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.
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.
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.
- Conditions
- Pharmacist-Patient Relations
- 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 group | Role | What they receive |
|---|---|---|
| the intervention group | Other | this 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 group | No intervention | this 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.
HbA1c
Measured: 3 months
Secondary outcomes (7)
Lipid profile
LDL , HDL , TGS
Measured: 3 months
Fasting blood glucose
Measured: each month for 3 months
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
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
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
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
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.
- First posted8 Sep 2023
- Study start17 Oct 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacist-Patient RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyana Alelaimat, University of Jordan
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06029842
- Acronym / sponsor ID
- Clinical pharmacist
- Conditions
- Pharmacist-Patient Relations
- Keywords
- clinical pharmacist, medical center, Ministry of Health, Collaborative approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic patients outcomes in a primary health care center.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group | Other | Other: Collaborative approach of clinical pharmacist with physicians in a medical centerthis group received the collaborative care between the clinical pharmacist and physicians in a medical center |
| the control group | No intervention | –this group received the standard care of physicians in a medical center without clinical pharmacist interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more at the time of diagnosis
Key exclusion criteria (5 listed)
- pregnant patients
- breastfeeding patients
- patients with urgent or emergent cases
- patients with cognitive impairment
- if the patient is unable to provide informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative approach of clinical pharmacist with physicians in a medical centerFor 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. | Other | the intervention group |
Primary outcome
HbA1c
Time frame: 3 months
7 secondary outcomes
Lipid profile
Time frame: 3 months
Fasting blood glucose
Time frame: each month for 3 months
Patients knowledge about their medications
Time frame: 3 months
Cost avoidance of implemented clinical pharmacist interventions
Time frame: 3 months
Patients adherence to medications
Time frame: 3 months
Quality of life
Time frame: 3 months
Blood pressure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.