Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence

NCT05645653 | Unknown

• 1 other identifier: 296
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Back ground \& Aims Adult patients suffering from multimorbidity are at high risk of medication non-adherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in Adult patients with multimorbidity. The aim of this study to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes in adult patients with multimorbidity. Methods This study is a single centre, single-blind, two-arm randomised controlled trial. Adult patients with multi-morbidity will be recruited from NCCCR Qatar. A total of 100 participants will be randomly allocated to receive standard care or standard care plus the medication self-management intervention. The intervention will be delivered by clinical nurse specialists. The 6-week intervention includes three face-to-face education sessions (2st week, 4rd week and 6th week) and two weekly (8th week and 10 week) follow-up phone calls. Participants in the control group continue to receive all respects of standard care offered by healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients' diseases and treatments during centre visits. Outcome The primary outcome is medication adherence as measured by the 8-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden). All outcomes will be measured at baseline, immediately post-intervention (7th week), and at 3-month post-intervention.

Conditions

Heart Diseases; CKD; Diabetes; Cancer; Asthma; Thyroid; Hypertension

Outcome Measures

Primary Outcomes (1)

• Medication Adherence

  The Morisky-8 is a self-reporting measure of unintentional and intentional medication non-adherent behaviors with a yes and no response. The total score of the moresky-8 ranges from 0 to 8, with a higher score representing higher adherence to medication. Approx 50% percentage change in medication adherence after intervention from baseline to 3 months as compared to control

  3 months

Secondary Outcomes (4)

• Medication Knowledge

  3 months

• Medication beliefs

  3 months

• Medication self-efficacy

  3 months

• Treatment burden

  3 months

Study Arms (2)

Educational treatment

EXPERIMENTAL

The medication self-management intervention consists of three face-to-face education sessions and two weekly telephone follow-up over 6 weeks. Intervention components are derived from an extensive review of the literature, including the related theoretical framework and current practice. Based on the extended IMB model of medication adherence, this intervention is designed to offer information related to medication treatment, motivate patients to adhere, help build medication self-management skills, and develop adherence improvement plans. The face-to-face meeting will take place in the clinical nurse specialist counselling room in NCCCR.

Behavioral: Motivational tteaching

Standard Care

NO INTERVENTION

Participants in the control group will continue to receive standard care from Physicians, nurses, and clinical pharmacists in the NCCCR. Physicians are the primary providers and coordinators of care for patients with chronic conditions. Physicians provide patients consultations and education regarding their diseases and treatments (typically clinician-centred) at each patient visit to the chronic disease clinic.

Interventions

Motivational tteaching BEHAVIORAL

A comprehensive assessment of adherence problems will be firstly conducted to identify the factors that affect adherence, including how and why these factors contribute to poor adherence. Medication-related knowledge and skills will be provided based on individual treatments and barriers to adherence. Motivational interviewing techniques will be used for a better understanding of patients' cognitive factors of adherence behavior.

Educational treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +18 years old or over,
• Non-adherence to medications, as defined by scoring zero on the 8-item Medication Adherence Report Scale (Morisky -8)(29),
• Independently managing their medications (i.e., not rely on a care taker),
• Able to speak or understand English/Arabic,
• Able and willing to receive phone calls, and
• Capable of providing a written informed consent to participate in the study.

You may not qualify if:

• Being institutionalized in a long-term care facility,
• Planning to move away from the community in the next 6 months,
• Cognitive impairment (Mini-cog scores \< 4), and
• Currently participating in research involving chronic disease management. Patients with cognitive impairment are excluded because they may not be able to provide valid answers to the questionnaires.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Medical Research Council: collaborator

Related Publications (1)

• Singh K, Joy GV, Al Bulushi A, Alomari AMA, Mannethodi K, Kunjavara J, Hassan N, Idris Z, Yassin MADM, Al Lenjawi B. Nurse-led medication self-management intervention in the improvement of medication adherence in adult patients with multi-morbidity: A Protocol for a Feasibility Randomized controlled trial. Glob Epidemiol. 2025 Jan 9;9:100184. doi: 10.1016/j.gloepi.2025.100184. eCollection 2025 Jun.

  PMID: 39897388 DERIVED

MeSH Terms

Conditions

Heart Diseases; Diabetes Mellitus; Neoplasms; Asthma; Thyroid Diseases; Hypertension

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vascular Diseases

Central Study Contacts

Kalpana Singh, Ph.D

CONTACT

40258218; nkalpanasingh@gmail.com

Badriya Lenjawi, Ph.D

CONTACT

blenjawi@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior epidemiologist

Model Details: This is a single Centre open label, two-arm randomized controlled trial with 1:1 randomization at the participant level. The patient population will be patients with at least two comorbidities. The patient recruitment will be done in the National Centre for Cancer Care and Research (NCCCR) in the outpatient department in the clinical nurse specialist counselling room.

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 9, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share