Pilot Study of Behavioural Intervention for Nutrition in Cystic Fibrosis (PIN-CF)
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 lung infections and reduced nutrients absorption from food. The average age at death is 26 years, usually from respiratory failure. Nonetheless, the nutritional status of people with CF (PWCF) is important help them live healthier and longer.
It is recommended that adult with CF achieve a BMI of 23 for males and 22 for females. However, fewer than 50% adult with CF achieved that target BMI despite effective nutritional support to help support 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. 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 the how many people are needed for the larger trial.
All eligible 75 PWCF in Sheffield will be invited to participate. The investigators anticipate recruiting 30 participants. Participants will be divided into two groups. The first group receive the behavioural intervention immediately. The second group receive the intervention after 3 months. All participants will be followed up for 6 months. Data will be collected every 6 weeks during clinic reviews.
These two groups will be compared against each other to estimate the potential impact of the behavioural intervention. The investigators will also interview some of the participants at the end of the study period to improve the intervention and the study processes based on participant feedback.
The investigators hypothesised that this study will recruit around 30 participants, around 80% of the participants will complete the study, a single full-time investigator can deliver the intervention to 15 participants over 3 months and data collection will be thorough (with less than 5% missing data). The investigators also hypothesised that this feasibility study will help improve the intervention and help the design of a larger trial.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Storbritannia, S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- adult people with CF looked after at the Sheffield Adult CF Unit
- best BMI of < 23 for males and < 22 for females between Oct '12 and Oct '13
Exclusion Criteria:
- patients in the palliative phase of disease
- patients who are pregnant
- patients who have no capacity to consent to participate in the study
- patients who have no IT facilities to use the web-based food diary
- patients who are unable to communicate by telephone for coaching
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Behaviour change intervention
Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months
|
The behaviour change intervention consists of
The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails. The maintenance phase consists of 3 telephone calls and 4 reminder emails. |
|
Annen: Wait-list Control
Usual care for 3 months, followed by intensive behaviour change intervention for 3 months
|
The behaviour change intervention consists of
The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails. The maintenance phase consists of 3 telephone calls and 4 reminder emails. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Andel pasienter som takket ja til invitasjon til å delta som en markør for gjennomførbarhet
Tidsramme: 4 uker
|
4 uker
|
|
Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
Tidsramme: 4 weeks
|
4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Participants' opinion about the behavioural intervention
Tidsramme: 6 months
|
6 months
|
|
|
Participant attrition rate and phases of study whereby the attrition occurs
Tidsramme: 6 months
|
6 months
|
|
|
Participants' opinion about the study processes
Tidsramme: 6 months
|
6 months
|
|
|
Participants' suggestions for further improvement of the intervention and study processes
Tidsramme: 6 months
|
6 months
|
|
|
Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
Tidsramme: 2 weeks
|
2 weeks
|
|
|
Resources needed by the investigators to deliver the intervention
Tidsramme: 6 months
|
6 months
|
|
|
Proportion of days with missing nutritional data, as a marker for feasibility
Tidsramme: 6 months
|
Participants are requested to fill in their nutritional intake daily on a web-based food diary.
The investigators are interested to find out what the proportion of such data will be missing to determine the feasibility of collecting data with the web-based food diary.
|
6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body mass index
Tidsramme: 6 months
|
Unit is kg/m2
|
6 months
|
|
Weight
Tidsramme: 6 months
|
unit is kg
|
6 months
|
|
Beliefs about Medicines Questionnaire (BMQ) score
Tidsramme: 6 months
|
As a marker of patients' perception of their treatment
|
6 months
|
|
The mean Self-Report Behavioural Automaticity Index (SRBAI) score
Tidsramme: 6 months
|
As a marker of habit formation
|
6 months
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Martin J Wildman, PhD, Sheffield Teaching Hospitals NHS Foundation Trust
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STH17327
- IRAS Project ID 139047 (Annen identifikator: Integrated Research Application System (IRAS))
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