of 0-10, with 0 indicating 'not confident' and 10 indicating 'very confident'. The overall score is calculated by summing the responses to each scenario, and a higher score indicates higher self-efficacy for exercise.	At baseline (T0) and at the 12-week follow-up assessment (T1)
Primary	Short Warwick Edinburgh Mental Well-being Scale	A scale whose items cover different aspects of eudemonic and hedonic well-being. Each item is answered on a 1 to 5 Likert scale, ranging from "none of the time" to "all the time". The overall score is calculated by summing the scores for each item, and a higher score indicates a higher level of well-being.	At baseline (T0) and at the 12-week follow-up assessment (T1)
Secondary	Demographics and Health Status	Participant age, gender, marital status, area in which they live (urban/rural), level of education, ethnicity, employment status, self-reported presence/absence of chronic condition, self-reported rating of health, and types of exercise currently undertaken will be collected at baseline. These data will be used to report demographic information and health-related behaviours of the study sample.	At baseline assessment (T0). Self-reported rating of health and types of exercise will also be recorded at the 12 week follow-up assessment (T1)
Secondary	Semi-structured Interviews - Intervention Participants	This interview will explore topics such as: the content and delivery of the intervention by the intermediary, the local physical activities accessed as a result of the intervention and adherence to these, the level of support provided by the intermediary and the impact of this, and acceptability of the study measures and intervention by an intermediary.	At the 12-week follow-up assessment (T1)
Secondary	Overall Acceptability of the Intervention	As part of the semi-structured interview, participants will be asked to rate the overall acceptability of the intervention on a numerical rating scale of 1-10, with 1 indicating 'completely unacceptable' and 10 indicating 'completely acceptable'. This will allow the investigators to explore what drives participants' general acceptability judgment.	At the 12-week follow-up assessment (T1)
Secondary	Gatekeeper Recruitment Logs	Gatekeepers will be asked to keep a record of how many clients they had contact with during the recruitment period, how many people were approached about the study, and the reasons for refusal to take part in the study. These will be used to measure rates of recruitment and enrollment, and the suitability of the recruitment methods.	Ongoing throughout the recruitment period
Secondary	Semi-structured Interviews - Gatekeepers	This interview will explore topics such as: how open individuals were to take part in research and reasons given as to why they did not take part, their experience of discussing the research project with potential participants, and timing of recruitment.	At the end of the recruitment period, when recruitment logs have been returned