Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D) (PACE-D)

April 25, 2022 updated by: Tan Wee Hian, National University Health System, Singapore

The Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D) Protocol: A Non-randomised Controlled Trial of Personalised Care and Support Planning for Persons Living With Diabetes

The study is a non-randomised controlled trial involving an intervention group and a control group. It aims to evaluate the effects of a patient engagement and empowerment model of collaborative care support planning on clinical outcomes of patients with diabetes mellitus as compared to usual care in the primary care setting. It also aims will be to examine the impact of the intervention on patient activation, patient and healthcare provider experience, and healthcare utilisation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will conduct a prospective study on existing patients with diabetes who are on follow-up with their teamlets at Pioneer (PIO), Jurong (JUR), Bukit Batok (BBK) and Choa Chu Kang (CCK) polyclinics for management of diabetes. Recruitment will occur for 18 months from the time of study implementation. One teamlet in JUR and one teamlet in PIO (total of two teamlets) will fall under intervention arm where the new care model based on the Year-of-Care (YOC) model will be delivered, whereas one teamlet in BBK and one teamlet in CCK (total of another two teamlets) will fall under the control arm where the current teamlet model will be continued.

In the intervention group, patients recruited will undergo the new care model which entails receiving the Care Planning Results Letter before the consultation at their annual review, involving them in the Care and Support Planning (CSP) consultation at the annual review, and referring them to suitable community resources to support self-management. The Care Planning Results Letter prompts patients to think the issues they would like to raise to their Doctor or Care Manager (who is a nurse trained in chronic disease management), checks on their mood, provides information on their most recent few laboratory test results, clinical parameters, smoking status, and attendances for foot and eye screenings. The letter also covers goal setting and action planning discussions. The patient is expected to bring it for the upcoming CSP consultation at the annual review. The CSP is a conversation which is conducted by the Doctor or Care Manager trained in the new care model. It focuses on a collaborative approach between the health care providers and the patient for joint goal setting and shared decision making to support self-management of their chronic condition(s).

In the control arm, the participants will receive the usual care with the teamlet model. There will not be any Care Planning Results Letter prepared for the patient. At the upcoming annual visit, the patient will continue to have the usual annual review for the laboratory test results and consultation. A flyer that lists the community programmes that support the patient for self-management will also be issued to the patient. If the patient is interested in any of these programmes, they may sign up with the respective community providers directly.

After the first CSP, selected patient participants may be invited for a one-to-one in-depth interviews (IDIs) to explore their perceptions about diabetes, diabetes management and the intervention programme in greater detail. The interviews will be conducted by researchers trained qualitative research methodology. They will be semi-structured with a topic guide to support exploration of the themes of interest, and will be informed by prior qualitative research with this and other similar interventions, as well as the results from the patient surveys. Health care providers who are involved in the delivery of CSPs in the intervention arm will also be invited for a one-to-one in-depth interviews (IDIs), to develop an understanding of how they find the training and new way of working with patients (particularly the care and support planning conversation).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1620

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 609606
        • National University Polyclinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On follow up with an existing teamlet pre-assigned to participate in the study
  • Adults with diabetes mellitus
  • Age 21 years and above
  • Ability to provide informed consent
  • Ability to communicate in the language(s) which the physician is confident to carry out the care and support planning consult in English, Malay or Chinese
  • Ability to read and comprehend the Diabetes Results Letter on their own OR has family members who are able to assist to that

Exclusion Criteria:

  • Doctors, Care Managers and Care Coordinators involved in the care and support planning process
  • Age 21 years and above
  • Ability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Other: Intervention Group
Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.
Active Comparator: Control Group
Other: Control Group
Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c levels
Time Frame: From baseline to study endpoint, one year in general
Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in mean Patient Activation Measures-13 (PAM-13) scores
Time Frame: From baseline to study endpoint, one year in general
Change in mean Patient Activation Measures-13 (PAM-13) scores in patients receiving the CSP intervention compared with patients receiving standard care. PAM-13 is a validated tool with 13-item response rated on a 4-point Likert-type scale that will be converted to a linear score of 0 (lowest patient activation) to 100 (highest patient activation). Higher patient activation score from PAM-13 is associated better healthcare outcomes such as medication adherence.
From baseline to study endpoint, one year in general
Change in proportion of patients in the various ranges of patient activation levels
Time Frame: From baseline to study endpoint, one year in general
Change in proportion of patients in the various ranges of patient activation levels for patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in healthcare utilisation in terms of number of polyclinic visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of polyclinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of emergency department visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of emergency department visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of hospital inpatient admissions
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of hospital inpatient admissions for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of proportion (%) of patients with specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of specialist outpatient clinic visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare utilisation in terms of number of specialist outpatient clinic visits for patients receiving CSP intervention compared with patients receiving standard care, assessed through retrospective analysis of electronic medical records.
Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits
Time Frame: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Change in healthcare cost in terms of total healthcare cost of polyclinic, emergency department, hospital admissions and specialist outpatient clinic visits in patients receiving the CSP intervention compared with patients receiving standard care.
Two years in general from one year preceding recruitment to the period between first and second annual reviews

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in proportion of patients meeting their target blood pressure levels
Time Frame: From baseline to study endpoint, one year in general
Change in proportion of patients meeting their target blood pressure levels for patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in proportion of patients meeting their target LDL-cholesteterol levels
Time Frame: From baseline to study endpoint, one year in general
Change in proportion of patients meeting their target LDL-cholesteterol levels for patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in body weight
Time Frame: From baseline to study endpoint, one year in general
Change in body weight (kg) in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in exercise duration
Time Frame: From baseline to study endpoint, one year in general
Change in exercise duration (minutes per week) in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in smoking rates
Time Frame: From baseline to study endpoint, one year in general
Change in smoking rates (cigarettes per day) in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in the proportion (%) of patients who indicate community resource utilisation
Time Frame: From baseline to study endpoint, one year in general
Change in the proportion (%) of patients who indicate community resource utilisation in the past 1 year between patients CSP intervention compared with patients receiving standard care. Community resource utilisation history is assessed through dichotomous questionnaire with yes/no response.
From baseline to study endpoint, one year in general
Change in Diabetes Foot Screening rates
Time Frame: From baseline to study endpoint, one year in general
Change in Diabetes Foot Screening Rates in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general
Change in Diabetes Retinal Photography rates
Time Frame: From baseline to study endpoint, one year in general
Change in Diabetes Retinal Photography rates in patients receiving the CSP intervention compared with patients receiving standard care.
From baseline to study endpoint, one year in general

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Health System, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National University Hospital, Singapore
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Doris Young, National University Health System, Singapore
  • Study Director: Victor Weng Keong Loh, National University Health System, Singapore
  • Study Director: Tong Wei Yew, National University Hospital, Singapore
  • Study Director: Kavita Venkataraman, National University of Singapore
  • Study Director: Brent Gibbons, National University of Singapore
  • Study Director: Vikki Entwistle, National University of Singapore
  • Study Director: Soon Guan Tan, National University of Singapore
  • Study Director: Meena Sundram, National University Health System, Singapore
  • Study Director: Keith Tsou, National University Health System, Singapore
  • Study Director: Yii Jen Lew, National University Health System, Singapore
  • Principal Investigator: Wee Hian Tan, National University Health System, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS-SN-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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