10 Prescriptions an Hour. Group Treatment and Physical Activity Referral in a Primary Health Care Setting (10PAR)
Randomized Controlled Trial of Group Treatment With Physical Activity Referral in a Primary Health Care Setting
調査の概要
詳細な説明
A sedentary lifestyle and low levels of physical activity in populations are major health problems today and contribute substantially to poor health and diseases such as type 2 diabetes and hypertension. An increased and systematic effort to increase physical activity in the Swedish population in general, and in patients with type 2 diabetes/hypertension in particular, is important. Written prescriptions of physical activity with follow-up (i.e., PAR), is a cost-efficient way to increase physical activity in individuals.
The aim of this trial is to study whether physical activity is increased by a group method involving PARs in patients with hypertension and/or type 2 diabetes compared with a control group that receives usual care in the same primary care setting. Follow-up will be performed at 6 and 12 months.
This trial is being conducted to determine whether it is possible to offer PARs to more patients in a way that requires less effort and resources. The intervention in this study requires 10 minutes of a health care worker's time per patient during a 6-month period. Each patient requires 100 minutes with an instructor who oversees the group intervention.
Group treatment is given 3 weeks after baseline and at 6 months. Follow-up at 12 months involves data collection, but no intervention.
An empowerment process, with the 5-A-model as framework, will be used in the clinical intervention.
All participants will be required to fill in questionnaires and wear an ActiGraph GTM1/GTM3 for 7 days at baseline and at 6 and 12 months.
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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Malmö、スウェーデン
- Center for Primary Health Care Research, Lund University/Region Skane
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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:
- Clinical diagnosis of hypertension or type 2 diabetes since 10-09-2009 at St Hans Primary Health Care Center, Lund, Sweden
Exclusion criteria:
- Dementia
- Psychosis
- Drug abuse
- Mental retardation
- Inability to walk without assistance
- Inability to speak Swedish
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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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介入なし：普段のお手入れ
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実験的：Group treatment and PAR
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Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR.
Two group sessions, 6 months apart.
The estimated total time for both group sessions together is 100 minutes.
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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 |
|---|---|---|
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Physical activity level
時間枠：Up to 1 year
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Physical activity level is measured with an Actigraph GTM1/3.
Overall physical activity, and total accumulated time and bouts of time in different categories of physical activity, will be determined according to count thresholds.
Additonally subjective measurements of physical acidity are made using a questionnaire were questions about self-reported physical activity are reported (the International Physical Activity Questionnaire; IPAQ).
Subjectively measured physical activity will be expressed as MET-minutes/week.
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Up to 1 year
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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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Quality of life, measured using the EQ-5D questionnaire
時間枠：1 year
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EQ-5D, a validated instrument that classifies health according to five items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), each of which has three alternatives ("no problem", "moderate problem" and "severe problem").
Combining the answers gives an index with a score of between 0.59 and 1.0.
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1 year
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協力者と研究者
スポンサー
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。
Group treatment and PARの臨床試験
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Washington State UniversityNational Institute on Drug Abuse (NIDA)完了