Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/11/2015
Date assigned
06/11/2015
Last edited
06/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetes is one of the common chronic health problems that affects many people in Singapore. Uncontrolled diabetes, where patients have persistently high levels of sugar in the blood, can harm important organs such as heart and the kidneys, and the management of diabetes-related complications is costly. People with diabetes, however, can still live a long and healthy life if their diabetes is well-controlled. Well-controlled diabetes requires healthy diet and active lifestyle, and optimal use of medications is also essential in ensuring timely control of diabetes. The purpose of this study is to find out the value of a new care approach which involves pharmacists, in addition to nurses, dieticians and other healthcare professionals, to support physicians in caring for patients with uncontrolled diabetes.

Who can participate?
Patients aged at least 21 years with uncontrolled type 2 diabetes, and other uncontrolled co-morbidities (other health conditions).

What does the study involve?
Patients are randomly allocated to one of two groups. Those in group 1 receive the active involvement of the pharmacist in drug optimization. Referrals to nurses and dieticians are actively made by the pharmacist and vice versa as required. Patients in group 2 (the control group) receive their usual or conventional care from the physician with as needed referral at the discretion of the physician to the nurses and dieticians. These patients are seen by different physicians at each visit, and pharmacists are not involved in drug optimization except for dispensing.

What are the possible benefits and risks of participating?
Patients who participate in this study may reasonably expect to benefit from the pharmacist-involved healthcare model in that the pharmacists will be able to assist patients in reviewing and explaining their blood glucose results, optimize medications, provide a cost-effective medication regimen, assist in setting goals to improve patients' conditions, answer questions related to medications and empower patients' knowledge on medications. There will not be any possible risks or side effects for participating in this study. Because the involvement of pharmacist is to provide an added value, patients' standard of care or routine care is still being preserved.

Where is the study run from?
National Healthcare Group Health Institutions (Singapore)

When is study starting and how long is it expected to run for?
December 2012 to November 2015

Who is funding the study?
Singapore Ministry of Health

Who is the main contact?
Professor Joyce Lee
phalycj@nus.edu.sg

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joyce Lee

ORCID ID

http://orcid.org/0000-0003-2620-555X

Contact details

Department of Pharmacy
Faculty of Science
National University of Singapore
Block S4
18 Science Drive 4
Singapore
117543
Singapore
+6565168014
phalycj@nus.edu.sg

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HSRG10MAY020

Study information

Scientific title

The effectiveness of pharmacist-involved collaborative care model in the management of patients with diabetes mellitus in Singapore

Acronym

Study hypothesis

The hypothesis of this study is that patients with diabetes under pharmacist-involved collaborative care will have greater improvements in all the clinical, humanistic and economic outcomes assessed than those under the conventional care.

Ethics approval

National University of Singapore Institutional Review Board and National Healthcare Group Domain Specific Review Board, 20/12/2012, 2012/01037

Study design

Multicenter, prospective, open-label, parallel-arm, randomized controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Type 2 diabetes and other chronic comorbidities such as hypertension and dyslipidemia

Intervention

Eligible patients will be randomized into the intervention or control arms:
1. Patients assigned to the intervention arm will receive active involvement of the pharmacist in drug optimization. The clinical interventions carried out by the pharmacist include but are not limited to counseling patients about drug therapy, performing simple physical assessments, ordering pertinent follow-up visits and laboratory tests on behalf of the physicians, and initiating, titrating, and terminating medications per clinical protocol and under the supervision of the physicians as appropriate. As needed, referrals to nurses and dieticians will also be actively made by the pharmacist and vice versa. The pharmacist will schedule clinic appointments approximately every six weeks, with a total of 4 pharmacist visits in the 6-month follow-up period. If the patient’s diabetes is well-controlled, i.e. with stable improvements in clinical measures, the pharmacist may replace one or two clinic visits with telephone counseling at his/her discretion.
2. Patients assigned to the control arm will receive the usual or conventional care from the physician with as needed referral at the discretion of the physician to the nurses for soft skill-related diabetes counseling and dietitians for diet control. These patients may be seen by different physicians at each visit, and pharmacists will not be involved in drug optimization except for dispensing.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Glycated hemoglobin (HbA1c),
2. Systolic blood pressure (SBP),
3. Low-density lipoprotein (LDL),
4. Triglycerides (TG)

Will be measured at baseline, three- and six-months

5. Incidence of minor and major hypoglycemia,
6. Appropriateness of aspirin and ACEI/ARB use,
7. Diabetes-related clinical visit and hospitalization
8. Morisky Medication Adherence Scale (MMAS),
9. Euro Quality of Life Five Dimensions (EQ-5D),
10. Audit of Diabetes-Dependent Quality of Life (ADDQoL),
11. Problem Areas in Diabetes (PAID),
12. Diabetes Treatment Satisfaction Questionnaires (DTSQ)
13. Direct and indirect costs

Will be measured at baseline and six-months

Secondary outcome measures

N/A

Overall trial start date

20/12/2012

Overall trial end date

13/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. 21 years and above
2. Diagnosed with type 2 diabetes
3. HbA1c ≥ 7%
4. Uncontrolled co-morbidities such as hypertension (>130/80 mm Hg) and dyslipidemia (LDL > 2.6 mmol/L and TG > 2.3 mmol/L)
5. Characteristics of CAREPILLS (defined as Closer monitoring, Adherence problem, Resistance to drug therapy, Empowerment in patient’s own therapy, Polypharmacy, Insulin titration, Lack in drug knowledge, Lack in drug administration techniques and Switching of drugs)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

At least 330 participants

Participant exclusion criteria

1. Diagnosed with type 1 diabetes
2. Unable to communicate independently

Recruitment start date

01/05/2013

Recruitment end date

01/04/2015

Locations

Countries of recruitment

Singapore

Trial participating centre

National Healthcare Group Health Institutions
138543
Singapore

Sponsor information

Organisation

National University of Singapore

Sponsor details

Department of Pharmacy
Faculty of Science
Block S4A
Level 3
18 Science Drive 4
Singapore
117543
Singapore
+6565162648
phalycj@nus.edu.sg

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Singapore Ministry of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes