Evaluation of a Behavioural Intervention Using App Technology in CF

Study Overview
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Brief Summary
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Cystic Fibrosis (CF) is a lifelong condition which causes the lungs and digestive system to become clogged with thick, sticky mucus. This leads to recurrent chest infections and reduced nutrient absorption from food. The average age at death is 31 years, usually from respiratory failure. The nutritional status of people with CF (PWCF) is important to help them live healthier and longer. It is recommended that adults with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% of adults with CF achieved that target BMI despite effective nutritional support to help weight gain. There is a clear need for a behavioural intervention that can help PWCF use the available nutritional support. This is a feasibility study to try out a multi-component behavioural intervention supported by a nutrition app. The intervention is designed to help PWCF use their nutritional support to gain weight. It will focus on testing the methods and procedures to be used on a larger scale, improving the behavioural intervention and estimating how many people are needed for the larger trial. Eligible patients will be invited to participate, and the investigators anticipate recruiting 6 participants. The participants will have 6 weeks of intensive intervention, which will include a mix of clinic visits, home visits and telephone calls followed by 6 weeks of maintenance phase. Data will be collected during clinic visits at baseline, week 6 and week 12 along with weight monitoring at home. The investigators will interview each participant at the end of the study period to improve the intervention and study processes based on participant feedback. The investigators hypothesised that using a nutrition app, along with regular input from a dietitian, will help PWCF to use the available nutritional support.

Official Title
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Evaluation of a Behavioural Intervention Using App Technology in Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Behaviour change intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult people with CF looked after at the Sheffield Adult CF Centre best BMI of <23 for males and <22 for females between June 2018 and November 2018 Exclusion Criteria: patients in palliative phase of disease patients who are pregnant patients who have no capacity to consent to participate in the study patients who are unable to communicate by telephone for coaching

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behaviour change intervention<br>Intensive behaviour change for 6 weeks, followed by a maintenance phase for 6 weeks | Behavioral: Behaviour change intervention<br>* The behaviour change intervention consists of; Feedback via an app based food diary Coaching with problem solving and implementation plans The intensive phase consists of 2 home visits and 4 phone calls and the use of the app The maintenance phase consists of use of the app if the PWCF wishes to continue using it<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who accepted invitation to participate as a marker of feasibility |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' opinion about the behavioural intervention | A semi-structured interview will be used for thematic analysis | 3 months | 
| Participant attrition rate and phases of the study whereby the attrition occurs |  | 3 months | 
| Participants' opinion about the study processes | A semi-structured interview will be used for thematic analysis | 3 months | 
| Participants' suggestions for further improvement of the intervention and study processes | A semi-structured interview will be used for thematic analysis | 3 months | 
| Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities |  | 4 weeks | 
| Resources (time) needed by the investigators to deliver the intervention | Time will be used as a measurement tool to quantify total time required to deliver the intervention | 3 months | 
| Proportion of days with missing nutritional data, as a marker of feasibility |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Weight, BMI, Behaviour change