Trial Title:
Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong
NCT ID:
NCT06628388
Condition:
Vasomotor Symptoms
Urinary Incontinence
Anxiety
Depression - Major Depressive Disorder
Osteoporosis
Breast Cancer
Hypertension
Cervical Cancers
Colorectal Cancer
Conditions: Official terms:
Osteoporosis
Urinary Incontinence
Depressive Disorder
Depressive Disorder, Major
Conditions: Keywords:
nurse-led
women health
risk-based
primary healthcare
5As model
stepped-wedge
cluster RCT
health resource utilization
self-management
risk stratification
health screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
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
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Nurse-Led Risk-Based 5As Primary Healthcare Model
Description:
The intervention is developed based on the 5As model (ask, advice, assess, assist,
arrange). In this model, nurse will play the central role in delivering the service as a
case manager. In Ask, all participants will be assessed on the demographics, health
related status, and health risk stratification (i.e. 3-tier risk stratification). In
Advice, all participants will be given the education booklet. Those assessed to be at low
risks will receive general advice, while those at medium risk will receive
condition-specific advice instead. High risk participants will be provided with referral
suggestions. The assessment of medium or high risk participants willingness and any
barriers in seeking changes will be conducted in Assess. In Assist, active referrals will
be provided to high risk participants, with weekly advice messages provided to medium and
high risk participants. In Arrange, all participants will receive their follow-ups.
Arm group label:
Nurse-led Risk-based 5As Intervention Arm
Intervention type:
Behavioral
Intervention name:
Minimal Intervention
Description:
Consisting general advice on women health with the education booklet. No risk-based
services nor active referral will be offered during the waitlist control exposure.
Participants will be switched to receive intervention from 6-month.
Arm group label:
Waitlist Control Arm
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.
Criteria for 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.
Gender:
Female
Minimum age:
45 Years
Maximum age:
64 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
November 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
The Hong Kong Jockey Club Charities Trust
Agency class:
Other
Collaborator:
Agency:
Haven of Hope Hospital
Agency class:
Other
Collaborator:
Agency:
Hong Kong Sheng Kung Hui Welfare Council Limited
Agency class:
Other
Collaborator:
Agency:
Aberdeen Kai-fong Welfare Association
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06628388
