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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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South Yorkshire
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Sheffield, South Yorkshire, 영국, S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Behaviour change intervention
Intensive behaviour change intervention for 3 months, followed by a maintenance phase for 3 months
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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. |
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다른: Wait-list Control
Usual care for 3 months, followed by intensive behaviour change intervention for 3 months
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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타당성 지표로 참여 초대를 수락한 환자의 비율
기간: 4 주
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4 주
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Proportion of people with CF who are randomised into the study after accepting the invitation to participate, as a marker of feasibility
기간: 4 weeks
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4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participants' opinion about the behavioural intervention
기간: 6 months
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6 months
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Participant attrition rate and phases of study whereby the attrition occurs
기간: 6 months
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6 months
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Participants' opinion about the study processes
기간: 6 months
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6 months
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Participants' suggestions for further improvement of the intervention and study processes
기간: 6 months
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6 months
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Proportion of adults who fulfils the BMI criteria for recruitment with IT facilities
기간: 2 weeks
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2 weeks
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Resources needed by the investigators to deliver the intervention
기간: 6 months
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6 months
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Proportion of days with missing nutritional data, as a marker for feasibility
기간: 6 months
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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.
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6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body mass index
기간: 6 months
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Unit is kg/m2
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6 months
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Weight
기간: 6 months
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unit is kg
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6 months
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Beliefs about Medicines Questionnaire (BMQ) score
기간: 6 months
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As a marker of patients' perception of their treatment
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6 months
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The mean Self-Report Behavioural Automaticity Index (SRBAI) score
기간: 6 months
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As a marker of habit formation
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6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Martin J Wildman, PhD, Sheffield Teaching Hospitals NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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