Diabetes Mellitus, Type 2NCT03531944
Impact of Community Pharmacist-Involved Collaborative Care Model for the Management of Type 2 Diabetes Mellitus
A study testing Community pharmacist-involved collaborative care in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.
Trial summary
Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014 and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of diabetes management, collaborative efforts by nurses and other allied health professionals such as dietitians and pharmacists have shown… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Community pharmacist-involved collaborative care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 265 participants
- Where
- 1 siteSingapore
- Study dates
- 6 Jun 2018to 31 Mar 2020
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All individuals aged 21 years and above, diagnosed with type 2 diabetes mellitus with a baseline HbA1c of more than 7.0% and taking 5 or more chronic medications
Who cannot join
- Individuals with type 1 diabetes mellitus
- Mentally incapacitated individuals
- Individuals who are illiterate and unable to communicate in English, Malay, or Chinese (Mandarin)
- Individuals who are not able to complete the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Community Pharmacist-Involved Collaborative Care in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore (IMPACT-C)
Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014 and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of diabetes management, collaborative efforts by nurses and other allied health professionals such as dietitians and pharmacists have shown to play a significant role in improving clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the collaborative care model has only been evaluated prospectively in the primary and tertiary care settings involving clinical pharmacists. The impact of the unique, synergistic roles of community pharmacists with family physician on the clinical, humanistic and economic outcomes have yet to be elucidated.
Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a community pharmacist-involved collaborative care model in the management of individuals with type 2 diabetes mellitus.
Read more
Hypothesis: Incorporating community pharmacist into the care model with family physician and nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2 diabetes mellitus.
Methods: This study is a prospective, open label, parallel arm, randomized controlled trial. The study will be conducted over 6 months at a family medicine clinic in Singapore. Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking 5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are unable to communicate independently in English, Mandarin or Malay will be excluded from this study. The participants will be randomly assigned to 2 groups using a random number generator or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with physician and community pharmacist (intervention). The community pharmacist will adopt the core elements of the medication therapy management model in reviewing the medications of participants as well as provide relevant lifestyle counselling and health education via a face-to-face consultation at the clinic and subsequently through telephonic correspondences. The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood pressure, lipid markers, distress level, self-care capabilities, quality of life, productivity, and direct medical costs.
Significance: The outcomes of the community pharmacist-involved collaborative care model will support future implementation and integration of this care model into the standard of care in Singapore so as to optimize the management of type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Community pharmacist-involved collaborative care, Usual care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community pharmacist-involved collaborative careOther
Community pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus
Usual careOther
Usual care with physician and as needed visit to the nurse
| Study group | Role | What they receive |
|---|---|---|
| Community pharmacist-involved care | Experimental | Community pharmacist-involved collaborative care in the management of type 2 diabetes mellitus Receives: Other: Community pharmacist-involved collaborative care |
| Usual care | Placebo comparator | Usual care with physician and as needed referral to nurses Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c level
Change in HbA1c level over 6 months
Measured: Baseline and 6 months
Secondary outcomes (9)
Change in blood pressure
Change in systolic blood pressure and diastolic blood pressure
Measured: Baseline and 6 months
Change in lipid markers
Change in total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglyceride levels
Measured: Baseline and 6 months
Change in diabetes-related distress
Measured by 20-item Problem Areas in Diabetes (PAID), with each item scoring from 0 to 4. The total score is computed by the sum of score of each item, ranging from 0 to 100 (highest distress level).
Measured: Baseline and 6 months
Change in general health status
Measured by EuroQoL 5-Dimension 5-Level (EQ-5D-5L), each item scored individually on a scale of 1 to 5 (1 being least problem and 5 being most problem). EQ-5D-5L comes with a visual analogue scale assessing general health-related quality of life on that day, ranging from 0 (worst health imaginable) to 100 (best health imaginable).
Measured: Baseline and 6 months
Change in diabetes-specific quality of life
Measured by the 21-item Audit of Diabetes-Dependent Quality of Life (ADDQoL), with 2 global general quality of life questions and 19 domains with weighted score between impact and importance. The average weighted impact is the average of the impact of all domains (ranging from -9, being worst quality of life to +3, being best quality of life).
Measured: Baseline and 6 months
Change in general work productivity
Measured by 6-item Work Productivity Activity Impairment-Global Health (WPAI-GH), four primary outcomes based on the questions including:
Per cent of work time missed due to health conditions (absenteeism): Q2/(Q2+Q4).
Per cent impairment while working due to health conditions (presenteeism): Q5/10.
Per cent overall work impairment due to health: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))×(Q5/10)].
Per cent impairment in activities due to health: Q6/10.
Measured: Baseline and 6 months
Change in self efficacy and self-care capabilities
Measured by Summary of Diabetes Self-Care Activities scale (SDSCA),comprised of items assessing five domains of diabetes self-management which are "general diet (2 items), specific diet (2 items), exercise (2 items), blood glucose testing (2 items) and foot care (2 items) and the medication self-management component and smoking self-management component. Each item will be reported as a mean across the sample and analysed individually.
Measured: Baseline and 6 months
Incidence of hypoglycemia
Incidence of hypoglycemia over 6 months
Measured: Baseline and 6 months
Cost effectiveness analysis
Cost effectiveness of the community pharmacist-involved collaborative care model
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start6 Jun 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joyce Lee, PharmD, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531944
- Sponsor's protocol ID
- H-18-019
- Status last verified
- Mar 2021
- First submitted
- 9 May 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lum ZK, Tan JY, Wong CSM, Kok ZY, Kwek SC, Tsou KYK, Gallagher PJ, Lee JY. Reducing economic burden through split-shared care model for people living with uncontrolled type 2 diabetes and polypharmacy: a multi-center randomized controlled trial. BMC Health Serv Res. 2024 Jun 22;24(1):760. doi: 10.1186/s12913-024-11199-2.
PubMed 38907254
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Community Pharmacist-Involved Collaborative Care in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore (IMPACT-C)
- ClinicalTrials.gov ID
- NCT03531944
- Acronym / sponsor ID
- H-18-019
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 May 2018 (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.
Background: In Singapore, the prevalence of diabetes mellitus was approximately 12.8% in 2014 and the prevalence was projected to rise to 22.7% in 2035. In view of the complexity of diabetes management, collaborative efforts by nurses and other allied health professionals such as dietitians and pharmacists have shown to play a significant role in improving clinical care of individuals with diabetes. Currently in Singapore, the effectiveness of the collaborative care model has only been evaluated prospectively in the primary and tertiary care settings involving clinical pharmacists. The impact of the unique, synergistic roles of community pharmacists with family physician on the clinical, humanistic and economic outcomes have yet to be elucidated.
Aims: This study aims to evaluate the clinical, humanistic, and economic outcomes of a community pharmacist-involved collaborative care model in the management of individuals with type 2 diabetes mellitus.
Hypothesis: Incorporating community pharmacist into the care model with family physician and nurse can improve the clinical, humanistic, and economic outcomes of individuals with type 2 diabetes mellitus.
Methods: This study is a prospective, open label, parallel arm, randomized controlled trial. The study will be conducted over 6 months at a family medicine clinic in Singapore. Individuals aged 21 years and above, diagnosed with type 2 diabetes (HbA1c > 7.0%) and taking 5 or more chronic medications will be eligible. Individuals with Type 1 diabetes or who are unable to communicate independently in English, Mandarin or Malay will be excluded from this study. The participants will be randomly assigned to 2 groups using a random number generator or an equivalent: (1) Usual diabetes care with physician (control), (2) diabetes care with physician and community pharmacist (intervention). The community pharmacist will adopt the core elements of the medication therapy management model in reviewing the medications of participants as well as provide relevant lifestyle counselling and health education via a face-to-face consultation at the clinic and subsequently through telephonic correspondences. The primary outcome will be change in HbA1c over 6 months. Secondary outcomes include blood pressure, lipid markers, distress level, self-care capabilities, quality of life, productivity, and direct medical costs.
Significance: The outcomes of the community pharmacist-involved collaborative care model will support future implementation and integration of this care model into the standard of care in Singapore so as to optimize the management of type 2 diabetes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community pharmacist-involved care | Experimental | Other: Community pharmacist-involved collaborative careCommunity pharmacist-involved collaborative care in the management of type 2 diabetes mellitus |
| Usual care | Placebo comparator | Other: Usual careUsual care with physician and as needed referral to nurses |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals aged 21 years and above, diagnosed with type 2 diabetes mellitus with a baseline HbA1c of more than 7.0% and taking 5 or more chronic medications
Key exclusion criteria (4 listed)
- Individuals with type 1 diabetes mellitus
- Mentally incapacitated individuals
- Individuals who are illiterate and unable to communicate in English, Malay, or Chinese (Mandarin)
- Individuals who are not able to complete the questionnaires
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 |
|---|---|---|
| Community pharmacist-involved collaborative careCommunity pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus | Other | Community pharmacist-involved care |
| Usual careUsual care with physician and as needed visit to the nurse | Other | Usual care |
Primary outcome
Change in HbA1c level
Time frame: Baseline and 6 months
Change in HbA1c level over 6 months
9 secondary outcomes
Change in blood pressure
Time frame: Baseline and 6 months
Change in lipid markers
Time frame: Baseline and 6 months
Change in diabetes-related distress
Time frame: Baseline and 6 months
Change in general health status
Time frame: Baseline and 6 months
Change in diabetes-specific quality of life
Time frame: Baseline and 6 months
Change in general work productivity
Time frame: Baseline and 6 months
Change in self efficacy and self-care capabilities
Time frame: Baseline and 6 months
Incidence of hypoglycemia
Time frame: Baseline and 6 months
Cost effectiveness analysis
Time frame: 6 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 2 Mar 2021.
- Derived from this study: PubMed 38907254Lum ZK, Tan JY, Wong CSM, Kok ZY, Kwek SC, Tsou KYK, Gallagher PJ, Lee JY. Reducing economic burden through split-shared care model for people living with uncontrolled type 2 diabetes and polypharmacy: a multi-center randomized controlled trial. BMC Health Serv Res. 2024 Jun 22;24(1):760. doi: 10.1186/s12913-024-11199-2.
- Individual participant dataSharing planned: No
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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 Community pharmacist-involved collaborative care in people with Diabetes Mellitus, Type 2, run by National University of Singapore at 1 site in Singapore.
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 4 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 2 Mar 2021. 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 Singapore. 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. Some participants in this study may receive a placebo. 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?
Change in HbA1c level (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03531944, which also lists 1 linked publication.
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 2 Mar 2021.