Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628388
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Nurse-led Primary Healthcare Intervention Model in Womens Health Management in Hong Kong
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nurse-led Primary Healthcare Intervention Model in Womens Health Management in Hong Kong
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JCDATAZONEWH
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
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 womens 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 womens 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 womens 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 eg on-site posters and online platforms eg 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 eg members of the three social service organizations and those in the general population who are seeking primary healthcare services through various offlineonline 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 servicesresources in need will be provided
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 womens 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 womens 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 womens 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 eg on-site posters and online platforms eg 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 eg members of the three social service organizations and those in the general population who are seeking primary healthcare services through various offlineonline 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 servicesresources in need will be provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None