PsoriasisNCT06726213
Walk and Talk: Connecting People With Psoriasis
A study testing Walk and talk in people with Psoriasis and Social Isolation, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Social Isolation
- What is being tested?
- Walk and talk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Free
London, Greater London, NW3 2QG
Sandy McBride, Dr, 0207 794 0500 ext. 38134, sandy.mcbride@nhs.net
Poppy S Scheinmann, BSc, 07952560069, poppy.scheinmann@nhs.net
About this study
Official title: '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
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)
Read more
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
Read the detailed description
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. Choosing not to participate will not alter their current or future care in any way. The 'opt out' study design has been chosen so the investigators can see if the people who participate in the study are representative of the overall population of patients who attend the Royal Free Hospital Psoriasis service. The investigators are keen to understand whether a social intervention such as a Walk and Talk intervention is acceptable to all subgroups of patients particularly with respect to ethnicity, gender, age and body mass index (weight).
- INTERVENTION
- RANDOMISATION RANDOMISATION: Participants who have consented to participate in the study will be randomised using a computer-generated randomisation process to either a control group or a Walk and Talk (intervention) group at a 1:1 ratio. Participants who are in the intervention group will be allocated to a specific Walk and Talk group based on time and day of the week that is most convenient for them. A control group is included as this is an exploratory study. There have not been previous studies exploring the effect of a social intervention on people with psoriasis. The investigators are therefore interested to see potential areas for further investigation, such as improvement in quality of life, or social connectedness. The investigators need a control group to explore what differences there are for people participating in the social intervention, compared with those who are not participating in the intervention.
- BASELINE DATA COLLECTION (Time point 1) All participants will attend at a separate time to their usual dermatology outpatient appointment at the Royal Free Hospital to have baseline data collected (Time Point 1 - Figure 1). This will take approximately 30 mins. Questionnaires are validated questionnaires used in previous studies (Appendix 1.). Data collection will comprise of a variety of assessments to measure demographic, cardiovascular risk, disease severity quality of life, mood and wellbeing, lifestyle and medication.
Assessments for the control and the intervention groups will be at 4 time points:
- Baseline
- After 4 walk and talk sessions, (week 8) of the study; A short (15 minute) telephone interview will be performed for the participants in the intervention group to determine if any changes to the format of the Walk and Talk Intervention need to be made.
- At completion of the 8 session Walk and Talk intervention (week 16 of study) Some participants in the intervention group will be randomly selected using the same randomisation process as described earlier to participate in an in-depth semi-structured interview). All participants will have the same data collected as they did in the baseline data collection.
- 3 months after the end of the 8 session Walk and Talk intervention (week 28 of study), all participants will have their data collected again as they did in baseline, participants in the intervention group will out an additional questionnaire to assess whether they have continued to use the intervention after the end of the study.
Semi-structured interview:
Semi-structured digitally recorded interviews will be conducted by a member of the research team. Questions will focus on the participants' experience of the Walk and Talk intervention. Areas they enjoyed, changes they'd make for future interventions and any positive changes they've experiences as a result of the intervention. (see Appendix). The next round of 'Walk and Talk' interventions will be adapted according to feedback from these interviews.
INTERVENTION GROUP:
The intervention is a Group Walking Intervention (Walk and Talk Group), led by a trained walking leader who will be external to the trust. The walking leader will have no access to participant information other than a list of names of the participants in their particular group. The 'Walk and Talk' group will meet on 8 occasions for 1 hour to walk outside in a park every 2 weeks, it will take place on the same day/time and comprise of the same group participants and walk leader. There will be 8-10 participants in each group. It will involve walking with some simple stretches. The speed of the walk will be guided by the group level.
Each member of the intervention group will:
(i) Attend a virtual 'meet and greet' meeting with their group members (ii) Watch a short film about living with psoriasis at the end of the virtual meet and greet session (iii) Attend 8 x 1 hour outdoor walking sessions as above
Meet and Greet Zoom Call A week prior to the first Walk and Talk session, a Zoom 'meet and greet' call will be arranged where members of the group and the group leader will meet virtually for the first time. The session will be introduced by the PI who will be familiar to most participants and run by the study coordinator. Details of the study will be described briefly. Guidelines for behaviours and group responsibilities will be shared. Participants will be given the opportunity to ask questions. A psychologist will attend and silently observe.
Short Film Participants will be asked to watch the film 'Psoriasis: The Skin I'm In' at the end of the zoom call. The film is 11 minutes long and depicts true stories of people living with psoriasis. The aim of participants watching the film is to encourage discussion about psoriasis within the group. Focused groups suggested this be watched at home as it is quite emotional and would be difficult to watch in a group. The decision to ask participants to watch it as part of the zoom rather than completely independently is because it ensures a more focused environment and the investigators know that the film has been watched. To ensure participants feel comfortable, participants will be requested to turn off their cameras and microphones during the screening of the film. If they feel distressed they are able to leave the zoom without having to rejoin afterwards. A psychologist will be attending the zoom call and will be available for participants to speak to if needed.
Members of each walking group will be invited to join a WhatsApp Group (see Appendix) to enable participants to meet outside of the designated Walk and Talk intervention and to allow information about any group changes to be communicated. This will be voluntary. A member of the research team will also be part of the group to monitor for any inappropriate behaviours.
Group members will sign a 'Code of Conduct' (see Appendix) regarding use of What's App and conversations during the group activity.
CONTROL GROUP Participants in the control group will continue to receive standard psoriasis care delivered by the hospital but will not enter into a Walk and Talk group.
OTHER PARAMETERS In this pilot study the investigators will determine factors affecting recruitment and retention in the study. The investigators will determine if study participants are representative of the wider population of patients attending the Royal Free Psoriasis Service eg in sex, age, BMI and ethnicity. The investigators will determine if attendance of the Walk and Talk groups is dependent on external factors such as the weather, time of year or time of day, the exercise professional or mixed or same sex groups. Or if attendance is governed by patient factors such as age or sex. Similar factors for on-going adherence to increased activity and group relationships will be examined.
- ANALYSIS
- Qualitative analysis Semi-structured post-intervention interviews Randomly selected individuals who have completed the Walk and Talk intervention will be contacted and asked for an informal interview to discuss their experience of participating in a Walk and Talk group. The interviews will be semi-structured (similar questions will be asked at each interview, but there will be scope for conversation to naturally evolve too). The interviews will be recorded and transcribed. At least 2 researchers will analyse the transcripts independently and identify key recurring themes. The number of participants who are called for interview will depend upon 'saturation of themes'. Once no new information is being gathered from participants, themes will be considered saturated and no more interviews will take place. Information gathered from the interviews will be used to inform the ideal design of a Walk and Talk intervention for people with psoriasis. This design can then be used for a future fully powered definitive study.
- Quantitative analysis
Statistical analysis will be descriptive only as there have been no previous studies to determine how many participants are needed in order to draw statistically significant results from the data.
The investigators will use the data gathered from this study to determine meaningful primary and secondary endpoints for a future study and also to calculate how many participants are needed for a future study to be statistically significant ie perform a power calculation.
- Conditions
- Psoriasis, Social Isolation
- Being tested
- Walk and talk
- Medical subject headings
- Psoriasis, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk and talkOther
An hour long walk at a slow pace lead by a trained walking leader.
| Study group | Role | What they receive |
|---|---|---|
| walk and talk group | Experimental | Participants will participate in a walk and talk intervention once every two weeks for a 16-week period. Receives: Other: Walk and talk |
| Control group | No intervention | Participants will continue their usual treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction of a of a Walk and Talk intervention for people living with psoriasis.
Found by looking at feedback and comments of participants in thematic analysis of semi-structured interview.
Measured: 3 months
Secondary outcomes (15)
General Practice Physical Activity Questionnaire
A 4-level scale measuring how long the participant spends doing various types of physical activity. From none - 3 hours. A higher score shows higher levels of physical activity.
Measured: 3 months
Psoriasis Area and Severity Index
A 4-level scale where participants rate different symptoms of psoriasis from 0 mild - 4 severe. A higher score reflects worse disease severity.
Measured: 3 months
Dermatology Life Quality Index (DLQI) questionnaire
A 4-level scale with questions about the participants skin condition. Answers are on a scale from 'very much' to 'not at all'. A higher score indicates poorer quality of life.
Measured: 3 months
Medication Adherence Questionnaire (MAQ)
A 2-level scale where participants answer Yes of No to questions concerning their medication. A higher score reflects lower adherence.
Measured: 3 months
To understand the participants' experience of a weekly 'walk and talk' activity
Thematic analysis of semi-structured interviews.
Measured: 3 months
Body mass index
Weight in kilograms divided by height in metres squared
Measured: 3 months
Abdominal circumference
Measures in centimetres
Measured: 3 months
Blood pressure
Systolic and diastolic blood pressure will be taken using a blood pressure cuff. It will be recorded as systolic pressure over the diastolic pressure in mm/Hg
Measured: 3 months
Resting heart rate
Will be counted by a member of the research team
Measured: 3 months
The Simplifies Psoriasis Index
This scale is in 3 parts. Part 1 provides a score from 0-50 of psoriasis severity, a higher score means it's more severe. Part 2 measures psychosocial impact, the participant marks their answer on a horizontal line from 0-10 with a higher score reflecting a higher psychosocial impact. Part 3 records how the Psoriasis has behaved and been treated in the past with a series of tick boxes. Scored are combines and a higher score reflects a larger impact.
Measured: 3 months
Hospital Anxiety and Depression Score
A 4-level scale measuring participants agreement to statements about mood and feelings. A higher score reflects higher levels of anxiety and depression.
Measured: 3 months
Penn State Worry questionnaire
A 4-level scale measuring participants frequency of worrying from 'Not at all typical' to 'Very typical of me'. A higher score reflects higher levels of worry
Measured: 3 months
Cantril Ladder scale
A scale from 1-10. Participants select their position based on satisfaction with their life. A higher score reflects more satisfaction.
Measured: 3 months
Insomnia severity index
A 5-level scale with questions about quality of sleep. A higher score reflects higher levels of insomnia.
Measured: 3 months
Alcohol use disorders identification test; primary care
A 4-level scale rating the frequency and volume of alcohol intake. A higher score reflects higher chance of alcoholism.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start7 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726213
- Sponsor's protocol ID
- WALKANDTALK1.0
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- '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
- ClinicalTrials.gov ID
- NCT06726213
- Acronym / sponsor ID
- WALKANDTALK1.0
- Conditions
- Psoriasis, Social Isolation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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. Choosing not to participate will not alter their current or future care in any way. The 'opt out' study design has been chosen so the investigators can see if the people who participate in the study are representative of the overall population of patients who attend the Royal Free Hospital Psoriasis service. The investigators are keen to understand whether a social intervention such as a Walk and Talk intervention is acceptable to all subgroups of patients particularly with respect to ethnicity, gender, age and body mass index (weight).
- INTERVENTION
- RANDOMISATION RANDOMISATION: Participants who have consented to participate in the study will be randomised using a computer-generated randomisation process to either a control group or a Walk and Talk (intervention) group at a 1:1 ratio. Participants who are in the intervention group will be allocated to a specific Walk and Talk group based on time and day of the week that is most convenient for them. A control group is included as this is an exploratory study. There have not been previous studies exploring the effect of a social intervention on people with psoriasis. The investigators are therefore interested to see potential areas for further investigation, such as improvement in quality of life, or social connectedness. The investigators need a control group to explore what differences there are for people participating in the social intervention, compared with those who are not participating in the intervention.
- BASELINE DATA COLLECTION (Time point 1) All participants will attend at a separate time to their usual dermatology outpatient appointment at the Royal Free Hospital to have baseline data collected (Time Point 1 - Figure 1). This will take approximately 30 mins. Questionnaires are validated questionnaires used in previous studies (Appendix 1.). Data collection will comprise of a variety of assessments to measure demographic, cardiovascular risk, disease severity quality of life, mood and wellbeing, lifestyle and medication.
Assessments for the control and the intervention groups will be at 4 time points:
- Baseline
- After 4 walk and talk sessions, (week 8) of the study; A short (15 minute) telephone interview will be performed for the participants in the intervention group to determine if any changes to the format of the Walk and Talk Intervention need to be made.
- At completion of the 8 session Walk and Talk intervention (week 16 of study) Some participants in the intervention group will be randomly selected using the same randomisation process as described earlier to participate in an in-depth semi-structured interview). All participants will have the same data collected as they did in the baseline data collection.
- 3 months after the end of the 8 session Walk and Talk intervention (week 28 of study), all participants will have their data collected again as they did in baseline, participants in the intervention group will out an additional questionnaire to assess whether they have continued to use the intervention after the end of the study.
Semi-structured interview:
Semi-structured digitally recorded interviews will be conducted by a member of the research team. Questions will focus on the participants' experience of the Walk and Talk intervention. Areas they enjoyed, changes they'd make for future interventions and any positive changes they've experiences as a result of the intervention. (see Appendix). The next round of 'Walk and Talk' interventions will be adapted according to feedback from these interviews.
INTERVENTION GROUP:
The intervention is a Group Walking Intervention (Walk and Talk Group), led by a trained walking leader who will be external to the trust. The walking leader will have no access to participant information other than a list of names of the participants in their particular group. The 'Walk and Talk' group will meet on 8 occasions for 1 hour to walk outside in a park every 2 weeks, it will take place on the same day/time and comprise of the same group participants and walk leader. There will be 8-10 participants in each group. It will involve walking with some simple stretches. The speed of the walk will be guided by the group level.
Each member of the intervention group will:
(i) Attend a virtual 'meet and greet' meeting with their group members (ii) Watch a short film about living with psoriasis at the end of the virtual meet and greet session (iii) Attend 8 x 1 hour outdoor walking sessions as above
Meet and Greet Zoom Call A week prior to the first Walk and Talk session, a Zoom 'meet and greet' call will be arranged where members of the group and the group leader will meet virtually for the first time. The session will be introduced by the PI who will be familiar to most participants and run by the study coordinator. Details of the study will be described briefly. Guidelines for behaviours and group responsibilities will be shared. Participants will be given the opportunity to ask questions. A psychologist will attend and silently observe.
Short Film Participants will be asked to watch the film 'Psoriasis: The Skin I'm In' at the end of the zoom call. The film is 11 minutes long and depicts true stories of people living with psoriasis. The aim of participants watching the film is to encourage discussion about psoriasis within the group. Focused groups suggested this be watched at home as it is quite emotional and would be difficult to watch in a group. The decision to ask participants to watch it as part of the zoom rather than completely independently is because it ensures a more focused environment and the investigators know that the film has been watched. To ensure participants feel comfortable, participants will be requested to turn off their cameras and microphones during the screening of the film. If they feel distressed they are able to leave the zoom without having to rejoin afterwards. A psychologist will be attending the zoom call and will be available for participants to speak to if needed.
Members of each walking group will be invited to join a WhatsApp Group (see Appendix) to enable participants to meet outside of the designated Walk and Talk intervention and to allow information about any group changes to be communicated. This will be voluntary. A member of the research team will also be part of the group to monitor for any inappropriate behaviours.
Group members will sign a 'Code of Conduct' (see Appendix) regarding use of What's App and conversations during the group activity.
CONTROL GROUP Participants in the control group will continue to receive standard psoriasis care delivered by the hospital but will not enter into a Walk and Talk group.
OTHER PARAMETERS In this pilot study the investigators will determine factors affecting recruitment and retention in the study. The investigators will determine if study participants are representative of the wider population of patients attending the Royal Free Psoriasis Service eg in sex, age, BMI and ethnicity. The investigators will determine if attendance of the Walk and Talk groups is dependent on external factors such as the weather, time of year or time of day, the exercise professional or mixed or same sex groups. Or if attendance is governed by patient factors such as age or sex. Similar factors for on-going adherence to increased activity and group relationships will be examined.
- ANALYSIS
- Qualitative analysis Semi-structured post-intervention interviews Randomly selected individuals who have completed the Walk and Talk intervention will be contacted and asked for an informal interview to discuss their experience of participating in a Walk and Talk group. The interviews will be semi-structured (similar questions will be asked at each interview, but there will be scope for conversation to naturally evolve too). The interviews will be recorded and transcribed. At least 2 researchers will analyse the transcripts independently and identify key recurring themes. The number of participants who are called for interview will depend upon 'saturation of themes'. Once no new information is being gathered from participants, themes will be considered saturated and no more interviews will take place. Information gathered from the interviews will be used to inform the ideal design of a Walk and Talk intervention for people with psoriasis. This design can then be used for a future fully powered definitive study.
- Quantitative analysis
Statistical analysis will be descriptive only as there have been no previous studies to determine how many participants are needed in order to draw statistically significant results from the data.
The investigators will use the data gathered from this study to determine meaningful primary and secondary endpoints for a future study and also to calculate how many participants are needed for a future study to be statistically significant ie perform a power calculation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| walk and talk group | Experimental | Other: Walk and talkParticipants will participate in a walk and talk intervention once every two weeks for a 16-week period. |
| Control group | No intervention | –Participants will continue their usual treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk and talkAn hour long walk at a slow pace lead by a trained walking leader. | Other | walk and talk group |
Primary outcome
Participant satisfaction of a of a Walk and Talk intervention for people living with psoriasis.
Time frame: 3 months
Found by looking at feedback and comments of participants in thematic analysis of semi-structured interview.
15 secondary outcomes
General Practice Physical Activity Questionnaire
Time frame: 3 months
Psoriasis Area and Severity Index
Time frame: 3 months
Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 3 months
Medication Adherence Questionnaire (MAQ)
Time frame: 3 months
To understand the participants' experience of a weekly 'walk and talk' activity
Time frame: 3 months
Body mass index
Time frame: 3 months
Abdominal circumference
Time frame: 3 months
Blood pressure
Time frame: 3 months
Resting heart rate
Time frame: 3 months
The Simplifies Psoriasis Index
Time frame: 3 months
Hospital Anxiety and Depression Score
Time frame: 3 months
Penn State Worry questionnaire
Time frame: 3 months
Cantril Ladder scale
Time frame: 3 months
Insomnia severity index
Time frame: 3 months
Alcohol use disorders identification test; primary care
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk and talk in people with Psoriasis and Social Isolation, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction of a of a Walk and Talk intervention for people living with psoriasis. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.