'Walk and Talk - Connecting People With Psoriasis'. A Mixed-methods Exploratory Study to Determine Representativeness of Recruitment, Acceptability, and Feasibility of a Walk and Talk Intervention for People With Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Participant satisfaction of a of a Walk and Talk intervention for people living with psoriasis.
研究概览
简要总结
The main aim of this study is to determine the acceptability, representativeness (e.g. age, sex, ethnicity and body mass index) and ideal format of a Walk and Talk intervention for people with psoriasis.
Secondary aims are determining outcome measures of the intervention (patient related outcome measures, social connectedness, physical activity, cardiovascular risk)
Other objectives are to determine relevant outcome measures and sample size needed to statistically evaluate a future, larger study. There have been no similar studies evaluating social interventions in people with psoriasis, so an exploratory study is needed to calculate how many people are needed to participate. Measures will include social connectedness (loneliness), physical activity, cardiovascular risk, psychological wellbeing, quality of life and psoriasis severity.
Psoriasis is a systemic disease with multiple co-existent health issues. People with psoriasis are more socially isolated and inactive than the general population.
The health implications of social isolation are now recognised and thought to be equivalent to smoking. Consequently social prescribing is increasingly used for people living with long-term conditions. Specifically group walking activities are effective at increasing physical activity and improving mood. Additionally, disease specific walking groups provide peer psychosocial support.
It seems likely that a group walking intervention for people with psoriasis could promote social connectedness, increase physical activity and provide peer psychosocial support. However, as people with psoriasis avoid social contact, have low levels of physical activity and difficulty in discussing feelings, it is possible a Walk and Talk activity may not be taken up by many, or only by specific sub-groups such as young, slim, white people. Hence the need for an exploratory study before committing to a larger adequately powered study. Ultimately the investigators anticipate a format for Walk and Talk groups that is specifically tailored for people with psoriasis may enable groups to be rolled out at centres nationwide
详细描述
STUDY DESIGN 1. 'Walk and Talk - connecting people with psoriasis' is a mixed-methods exploratory study to determine the representativeness of recruitment, acceptability, and feasibility of a walk and talk intervention for people with psoriasis.
STUDY GROUP 2. Adult patients with a diagnosis of psoriasis +/- psoriatic arthritis attending the Dermatology Department at the Royal Free NHS Trust, London will be recruited for study. Participants must be able to walk for 1 hour at a slow pace (Can participants walk around 2km in an hour), or be a wheelchair user with someone who can push up hills if necessary (the study will not provide carers for wheelchair users, if a wheelchair user wishes to participate they must bring someone who is able to help them).
METHODS
- RECRUITMENT In order to reduce bias and maximise inclusion, an 'opt-out' study design has been chosen. All patients who have attended the Royal Free London NHS Foundation Trust Psoriasis service within the last 2 years will be sent information about the study.
- If a patient does not wish to participate, they will be able to opt-out of the study and will not be contacted again.
- All patients who have not opted out will be invited to meet with an investigator to discuss entry into the study
- If after 3 attempts to contact a patient regarding the study, no response is obtained, they will not be contacted again.
- All individuals, who have not opted out, will be offered an appointment with a member of the research team. At this appointment there will be an opportunity for further discussion and questions about the study. The investigator will go through the information sheet with the potential participant.
- Eligible and willing patients will be consented to participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years or over
- •Diagnosed with psoriasis
- •Currently attending psoriasis services in secondary care
- •Must be able to walk for 30 minutes at a slow pace (approx 2km). Or be a wheelchair user with a carer who can push up hills if necessary
排除标准
- •Participants who are not capable of understanding the information leaflet or consent form and thus are unable to give informed consent.
- •Participants who do not understand verbal explanations or written information given in English will be excluded, as a number of questionnaires need to be completed. The translation service provided to the hospital is usually telephone operated.
- •Participants not able to walk at a slow pace for 30 minutes will be excluded or wheelchair users who do not have a carer who can help to push up hills.
- •Children will be excluded from study as this study involves making social interactions and contact with adults. This would not be appropriate, as child protection screens will not be performed on participants
结局指标
主要结局
Participant satisfaction of a of a Walk and Talk intervention for people living with psoriasis.
时间窗: 3 months
Found by looking at feedback and comments of participants in thematic analysis of semi-structured interview.
次要结局
- General Practice Physical Activity Questionnaire(3 months)
- Psoriasis Area and Severity Index(3 months)
- Dermatology Life Quality Index (DLQI) questionnaire(3 months)
- Medication Adherence Questionnaire (MAQ)(3 months)
- To understand the participants' experience of a weekly 'walk and talk' activity(3 months)
- Body mass index(3 months)
- Abdominal circumference(3 months)
- Blood pressure(3 months)
- Resting heart rate(3 months)
- The Simplifies Psoriasis Index(3 months)
- Hospital Anxiety and Depression Score(3 months)
- Penn State Worry questionnaire(3 months)
- Cantril Ladder scale(3 months)
- Insomnia severity index(3 months)
- Alcohol use disorders identification test; primary care(3 months)