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

Nurse-led Medication Self-management Intervention in the Improvement of Medication Adherence in Adult Patients With Multi-morbidity: A Feasibility Randomized Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Diseases; Hypertension; Diabetes; Cancer; Asthma; CKD; Thyroid
• Intervention / Treatment: Behavioral: Motivational tteaching

Detailed Description

In terms of intervention we are giving six weeks motivational training ( 3 face face session and 2 telephonic follow ups).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kalpana Singh, Ph.D; Phone Number: 40258218; Email: nkalpanasingh@gmail.com
• Study Contact Backup: Name: Badriya Lenjawi, Ph.D; Email: blenjawi@hamad.qa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• +18 years old or over,
• Patients with at least two of the identified comorbidities (Hypertension, Chronic painful condition, Cancer, Inflammatory connective tissue disorders, Diabetes, Lipid disorder, Dyspepsia and gastroenteritis, Heart disease, Chronic obstructive pulmonary disease, Stroke and cerebrovascular disease , chronic kidney disorder , Asthma Thyroid disorders, Anemia, Chronic liver disease, Depression, Epilepsy, Anxiety & other stress related disorders), (3) having at least one medication prescribed for a chronic condition over at least the 3 months prior to inclusion in the study,
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational treatment; 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; 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.
No Intervention: Standard Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Knowledge	Change medication knowledge using The Patients' Perceived Knowledge in Medication Use Questionnaire (PKMUQ). The response scale ranges from 1 = strongly disagree to 5 = strongly agree, and the response scores of all 5 items will be summed. Higher scores indicate a higher level of medication knowledge. the score will vary from 5 to 25.	3 months
Medication beliefs	using the Beliefs about Medication Questionnaire (BMQ 18-item)self-reported questionnaire we will assess the medication beliefs from baseline to 3 months. A 5-point Likert scale ranging from 1 = strongly disagree to 5 = strongly agree is used. A higher score indicates stronger beliefs about the corresponding concepts in each subscale. the score range would be 5 to 90.	3 months
Medication self-efficacy	Change in Self efficacy will be assess using the SEAMS 13 items of questionnaire. Each item has a 3-point scale ranging from 1 = not confident to 3 = very confident. The score of scale ranges from 13 to 39, with a higher medication self-efficacy by a higher score.	3 months
Treatment burden	The change in behavior and emotional burden using MTBQ questionnaire. Each item is scored on 6-point Likert scale, ranging from 0 = does not apply to 5 = most difficult. Scores are summed to derive a total score ranging from 0 to 50 with a higher score indicating a higher level of treatment burden.	3 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Collaborators: Medical Research Council

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Research data will be stored on a password-protected computer and backed up on a password-protected hard drive Research Department 322A 3rd floor 302.

PI and Senior Biostatistician will have the access of full data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No