Diabetes MellitusPACE-DNCT04288362
Patient Activation Through Community Empowerment/Engagement for Diabetes Management (PACE-D)
A study testing Intervention Group in people with Diabetes Mellitus and Chronic Disease, run by National University Health System, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Chronic Disease, Patient Care Planning
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,620 participants
- Where
- 1 siteSingapore
- Study dates
- 25 Mar 2019to 31 Mar 2022
- 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
- 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
Who cannot join
- Doctors, Care Managers and Care Coordinators involved in the care and support planning process
- Age 21 years and above
- Ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Diabetes Mellitus, Chronic Disease, Patient Care Planning, Patient Participation, Self Care, Empowerment
- Being tested
- Intervention Group, Control Group
- Keywords
- Diabetes, Long term conditions, Chronic disease management, Patient engagement, Patient empowerment, Self-management, Care Planning
- Medical subject headings
- Diabetes Mellitus, Chronic Disease, Patient Participation, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.
Control GroupOther
Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Intervention Group |
| Control Group | Active comparator | Not described Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
Change in HbA1c levels in patients receiving the CSP intervention compared with patients receiving standard care.
Measured: From baseline to study endpoint, one year in general
Secondary outcomes (10)
Change in mean Patient Activation Measures-13 (PAM-13) scores
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.
Measured: From baseline to study endpoint, one year in general
Change in proportion of patients in the various ranges of patient activation levels
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.
Measured: From baseline to study endpoint, one year in general
Change in healthcare utilisation in terms of number of polyclinic visits
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Two years in general from one year preceding recruitment to the period between first and second annual reviews
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start25 Mar 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Wee Hian, National University Health System, Singapore
- Investigators
- Doris Young, Study chair, National University Health System, SingaporeVictor Weng Keong Loh, Study director, National University Health System, SingaporeTong Wei Yew, Study director, National University Hospital, SingaporeKavita Venkataraman, Study director, National University of SingaporeBrent Gibbons, Study director, National University of SingaporeVikki Entwistle, Study director, National University of SingaporeSoon Guan Tan, Study director, National University of SingaporeMeena Sundram, Study director, National University Health System, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288362
- Sponsor's protocol ID
- CS-SN-03
- Acronym
- PACE-D
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2020
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25733495Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.
PubMed 8941260Bodenheimer 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.
PubMed 12377092Hibbard 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.
PubMed 15230939Tan 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.
PubMed 32560689
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04288362
- Acronym / sponsor ID
- PACE-D / CS-SN-03
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Collaborators
- National University Hospital, Singapore, National University of Singapore
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Feb 2020 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention Group |
| Control Group | Active comparator | Other: Control Group |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Doctors, Care Managers and Care Coordinators involved in the care and support planning process
- Age 21 years and above
- Ability to provide informed 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 |
|---|---|---|
| Intervention GroupParticipants in this arm will undergo the new care model for management of diabetes mellitus polyclinics. | Other | Intervention Group |
| Control GroupParticipants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics. | Other | Control Group |
Primary outcome
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.
10 secondary outcomes
Change in mean Patient Activation Measures-13 (PAM-13) scores
Time frame: 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 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 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 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 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 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 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 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 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
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 26 Apr 2022.
- Background: PubMed 25733495Coulter 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.
- Background: PubMed 8941260Wagner EH, Austin BT, Von Korff M. Organizing care for patients with chronic illness. Milbank Q. 1996;74(4):511-44.
- Background: PubMed 12377092Bodenheimer 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.
- Background: PubMed 15230939Hibbard 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.
- Derived from this study: PubMed 32560689Tan 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.
- 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.
Doris Young study chair
National University Health System, Singapore
Victor Weng Keong Loh study director
National University Health System, Singapore
Tong Wei Yew study director
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Diabetes Mellitus and Chronic Disease, run by National University Health System, 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 6 inclusion and 3 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 26 Apr 2022. 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. 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 levels (time frame: From baseline to study endpoint, one year in general). 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 NCT04288362, which also lists 5 linked publications.
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 26 Apr 2022.