Clinical trial · Interventional
Nurse-led Primary Healthcare Intervention Model in Women's Health Management in Hong Kong
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Depression - Major Depressive Disorder | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Osteoporosis | — | UNRESOLVED | — |
| Urinary Incontinence | — | UNRESOLVED | — |
| Vasomotor Symptoms | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Minimal Intervention | Behavioral | — | UNRESOLVED |
| Nurse-Led Risk-Based 5As Primary Healthcare Model | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Minimal intervention
- description
- 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.
- interventionNames
- Behavioral: Minimal Intervention
- type
- EXPERIMENTAL
- label
- Nurse-led Risk-based 5As Intervention Arm
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDNasreen SZA: Management of Menopause: Jaypee Brothers Medical Publishers; 2021.
- BACKGROUNDSaitz 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
- BACKGROUNDSlev 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
- BACKGROUNDKolac 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
- BACKGROUNDWang 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
- BACKGROUNDLi 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
- BACKGROUNDChłoń-Domińczak A, Kotowska IE, Kurkiewicz J, Abramowska-Kmon A, Stonawski M: Population ageing in Europe: facts, implications and policies. Brussels: European Commission 2014