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Pharmacist-Patient RelationsNCT06029842

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

A study testing Collaborative approach of clinical pharmacist with physicians in a medical center in people with Pharmacist-Patient Relations, run by University of Jordan at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmacist-Patient Relations
What is being tested?
Collaborative approach of clinical pharmacist with physicians in a medical center
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteJordan
Study dates
17 Oct 2022to 24 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • Abu-Nsair medical center

    Amman

Other trials in Jordan

About this study

Official 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

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

Read the detailed description

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.

Being tested
Collaborative approach of clinical pharmacist with physicians in a medical center
Keywords
clinical pharmacist, medical center, Ministry of Health, Collaborative approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collaborative approach of clinical pharmacist with physicians in a medical centerOther

    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.

Study groups in NCT06029842
Study groupRoleWhat they receive
the intervention groupOtherthis group received the collaborative care between the clinical pharmacist and physicians in a medical center
Receives: Other: Collaborative approach of clinical pharmacist with physicians in a medical center
the control groupNo interventionthis group received the standard care of physicians in a medical center without clinical pharmacist interventions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: 3 months

Secondary outcomes (7)
  1. Lipid profile

    LDL , HDL , TGS

    Measured: 3 months

  2. Fasting blood glucose

    Measured: each month for 3 months

  3. Patients knowledge about their medications

    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.

    Measured: 3 months

  4. Cost avoidance of implemented clinical pharmacist interventions

    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

    Measured: 3 months

  5. Patients adherence to medications

    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").

    Measured: 3 months

  6. Quality of life

    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.

    Measured: 3 months

  7. Blood pressure

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start17 Oct 2022
  3. Primary completion24 Apr 2023
  4. Study completion24 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029842
Sponsor's protocol ID
Clinical pharmacist
Status last verified
Oct 2024
First submitted
1 Sep 2023
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Collaborative approach of clinical pharmacist with physicians in a medical center in people with Pharmacist-Patient Relations, run by University of Jordan at 1 site in Jordan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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