Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong

NCT06628388 | Active Not Recruiting

• 1 other identifier: UW 24-501
• Study Type: interventional
• Target: 1,728
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• Rate of medical resource utilization

  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.

  3-month from baseline

Secondary Outcomes (16)

• 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.

Study Arms (2)

Minimal intervention

ACTIVE COMPARATOR

Participants allocated to the control group condition will be given minimal intervention in standard practices at baseline and 3-month. It consist of general health education and advice, where the health information is open resources available for the public. No risk-stratified services nor active referral will be conducted by nurse until 6-month assessment is completed. After that, they will immediately receive intervention based on their 6-month assessment, and booster interventions at 7-month contact and 12-month follow-up.

Behavioral: Minimal Intervention

Nurse-led Risk-based 5As Intervention Arm

EXPERIMENTAL

Participants allocated to the intervention condition will receive the nurse-led 5As model intervention at baseline, 1- and 3-month boosters, and 6- and 12-month follow-ups. The current model includes risk assessments and stratification, general health education booklet, consultations and active referrals based on personal risk stratification at baseline and 3-month booster, with additional booster session at 1-month, and follow-up sessions at 6- and 12-month from baseline. For participants with high risk of any target health conditions at baseline and 3-month booster, medical referral and service utilization (e.g., GPs/network doctors/specialist consultation at health centres/hospitals/clinics, screening, therapies, corresponding District Health Centre schemes, etc.) will be arranged at the visits. Such medical resource utilization among participants will be encouraged and motivated at 1-month booster session.

Behavioral: Nurse-Led Risk-Based 5As Primary Healthcare Model

Interventions

Nurse-Led Risk-Based 5As Primary Healthcare Model BEHAVIORAL

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.

Nurse-led Risk-based 5As Intervention Arm

Minimal Intervention BEHAVIORAL

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.

Minimal intervention

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• The Hong Kong Jockey Club Charities Trust: collaborator
• Hong Kong Sheng Kung Hui Welfare Council Limited: collaborator
• Aberdeen Kai-fong Welfare Association: collaborator
• Haven of Hope Hospital: collaborator

Study Sites (3)

Aberdeen Kaifong Welfare Association

Hong Kong, HONG KONG, 999077, Hong Kong

Location

Haven of Hope Christian Service

Hong Kong, HONG KONG, 999077, Hong Kong

Location

Hong Kong Sheng Kung Hui Welfare Council

Hong Kong, HONG KONG, 999077, Hong Kong

Location

Related Publications (8)

• Nasreen SZA: Management of Menopause: Jaypee Brothers Medical Publishers; 2021.

  BACKGROUND

• Saitz R, Alford DP, Bernstein J, Cheng DM, Samet J, Palfai T. Screening and brief intervention for unhealthy drug use in primary care settings: randomized clinical trials are needed. J Addict Med. 2010 Sep;4(3):123-30. doi: 10.1097/ADM.0b013e3181db6b67.

  PMID: 20936079 BACKGROUND

• Slev VN, Molenkamp CM, Eeltink CM, Roeline W Pasman H, Verdonck-de Leeuw IM, Francke AL, van Uden-Kraan CF. A nurse-led self-management support intervention for patients and informal caregivers facing incurable cancer: A feasibility study from the perspective of nurses. Eur J Oncol Nurs. 2020 Apr;45:101716. doi: 10.1016/j.ejon.2019.101716. Epub 2020 Jan 20.

  PMID: 32023503 BACKGROUND

• Kolac N, Yildiz A. The effect of health belief model-based short interviews in women in the postmenopausal period on the prevention of osteoporosis: A randomized controlled trial. Int J Nurs Pract. 2023 Feb;29(1):e13121. doi: 10.1111/ijn.13121. Epub 2022 Dec 16.

  PMID: 36524466 BACKGROUND

• Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.

  PMID: 33323188 BACKGROUND

• Li C, Liu Y, Xue D, Chan CWH. Effects of nurse-led interventions on early detection of cancer: A systematic review and meta-analysis. Int J Nurs Stud. 2020 Oct;110:103684. doi: 10.1016/j.ijnurstu.2020.103684. Epub 2020 Jun 12.

  PMID: 32702568 BACKGROUND

• Chłoń-Domińczak A, Kotowska IE, Kurkiewicz J, Abramowska-Kmon A, Stonawski M: Population ageing in Europe: facts, implications and policies. Brussels: European Commission 2014

  BACKGROUND

• United Nations. World Population Ageing 2017 Highlights (ST/ESA/SER.A/397). Population Division World Population Ageing. 2017.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Anxiety Disorders; Osteoporosis; Breast Neoplasms; Hypertension; Uterine Cervical Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vascular Diseases; Cardiovascular Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Siu Chee Chan, Professor

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 8, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): February 26, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

HK (3)