Efficacy of Nursing Intervention "Teaching: Individual" to Increase Adherence to Therapeutic Regimen in People With Hypertension Arterial and/or Diabetes Mellitus Type 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Changes of mean score adherence to treatment from baseline at 6 and 12 months
研究概览
简要总结
The purpose of this study is to improve the adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing intervention "Teaching: Individual", is more effective to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual care.
详细描述
Introduction
The hypertension arterial and diabetes mellitus are chronic diseases with a high burden of disease. It affects approximately 25% of the adult population worldwide and is an important risk factors for global mortality. As for the diabetes, worldwide there are about 346 million people with diabetes and 80% of them live in countries with low and middle income. The recommendations for treating of these diseases includes the pharmacological treatment and modification of lifestyle: salt restriction, moderation in alcohol consumption, high consumption of fruits and vegetables, low-fat diet, weight reduction and regular physical activity. The adherence to these guidelines are essential keys to success in handling these pathologies. The lack of adherence to the prescribed treatment regimen remains a problem among patients with long-term treatment.
Objective
To evaluated the efficacy of nursing intervention "Teaching: Individual" compared with usual care, to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2.
Methods: Randomized controlled trial. 200 patients with hypertension arterial and/or diabetes mellitus type 2 attending cardiovascular risk programs of Bucaramanga, Colombia will include . Nursing intervention to evaluate is "Teaching: Individual" consisting in six educational sessions. The investigators will measure 0, 6 y 12 months: Treatment Behavior: Illness or Injury (1609) (adherence treatment), glycosylated hemoglobin (HbA1c) and systolic blood pressure for 24 hours. Base characteristics of the groups will be compare through chi-square/Fisher´s exact or Students-T/Mann-Whitney U test. Outcomes will be evaluate by paired T-tests or Wilcoxon test at different follow-up times and statistical significance with p-value < 0.05 will considered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population ≥ 18 years old
- •Medical diagnosis of hypertension arterial and/or diabetes mellitus type
- •Attendees cardiovascular risk programs of Empresa Social del Estado Instituto de Salud de Bucaramanga (ISABU)
- •People totally independent of their care.
- •Access to a fixed telephone line or mobile itself
- •Be residents of Bucaramanga
排除标准
- •Changes in the mental sphere. Abbreviated Mental Test (Minimental) and Yesavage depression test.
- •Communication limitations or chronic or serious alterations that make it hard compression of interventions.
- •Subjects who are participating in a research study currently or during the last six months.
研究组 & 干预措施
Teaching: Individual (5606)
People will receive an education session per month for a period of six months with an average duration of 30 minutes. These will be performed by nurses outside the collection of phase base line and follow-up measurements, previously trained for the purpose.
干预措施: Teaching: Individual (5606) (Behavioral)
Usual care
People will continue to receive usual care in the health center where they usually assist to medical controls.
结局指标
主要结局
Changes of mean score adherence to treatment from baseline at 6 and 12 months
时间窗: 6 and 12 months
Measured by Treatment Behavior: Illness or Injury (1609)
次要结局
- Changes of mean systolic blood pressure from baseline at 6 and 12 months(6 and 12 months)
- Changes of mean score glycosylated hemoglobin from baseline at 6 and 12 months(6 and 12 months)
研究者
Sandra Lucrecia Romero Guevara
Nurse Research, MSc Nursing. Professor, School of Nursing. Universidad Industrial de Santander, Bucaramanga, Colombia.
Universidad Industrial de Santander