Pharmacist-led Intervention in Treatment Non-adherence in Southwestern Nigeria

NCT04712916 | Completed

• 1 other identifier: UI/EC/14/0294
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

Summary of the Research Medication non-adherence has a huge economic impact on the patient and the society at large. World Health Organization (WHO) has suggested that noncompliance with medication is a common problem which often leads to compromised health benefits and serious economic consequences in terms of wasted time, money and increased morbidity. Other consequences are waste of medication, disease progression, reduced functional abilities, lower quality of life, and increased use of medical resources such as nursing homes, hospital visits and hospital admissions. Non-adherence is common to patients with chronic diseases, such as hypertension and diabetes, compared to patients with acute conditions. The annual cost of medication non-adherence, which includes hospital and nursing home admissions, increased ambulatory costs, lost productivity and premature deaths, has been estimated to be more than $100 billion per year in the United States. In Canada, hospital expenditures caused by non-adherence was estimated to be more than US$1.6 billion. The potential burden of medication non-adherence outcomes on health care delivery makes it an important public health concern. Many studies have addressed non-adherence to medication in developed countries. Past studies on non-adherence in Nigeria have identified different rates of non-adherence to medications for disease states such as diabetes mellitus and hypertension. Literature is scanty on studies on cost of non-adherence in Nigeria. This study will be focus on cost implications of non-adherence to treatment among patients of selected disease states (hypertension and type 2 diabetes mellitus). Research design The study was a quasi-experimental study among T2D patients that were recruited from the two hospitals using questionnaire-guided semi-structured interview. At the baseline, participants with HbA1c ≥7% were classified as uncontrolled/intervention group, while those with HbA1c \<7% were considered as control group. Similarly, participants with blood pressure \<140/90mmHg were classified as control/adherent while those with blood pressure ≥140/900mmHg were uncontrolled/intervention group. Methodology A quasi-experimental study among 201-patients with T2D using semi-structured interview. Baseline questionnaire comprised modified 4-items Medication Adherence Questions (MAQ), Perceived Dietary Adherence Questionnaire (PDAQ) and International Physical Activity Questionnaire, to assess participants' adherence to medications, diet and physical activity, respectively. Patients were assigned into control (HbA1c\<7%, n=95) and intervention (HbA1c≥7%, n=106) groups. Post-baseline, participants were follow-up for 6-months with educational intervention provided to clarify and resolve identified discrepancies among the intervention group only, while the control group continued to receive the usual care. Costs of management including transportation fare, consultation fee, medications and laboratory investigations were estimated for 6-months pre-baseline and 6-months post-baseline for both groups. Data were summarized using descriptive statistics, while Chi-square, McNemar and paired t-test were used for categorical and continuous variables at p\<0.05. Principal exposure: Glycated haemoglobin HbA1c, was measured for Type 2 DM participants and blood pressure was taken for hypertensive participants Outcome variable: Effect of pharmacist-led intervention on therapy non-adherence, reasons for non-adherence and costs of management.

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacoeconomics; diabetes; hypertension; direct cost

Outcome Measures

Primary Outcomes (2)

• Change in the value of Glycosylated haemoglobin (HbA1c)

  Finger pin-prick blood assay of glycosylated haemoglobin (HbA1c) was done using the clover A1C automated analyser ® (PTS Diagnostics, IN, USA) point-of-care kit

  Baseline and 6-month post baseline

• Change in value of blood pressure readings

  Blood Pressure measurements using Omron® digital monitor were taken on two separate occasions at five minutes interval and the average was recorded for each participant

  Baseline and 6-month post baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

Individualized education on medication use, appropriate diet and physical activity was given to the participants in intervention group.

Behavioral: Health education

Control group

NO INTERVENTION

Participant received usual care in the clinic. No individualized education on medication use, appropriate diet and physical activity was given to the participants.

Interventions

Health education BEHAVIORAL

Individualized education intervention on medication use, appropriate diet and physical activity was explained to participants. Participants were guided on achieving recommended metabolic equivalent per week (MET) physical activity considering their health status and daily activities. Furthermore, participants were guided on appropriate dietary recommendation and resolving non-adherence behaviour to medication(s), diet and physical activity.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult out-patients diagnosed and being managed for T2D or hypertension or the co-morbid diseases.
• Participants must have been on antidiabetes/or antihypertensive medication(s) for at least six-months prior to their recruitment to the study.

You may not qualify if:

• Newly diagnosed T2D and hypertensive patients
• Pregnant women with diabetes or hypertension.
• Unconscious patients and those booked for admission.
• Patients less than 18 years of age.

Sponsors & Collaborators

• University of Ibadan: lead

Study Sites (1)

University College Hospital

Ibadan, Oyo State, 234, Nigeria

Location

Related Publications (1)

• Ipingbemi AE, Erhun WO, Adisa R. Pharmacist-led intervention in treatment non-adherence and associated direct costs of management among ambulatory patients with type 2 diabetes in southwestern Nigeria. BMC Health Serv Res. 2021 Sep 22;21(1):1000. doi: 10.1186/s12913-021-06979-z.

  PMID: 34551779 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wilson O Erhun, PhD

  Univeristy of Ibadan, Ibadan, Oyo State, Nigeria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were allocated based on their HbA1c values and blood pressure in to control and intervention groups. Participants were not aware if they were in intervention group or control group as they were not informed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs (A Pharmacist and a PhD student in Department of Clincal Pharmacy and Pharmacy Administration)

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: June 10, 2017
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

NG (1)