跳至主要内容
临床试验/NCT06260995
NCT06260995已完成不适用

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

University of Dublin, Trinity College1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Self-Efficacy for Exercise Scale

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Social Prescribing

Participants are those who are referred or self-referred to a social prescribing link worker for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities.

干预措施: Social Prescribing Link Worker Intermediary Intervention (Other)

Local Sports Partnership

Participants are those who are referred or self-referred to a local sports partnership community development officer for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities.

干预措施: Local Sports Partnership Community Development Officer Intervention (Other)

结局指标

主要结局

Self-Efficacy for Exercise Scale

时间窗: At baseline (T0) and at the 12-week follow-up assessment (T1)

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.

International Physical Activity Questionnaire - Short Form

时间窗: At baseline (T0) and at the 12-week follow-up assessment (T1)

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.

Short Warwick Edinburgh Mental Well-being Scale

时间窗: At baseline (T0) and at the 12-week follow-up assessment (T1)

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.

次要结局

  • Demographics and Health Status(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))
  • Semi-structured Interviews - Intervention Participants(At the 12-week follow-up assessment (T1))
  • Gatekeeper Recruitment Logs(Ongoing throughout the recruitment period)
  • Semi-structured Interviews - Gatekeepers(At the end of the recruitment period, when recruitment logs have been returned)
  • Overall Acceptability of the Intervention(At the 12-week follow-up assessment (T1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Megan O'Grady

Principal Investigator

University of Dublin, Trinity College

研究点 (1)

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