Tokyo, March 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061033) titled 'Verification of the Effectiveness of Nursing Interventions Using the "System for Nurses to Support Medication Adherence in Older Adults" Through a Non-Randomized Controlled Trial' on March 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - SHIMANE University
Condition:
Condition - Older adults with various chronic diseases (not limited to a specific disease)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to evaluate the effectiveness of a nursing intervention using the "Nursing Support System for Medication Adherence in Older Adults" for elderly patients admitted to community-based integrated care wards, from the perspective of improving medication adherence.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - In the intervention group, nurses use the "Nursing Support System for Medication Adherence in Older Adults" to perform an initial assessment within 3 days of admission. Based on the system's radar chart, nurses identify strengths and weaknesses in patients' medication self-management, provide individualized counseling, explain medication management strategies, offer motivational support, and, if necessary, provide guidance to family members. Reassessments and adjustments to the nursing plan are conducted regularly throughout the intervention period (2-8 weeks during hospitalization).
Interventions/Control_2 - In the control group, the "Nursing Support System for Medication Adherence in Older Adults" will not be used, and usual nursing support for medication adherence will be provided.
Eligibility:
Age-lower limit - 65
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients admitted to community-based integrated care wards at a Hospital
2. Aged 65-74 years and under the care of the participating nurse
3. Expected hospital stay >=2 weeks
4. Continuously taking cardiovascular medications
5. Self-managing >=3 medications with family support
6. Able to provide written informed consent
7. Approved for participation by the attending physician
Key exclusion criteria - 1. Severe hearing or language impairments preventing understanding of the study or providing consent
2. Severe physical illness or acute exacerbation making the intervention difficult, or life expectancy judged to be extremely short
3. Diagnosis of dementia or MCI, or cognitive impairment leading to family- or healthcare provider-led medication management
4. History of psychiatric disorders or current pharmacotherapy for psychiatric conditions
5. Hospital stay <2 weeks, making intervention or evaluation insufficient
6. Complete discontinuation of all oral medications during the intervention period or after discharge
Target Size - 34
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 11 Month 13 Day
Date of IRB - 2025 Year 10 Month 20 Day
Anticipated trial start date - 2026 Year 01 Month 23 Day
Last follow-up date - 2026 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068336
Disclaimer: Curated by HT Syndication.
