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Completed

NCT Number: NCT06029842

The Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients in a Primary Medical Center in Jordan

This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic patients outcomes in a primary health care center.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abu-Nsair medical center

Amman, Jordan

About this study

About 103 patients with type 2 diabetes were randomized to control or intervention group, the control group received a standard care, while the intervention group received the collaborative care between the clinical pharmacist and physicians. Fasting blood glucose, HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three months of follow-up. Treatment related problems (TRPs), quality of life, adherence, and patients knowledge about their medications were assessed. Cost avoidance and clinical significance of implemented clinical pharmacist interventions were assessed too.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more at the time of diagnosis

Exclusion criteria

  • pregnant patients
  • breastfeeding patients
  • patients with urgent or emergent cases
  • patients with cognitive impairment
  • if the patient is unable to provide informed written consent

Treatment and study plan

Collaborative approach of clinical pharmacist with physicians in a medical center

Other

For those who allocated to the intervention group, the clinical pharmacist interviewed them at each monthly visit about 30 minutes before seeing physicians, the clinical pharmacist identified treatment related problems, provided medication counseling, answered questions asked by patients or physicians, encouraged compliance, offered instructions on self-monitoring of blood pressure and glucose levels, distributed educational materials about diabetes and emphasis was made on optimizing adherence to pharmacological and non- pharmacological therapy. the pharmacist interventions on treatment related problems (TRPs) and proposed patient care plans were discussed with treatng physicians who decided to accept or reject them.

Primary outcomes

  1. HbA1c

    Time frame: 3 months

Secondary outcomes

  1. Lipid profile

    Time frame: 3 months

    LDL , HDL , TGS

  2. Fasting blood glucose

    Time frame: each month for 3 months

  3. Patients knowledge about their medications

    Time frame: 3 months

    Validated questionnaire were used. According to Abu Farha et.al, Patients' medication knowledge was assessed by their ability to answer correctly the questions related to their medication doses, indications and timing. For each correct statement the patient gained 1 point with a total of 3 points for each medication. Patients were considered to have suboptimal knowledge if they obtain an average medication score of 2 or less.

  4. Cost avoidance of implemented clinical pharmacist interventions

    Time frame: 3 months

    The cost avoidance of implemented interventions were evaluated relevant to "presumed cost avoidance". This implies an action that reduces or eliminates additional spending that would have happened if the intervention had not occurred. The reduction in costs was estimated using the cost avoidance values that were derived from Campbell. The resulting cost avoidance values for individual clinical pharmacy intervention types are listed below for individual clinical pharmacy intervention type.* Intervention type, Overall cost avoidance, $ Addition of a medication 62.81

    • Change medication 74.67
    • Discontinuation of a medication 57.25
    • Dosage form change 67.33
    • Dose adjustment 71.41
    • Drug information 26.97
    • Medication reconciliation 472.86
    • Monitoring laboratory order 93.58
    • Non-formulary consultation 56
    • Non-formulary to formulary conversion 44
    • Pharmacokinetic monitoring-level adjustment 91.08
    • Prevention of adverse drug event 581.08
    • Prompted medical follow-up 70.33
  5. Patients adherence to medications

    Time frame: 3 months

    Patients' adherence to medications was assessed by Oriana Awwad et al.2022 validated Arabic version of the Morisky, Green, and Levine (MGL) adherence scale [16], This scale is "a 4-item instrument used to identify patients with chronic disease who are not taking their medications as prescribed". The scale encloses four questions: 1) "Do you ever forget to take your medicine?" 2) "Are you careless at times about taking your medicine?" 3) "When you feel better do you sometimes stop taking your medicine?" and 4) "Sometimes if you feel worse when you take the medicine, do you stop taking it?" It has a scoring scheme of "Yes" = 1 and "No" = 0 for each item with a total score ranging from 0 to 4. The sum of "Yes" answers provides a composite measure of non-adherence. Lower evaluations imply a higher level of adherence, and total patient scores can be classified into high adherence level (0 answered "yes"), moderate adherence level (1-2 answered "yes") and low level adherence (3-4 "yes").

  6. Quality of life

    Time frame: 3 months

    The change in the Quality of Life questionnaire (EQ-5D-5L) was assessed. At baseline, all patients were asked to self-complete the Quality of Life (EQ-5D-5L) questionnaire. This self-completed questionnaire consists of 5 domains" (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)" in which each dimension is rated with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems). The answers on these domains are translated to give a consequent number; e.g 23445. These numbers have a health utility index score which already had been studied and validated for different population in a number of countries. A single index value for all health states with a range from 0 (where zero is a health state equivalent to death). Another factor express QoL is EQ-vas which is a scale from 0 to 100 where the patients are asked to indicate their overall health on the day after completion of questionnair.

  7. Blood pressure

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

A Randomized Controlled Trial to Assess the Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients for Optimum Treatment Outcomes in a Primary Medical Center in Jordan

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2023
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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