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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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South Yorkshire
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Sheffield、South Yorkshire、イギリス、S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
|
他の：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
実現可能性の指標として参加への招待を受け入れた患者の割合
時間枠：4週間
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4週間
|
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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
時間枠：4 weeks
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4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participants' opinion about the behavioural intervention
時間枠：6 months
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6 months
|
|
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Participant attrition rate and phases of study whereby the attrition occurs
時間枠：6 months
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6 months
|
|
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Participants' opinion about the study processes
時間枠：6 months
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6 months
|
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Participants' suggestions for further improvement of the intervention and study processes
時間枠：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
時間枠：2 weeks
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2 weeks
|
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Resources needed by the investigators to deliver the intervention
時間枠：6 months
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6 months
|
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Proportion of days with missing nutritional data, as a marker for feasibility
時間枠：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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body mass index
時間枠：6 months
|
Unit is kg/m2
|
6 months
|
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Weight
時間枠：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
時間枠：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
時間枠：6 months
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As a marker of habit formation
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6 months
|
協力者と研究者
捜査官
- 主任研究者：Martin J Wildman, PhD、Sheffield Teaching Hospitals NHS Foundation Trust
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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