跳至主要内容
临床试验/NCT01187576
NCT01187576撤回不适用

A Multi-professional Team Intervention on Physical Activity Referrals in Primary Care Patients With Cardiovascular Risk factors-the Dalby Lifestyle Intervention Cohort Study (DALICO) Study

Region Skane1 个研究点 分布在 1 个国家开始时间: 2010年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
Region Skane
试验地点
1
主要终点
to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both.

研究概览

简要总结

Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than ordinary physical activity recommendations. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes.

Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, lifestyle brochure; 2) Control group A (CA): ordinary recommendations on health behaviours, lifestyle brochure; and 3) Control group B: treatment as usual (retrospective data collection).

The intervention is based on self-determination theory and follows the principles of motivational interviewing. Physical activity is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides instant feed-back on the patients' health status.

Cost-effectiveness of the intervention is evaluated continuously and the intermediate

  • 3 - outcomes of the intervention are extrapolated by economic modelling. The first statistical analyses and compilation of results will be performed one year after inclusion of the first patient or when the IG and CA have included 60 and 30 eligible patients respectively. Discussion By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed type 2 diabetes or hypertension or both and consecutive primary care patients with suspected type 2 diabetes or hypertension will be screened for inclusion. The diagnose criterion for type 2 diabetes in both the Intervention and the Control groups is defined as a 2 x fasting plasma glucose (fP-glu) ≥ 7.0 mmol/l according to WHO guidelines [29]. The diagnose criterion for hypertension is defined as a resting systolic blood pressure ≥ 140 mmHg or a diastolic blood pressure ≥ 90 mmHg. Hypertension is confirmed by a 24-hour ambulatory blood pressure monitoring: a systolic blood pressure ≥ 135 mmHg and/or a
  • 13 - diastolic blood pressure ≥ 85 mmHg

排除标准

  • 未提供

研究组 & 干预措施

retrospective med history comparison

No Intervention

Treatment as usual (retrospective data collection)

Conventional treatment

Active Comparator

Ordinary recommendations on health behaviours, lifestyle brochure

干预措施: Ordinary recommendations on health behaviours, lifestyle brochure (Behavioral)

Intervention

Experimental

Multi-professional team intervention with PAR, lifestyle brochure

干预措施: Multi-professional team intervention with PAR, lifestyle brochure (Behavioral)

结局指标

主要结局

to examine whether an extended multi-professional PAR intervention, based on SDT, is effective in increasing and maintaining the self-reported physical activity level in patients with newly diagnosed type 2 diabetes or hypertension or both.

时间窗: every 6 months

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Sponsor

研究点 (1)

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