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

NCT04288362 | Completed

• 1 other identifier: CS-SN-03
• Study Type: interventional
• Target: 1,620
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Chronic Disease; Patient Care Planning; Patient Participation; Self Care; Empowerment

Keywords

Diabetes; Long term conditions; Chronic disease management; Patient engagement; Patient empowerment; Self-management; Care Planning

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c levels

  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 Outcomes (10)

• Change in mean Patient Activation Measures-13 (PAM-13) scores

  From baseline to study endpoint, one year in general

• Change in proportion of patients in the various ranges of patient activation levels

  From baseline to study endpoint, one year in general

• Change in healthcare utilisation in terms of number of polyclinic visits

  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

  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

  Two years in general from one year preceding recruitment to the period between first and second annual reviews

Other Outcomes (8)

• Change in proportion of patients meeting their target blood pressure levels

  From baseline to study endpoint, one year in general

• Change in proportion of patients meeting their target LDL-cholesteterol levels

  From baseline to study endpoint, one year in general

• Change in body weight

  From baseline to study endpoint, one year in general

Study Arms (2)

Intervention Group

EXPERIMENTAL

Other: Intervention Group

Control Group

ACTIVE COMPARATOR

Other: Control Group

Interventions

Intervention Group OTHER

Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.

Intervention Group

Control Group OTHER

Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.

Control Group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University Health System, Singapore: lead
• National University Hospital, Singapore: collaborator
• National University of Singapore: collaborator

Study Sites (1)

National University Polyclinics

Singapore, 609606, Singapore

Location

Related Publications (5)

• Coulter A, Entwistle VA, Eccles A, Ryan S, Shepperd S, Perera R. Personalised care planning for adults with chronic or long-term health conditions. Cochrane Database Syst Rev. 2015 Mar 3;2015(3):CD010523. doi: 10.1002/14651858.CD010523.pub2.

  PMID: 25733495 BACKGROUND

• Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.

  PMID: 8941260 BACKGROUND

• Bodenheimer T, Wagner EH, Grumbach K. Improving primary care for patients with chronic illness: the chronic care model, Part 2. JAMA. 2002 Oct 16;288(15):1909-14. doi: 10.1001/jama.288.15.1909.

  PMID: 12377092 BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Tan WH, Loh VWK, Venkataraman K, Choong ST, Lew YJ, Sundram M, Tsou K, Tan SG, Gibbons B, Entwistle V, Young D, Tai ES, Yew TW. 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. BMC Fam Pract. 2020 Jun 19;21(1):114. doi: 10.1186/s12875-020-01173-2.

  PMID: 32560689 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease; Patient Participation; Empowerment

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Doris Young

  National University Health System, Singapore

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Wee Hian Tan

  National University Health System, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PACE-D Programme Director, Consultant Family Physician

Model Details: Non-randomised controlled trial

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 28, 2020
• Study Start: March 25, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)