Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,728
- 试验地点
- 6
- 主要终点
- Rate of medical resource utilization
研究概览
简要总结
The goal of this randomized clinical trial is to learn if a nurse-led primary healthcare intervention can help improve health management in women adults aged 45 to 64, and to develop an evidence-based primary healthcare model for women. The questions it aims to answer are:
if the intervention improves medical resource use, especially at 3-month from the beginning of intervention? if the intervention improves health confidence, self-management, and quality-of-life? if the intervention improves health conditions as reflected by risk levels?
Researchers will compare the intervention with the control group over time to see if there are better medical resource use, health confidence, self-management, and quality-of-life, and health conditions risk levels.
All participants will be asked to answer a set of questionnaires assessing their social demographics, health-related status, and risk levels of the targeted health conditions. All participants will receive an education booklet containing essential knowledge and available medical resources. Participants in the intervention group will receive nurse-led 5As (ask, advice, assess, assist, arrange) intervention which offers risk-specific health services. Participants will be followed at 3-, 6-, 12-month; with high risk participants will be followed additionally at 1-month after the beginning of intervention. Participants in the waitlist control group will be given general health advice as minimal intervention, followed-up at 3- and 6-month, provided with intervention of the same content with intervention group at 6-month, followed-up at 7-month and 12-month.
详细描述
Background:
Globally, the aging population is on the rise, leading to the phenomenon known as the "feminization of aging" (United Nations, 2017). In most regions, women outlive men and face an increased risk of severe illnesses and multiple health conditions, significantly impacting their quality of life (Chłoń-Domińczak et al., 2014). In Hong Kong, the Family Health Service of the Department of Health provides the Woman Health Services including health assessment, health education, and individual counseling at three Woman Health Centres (WHCs) to women aged at or below 64 years, and its coverage is very limited. Hence, there is a lack of evidence-based services in primary healthcare settings such as DHCs for identifying and stratifying health risks among women and effective interventions in promoting women's health, particularly for those older female adults.
Nurse-led intervention is an intervention where nurses play central roles and have autonomous rights in decision-making as well as authority in customizing patient care (Li et al., 2020). Despite the important role of nurses in primary health care, this is no innovative nurse-led intervention model targeting women's health in Hong Kong.
The '5As model', which was initially developed for smoking cessation based on changes to different stages within the healthcare intervention (Wang et al., 2019), consists of five main steps: identifying health status and behavior for each individual (Ask), advising and urging the behavioral changes (Advice), assessing the willingness and readiness to change (Assess), providing supports and referrals to individuals willing to change (Assist), and scheduling follow-ups to address barriers and discuss personal progress (Arrange). It has been found to be an effective and simple model for nurses to deliver healthcare promotion and education intervention in community (Kolac et al., 2023; Slev et al., 2020). Brief intervention model as such would be much more feasible in PHC settings (Saitz et al., 2010).
As women reach the middle stage of their life between the ages of 45 and 64, a significant number of them undergo hormonal changes linked to the transitions through menopause. These changes often lead to the emergence of novel health challenges (Nasreen et al., 2021). Apart from the commonly observed age-related risk of developing colorectal cancer, more prevalent conditions affecting women in this life phase are vasomotor symptoms (VMS), urinary incontinence (UI), depression and anxiety, osteoporosis, breast cancer, hypertension, and cervical cancer. Hence, based on the 5As model, a nurse-led risk-based primary healthcare intervention is proposed for women's health management in Hong Kong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Hong Kong female residents aged 45 to 64 years old; and
- •Able to read and communicate in Chinese (either Cantonese or Mandarin).
排除标准
- •Have a terminal illness (e.g., advanced cancer, dementia, pulmonary, neurological, motor-neuron, and advanced cardiovascular disease), or with a life expectancy of less than six months;
- •Diagnosed with psychiatric or psychological disorders (e.g., panic disorder, psychosis);
- •Currently taking medication(s) or receiving treatment(s) for psychiatric and psychological disorders;
- •Pregnant or in lactation period, or have plans for pregnancy within 1 year; or
- •Have moderate or severe cognitive impairment.
结局指标
主要结局
Rate of medical resource utilization
时间窗: 3-month from baseline
Defined as completion of any referral (Women Health Centres or Maternal and Child Health Centres listed by the Depratment of Health, Kwong Wah Hospital Well Women Clinic, Tung Wah Group of Hospitals Well Women Clinic (North Point), Hong Kong Adventis Hospital Well Women Clinic, Women's Health Service by The Family Planning Association of Hong Kong, Canossa Hospital Health Check Centre, Primary Healthcare Directory Doctors, Hong Kong Breast Cancer Foundation Jockey Club Holistic Breast Health Project, Chronic-Disease Co-Care Pilot Scheme by Distric Health Centres, Colorectal Cancer Screenings (including Fecal Occult Blood Test, Sigmoidoscopy, or Colonoscopy), Jockey Club Holistic Support Project for Elderly Mental Wellness (JC JoyAge), or Integrated Community Centre for Mental Wellness) for consultation, prescriptions, screening, therapy, etc targeting health condition of concerns. A binary result with either "Yes" or "No" will be recorded.
次要结局
- Rate of medical resource utilization(1- , 6-, 7-, and 12-month after baseline.)
- Characteristics of medical resource utilization(1- , 6-, 7-, and 12-month after baseline.)
- Score of self-reported Health Confidence Scale (HCS)(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Score of self-reported Self-Management Assessment Scale (SMASc)(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Score in HK Chinese version of the EQ-5D-5L instrument (EQ-5D-5L HK) measuring quality of life(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Score in EuroQol Visual Analogue Scale (EQ-VAS) measuring quality of life(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of vasomotor symptoms(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Types of urinary incontinence(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of depression(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of anxiety(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of osteoporosis(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of urinary incontinence(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of breast cancer(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of hypertension(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of cervical cancer(1- , 3-, 6-, 7-, and 12-month after baseline.)
- Risk level of colorectal cancer(1- , 3-, 6-, 7-, and 12-month after baseline.)
研究者
Prof. Sophia Siu-chee Chan
Professor
The University of Hong Kong