Quality of Life in Pulmonary Rehabilitation: A Social Identity Based Intervention
A Pilot Study to Assess the Feasibility and Efficacy of a Social Identity Theory Based Intervention to Improve the Quality of Life of Patients Attending Pulmonary Rehabilitation.
調査の概要
詳細な説明
Previous research indicates that self-management interventions vary, comprising of patient education, action planning, goal setting, cognitive behavioural therapy and motivational interviewing. The delivery of these interventions was largely conducted through individual sessions either face-to-face or telephone conversations, or through the individual distribution of booklet information. As such, research has heavily focused on individual-focused self-management interventions in order to facilitate QoL in COPD patients. It is not surprising that interventions have largely taken an individualistic approach given that sufferers of COPD are diagnosed and treated as individuals (e.g., in hospital, or when visiting the doctor). However, at times COPD management is delivered in groups (e.g., exercise/ education rehabilitation sessions). Indeed, the group-management of COPD treatment for improving the QoL of COPD patients has largely remained unexplored. Therefore, a significant limitation of self-management approaches used to-date concerns the lack of consideration given to group-management interventions. The proposed study therefore aims to address this limitation by investigating the a group-based psychological intervention.
Participants will be assigned to one of two groups: 1) the control group containing standard care; and 2) the intervention group containing standard care plus the intervention. Participants will attend weekly rehabilitation classes for 8 weeks, regardless of the rehabilitation group assigned. In addition, participants will complete a quality of life questionnaire that will ask questions about subjective feelings. The questionnaire will take about 20 minutes to complete. The questionnaire will be completed at the start of the 8-week rehabilitation programme, at the mid-point, and at the end of the rehabilitation programme.
In the intervention arm of the study participants will take part in three focus group discussions. The focus group discussions will be with members of the research team and the rest of your rehabilitation group. The first two sessions help participants plan strategies in order to get the most benefit from the rehabilitation programme. The third session will entail some reflection regarding how well participants thought the programme had addressed their rehabilitation needs. Finally, all participants will complete the quality of life questionnaire again at 3 months after completing the 8-week rehabilitation programme by return stamp-addressed envelope.
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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-
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Liverpool、イギリス、L14 3PE
- Liverpool Heart & Chest Hospital
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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:
- Inclusion criteria are that patients score between 1 and 4 on the Modified Medical Research Council Dyspnoea Scale and have not previously been enrolled on a pulmonary rehabilitation programme
Exclusion Criteria:
- Patients excluded from the study based on these criteria will be assigned to a rehabilitation group not involved in the study.
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：他の
- 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：Social Identity Goal-Based Intervention
Participants will receive collaborative goal-setting
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Phase 1: collaborative group discussion in order to establish what group members want to achieve by the end of their 8-week pulmonary rehabilitation programme.
Phase 2: further collaborative group discussion with the emphasis on evaluating, monitoring, and providing feedback on goal attainment.
Phase 3: focus group interviews with an emphasis on reviewing the goal setting process that patients have engaged with.
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介入なし：Standard Care
Participants will receive usual standard treatment
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Health-related Quality of Life (QoL) scores from baseline
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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QoL measured using Euroquol EQ-5D-3L and 5L questionnaires
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Baseline, 4 weeks, 8 weeks, 12 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 |
|---|---|---|
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Change in magnitude of social identification score measured using a standardised scale from baseline
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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The intervention fidelity will be assessed through determining whether social identification has been achieved.
This will be measured with four items (from Doosje, Ellemers, & Spears, 1995; e.g.
'Do you see yourself as part of the [COPD exercise group]', 'Are you pleased to be part of the [COPD group]', 'Do you feel strong ties with others in the [COPD exercise group]?', 'Do you identify with others in the [COPD exercise group].
These scales are widely used and amended in this form and are generally found to provide a good index of the theoretical construct of social identification (e.g.
see Haslam et al., 2004).
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Change in disease-specific quality of life (QoL) scores from baseline
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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This will be determined using the Chronic Respiratory Questionnaire and the St George's Respiratory Questionnaires.
Additionally, the Survey Short Form (SF-36) will also be administered
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Baseline, 4 weeks, 8 weeks, 12 weeks
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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 |
|---|---|---|
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Change in anxiety and depression scores from baseline
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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These will be determined using the Hospital and Anxiety and Depression Scale questionnaire
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Baseline, 4 weeks, 8 weeks, 12 weeks
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Change in exercise adherence rates from baseline
時間枠：Baseline, 4 weeks, 8 weeks
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This is defined as the number of prescribed exercise sessions performed
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Baseline, 4 weeks, 8 weeks
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Change in functional capacity score from baseline
時間枠：Baseline, 4 weeks, 8 weeks
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This is defined as total distance covered in a 6 minutes walk test.
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Baseline, 4 weeks, 8 weeks
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Healthcare resources use
時間枠：12 weeks
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We will assess the use of healthcare resources.
We will specifically examine the issue of staff time in association with the delivery of the social identity intervention.
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12 weeks
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Cost-effectiveness
時間枠：12 weeks
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and conduct a cost-effectiveness analysis.
We will assess the incremental costs per QALY both from the NHS and societal perspectives.
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12 weeks
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協力者と研究者
捜査官
- スタディディレクター：Bashir Matata, PhD、Liverpool Heart & Chest Hospital
出版物と役立つリンク
一般刊行物
- Iyer A, Jetten J, Tsivrikos D, Postmes T, Haslam SA. The more (and the more compatible) the merrier: multiple group memberships and identity compatibility as predictors of adjustment after life transitions. Br J Soc Psychol. 2009 Dec;48(Pt 4):707-33. doi: 10.1348/014466608X397628. Epub 2009 Feb 5.
- Haslam SA, O'Brien A, Jetten J, Vormedal K, Penna S. Taking the strain: social identity, social support, and the experience of stress. Br J Soc Psychol. 2005 Sep;44(Pt 3):355-70. doi: 10.1348/014466605X37468.
- Veenstra K, Haslam SA, Reynolds KJ. The psychology of casualization: evidence for the mediating roles of security, status and social identification. Br J Soc Psychol. 2004 Dec;43(Pt 4):499-514. doi: 10.1348/0144666042565380.
- Levy AR, Matata B, Pilsworth S, Mcgonigle A, Wigelsworth L, Jones L, Pott N, Bettany M, Midgley AW. An intervention for pulmonary rehabilitators to develop a social identity for patients attending exercise rehabilitation: a feasibility and pilot randomised control trial protocol. Pilot Feasibility Stud. 2018 Jan 27;4:40. doi: 10.1186/s40814-018-0238-z. eCollection 2018.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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