Clinical trial NCT06628388: Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong
Official title: Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vasomotor Symptoms
Urinary Incontinence
Anxiety
Depression - Major Depressive Disorder
Osteoporosis
Breast Cancer
Hypertension
Cervical Cancers
Colorectal Cancer
Keywords: nurse-led
women health
risk-based
primary healthcare
5As model
stepped-wedge
cluster RCT
health resource utilization
self-management
risk stratification
health screening
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Hong Kong Jockey Club Charities Trust
name: Haven of Hope Hospital
name: Hong Kong Sheng Kung Hui Welfare Council Limited
name: Aberdeen Kai-fong Welfare Association
First posted: 2024-10-08
Enrollment: 1728
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A stepped-wedge cluster randomized waitlist-controlled trial will be conducted. Stepped-wedge design is considered as a unidirectional crossover RCT. Current trial will consist of four consecutive phases with each lasting for four months. The three social service organizations will be the three clusters to be randomized. In the first phase, all participants in all three clusters will be allocated to the waitlist-control treatment. In the second phase, newly joined participants in cluster 1, randomly determined, will be exposed to the intervention condition, while the other two clusters remain in the waitlist-control. In the third phase, newly joined participants in cluster 1 and 2, will be allocated to the intervention condition, while cluster 3 remain receiving the waitlist-control condition. In the fourth phase, all newly recruited participants in the three clusters will be allocated to intervention condition.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Study Design:

A stepped-wedge cluster randomized waitlist-controlled trial (SWT) will be conducted. The study period will consist of four consecutive phases with each lasting for four months. The three social service organizations will be the three clusters to be randomized. In the first phase, all participants in all three clusters will be allocated to the waitlist-control treatment. In the second phase, newly joined participants in cluster 1, randomly determined, will be exposed to the intervention condition, while the other two clusters remain in the waitlist-control. In the third phase, newly joined participants in cluster 1 and 2, will be allocated to the intervention condition, while cluster 3 remain receiving the waitlist-control condition. In the fourth phase, all newly recruited participants in the three clusters will be allocated to intervention condition. At 6-month follow-up, the waitlist-control participants will be given the same treatment as in intervention condition. A web-based portal system will be created for nurses to facilitate better case management and client coordination.

Procedures:

The NGO staff will receive two day training on clinical knowledge, health condition specific advice and appropriate community medical resources, behavioral modification skills, and study workflow. Booster training the study flow, risk assessment, and use of the web-based portal system will be provided during transition period. Service units of the three non-governmental organizations (NGOs) in the three districts (Aberdeen Kai Fong Association in Southern District (AKA), Haven of Hope Christian Services in Sai Kung District (HOHCS), and Hong Kong Sheng Kung Hui Welfare Council Limited in Wong Tai Sin District (SKHWC)) will screen and recruit appropriate participants for this trial. Recruitment ads will be posted onto offline (e.g., on-site posters) and online platforms (e.g., Facebook and Instagram). Women aged between 45 and 64 will be continuously recruited in the 4 recruitment phases. Participants would include but not limited to those who that are regular attendees (e.g., members) of the three social service organizations, and those in the general population who are seeking primary healthcare services through various offline/online recruitment approaches. Participants will undergo eligibility screening following registration. Eligible participants with consents will be enrolled in the current stepped-wedge waitlist-control randomized trial. For participants who do not meet the eligibility criteria for the current trial but express their willingness in receiving primary healthcare services, such rights will be protected and healthcare services/resources in need will be provided.

Eligibility criteria: Inclusion Criteria:

1. Hong Kong female residents aged 45 to 64 years old; and
2. Able to read and communicate in Chinese (either Cantonese or Mandarin).

Exclusion Criteria:

1. 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;
2. Diagnosed with psychiatric or psychological disorders (e.g., panic disorder, psychosis);
3. Currently taking medication(s) or receiving treatment(s) for psychiatric and psychological disorders;
4. Pregnant or in lactation period, or have plans for pregnancy within 1 year; or
5. Have moderate or severe cognitive impairment.

Primary outcomes:
measure: Rate of medical resource utilization
timeFrame: 3-month from baseline
Secondary outcomes:
measure: Rate of medical resource utilization
timeFrame: 1- , 6-, 7-, and 12-month after baseline.
measure: Characteristics of medical resource utilization
timeFrame: 1- , 6-, 7-, and 12-month after baseline.
measure: Score of self-reported Health Confidence Scale (HCS)
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Score of self-reported Self-Management Assessment Scale (SMASc)
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Score in HK Chinese version of the EQ-5D-5L instrument (EQ-5D-5L HK) measuring quality of life
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Score in EuroQol Visual Analogue Scale (EQ-VAS) measuring quality of life
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of vasomotor symptoms
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Types of urinary incontinence
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of urinary incontinence
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of depression
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of anxiety
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of osteoporosis
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of breast cancer
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of hypertension
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of cervical cancer
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
measure: Risk level of colorectal cancer
timeFrame: 1- , 3-, 6-, 7-, and 12-month after baseline.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Aberdeen Kaifong Welfare Association
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Christian Service
city: Hong Kong
country: Hong Kong
facility: Hong Kong Sheng Kung Hui Welfare Council
Study officials:
affiliation: The University of Hong Kong
name: Siu Chee Chan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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