Cardiovascular DiseasesCHAP-EMSNCT02772263
Pilot Project: Community Health Assessment Program Through Emergency Medical Services
A study testing CHAP-EMS in people with Cardiovascular Diseases and Diabetes Mellitus, run by McMaster University at 1 site in Canada.
Trial summary
Older adults living in subsidized housing report poorer health. Their low income and age make it harder for them to use community services. Many older adults have heart disease and diabetes, which lead to frequent emergency calls and hospital admissions. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus
- What is being tested?
- CHAP-EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Dec 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living in intervention building
- Aged 65 or over
Who cannot join
- Not living in intervention building
- Under aged 65
Trial locations and contacts
1 site in 1 country.
About this study
Older adults living in subsidized housing report poorer health. Their low income and age make it harder for them to use community services. Many older adults have heart disease and diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the costs of treating heart disease and diabetes through emergency and hospitalization, improved screening and health education is needed. The Community Health Assessment Program through Emergency Medical Services (CHAP-EMS) program will take place in communal areas within housing buildings of older adults and deliver a heart disease, diabetes, and falls risk check-up with health education. This is expected to improve the health of older adults leading to fewer emergency calls and hospital visits.
Paramedics on modified duties (e.g. injured) will conduct weekly, one-on-one drop-in sessions for seniors in a common area of one subsidized apartment building in Hamilton, Ontario.
Read the detailed description
The CHAP-EMS research team has created a multifaceted intervention (cardiovascular, diabetes, and falls risk assessment with health education/promotion and appropriate referral) in partnership with Hamilton Paramedic Service, City Housing Hamilton (CHH), and the Community Care Access Center (CCAC) that focuses on issues experienced by older adults that often lead to EMS calls. CHAP-EMS is based on the Cardiovascular Health Awareness Program (CHAP) model, which combined individual- and population-level strategies for primary prevention and 'closed the loop' by linking participants to follow-up care. Literature demonstrates that the CHAP program resulted in a significant 9% relative reduction in admissions due to stroke, heart failure, and heart attacks in people aged 65 and over.
The original CHAP program was run by trained volunteers. This modified program will be run by accommodated paramedics (unable to assume traditional paramedic duties due to personal limitations such as pregnancy or injuries). Subsidized housing buildings house frail, seriously ill and potentially unstable individuals who may require immediate assistance. Paramedics are an excellent fit to deal with these emergent situations since their training prepares them to accurately assess the patient's health status and the environmental context, and connect patients with primary care physicians, visiting nurses, and community services including falls prevention; these skills can be expanded to provide non-urgent health care services and health promotion work. EMS administrators indicate that there is no shortage of accommodated staff at the Hamilton Paramedic Service and work considered as light duties is scarce.
The objectives are to evaluate whether a weekly 8-hour CHAP-EMS program is associated with changes in (1) number of emergency (911) EMS calls from the seniors' residence building, (2) mean blood pressure (BP) of participants and (3) diabetes risk profile of participants after one year of implementation.
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus
- Being tested
- CHAP-EMS
- Keywords
- Paramedicine, Community Paramedic, Elderly
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAP-EMSOther
The CHAP-EMS program is a low cost community program that is designed to assess community dwelling seniors for lifestyle risk factors that may impact their health and well-being and to provide targeted education to address the pertinent risk factors. Each participant is guided through a structured health-risk assessment focused on diabetes, cardiovascular disease and other potential health issues. The assessment is conducted by a trained paramedic in a common area within the community housing building. Data gathered are used to develop individualized action plans concerning health-risk reduction, to direct participants to local health activities or resources, educate on promoting health and to transmit this information to a participants' family physician.
| Study group | Role | What they receive |
|---|---|---|
| CHAP-EMS Intervention | Experimental | Participants guided through a 15-20 minute defined risk assessment by a trained paramedic. Risk factors assessed were those related to cardiovascular and diabetes risk (blood pressure, diabetes-risk status, lifestyle factors), and potential for falls. Based on these, the paramedic provided education and developed an individualized action plan directing participants to use available community resources to assist them in addressing their risk factors. They were advised to return to CHAP-EMS sessions regularly for BP monitoring and follow-up. Each participant's information was faxed to his/her family physician once a month. Receives: Other: CHAP-EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of EMS calls over 1 year
Building-level change in EMS call rate (pre-post intervention)
Measured: Baseline and 1 year
Secondary outcomes (2)
Change in systolic and diastolic blood pressure over 1 year
Since the participants are invited to attend the intervention weekly, but are not required to attend, the number of assessments and time of assessments will vary. Multilevel analysis will be conducted that accounts for this variance in repeated measures.
Measured: Baseline and after each assessment (up to 1 year)
Change in Canadian Diabetes Risk (CANRISK) score over 1 year
The CANRISK tool provides a 10-year risk of diabetes score and will be administered by the paramedic during the CHAP-EMS session.
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gina Agarwal, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772263
- Sponsor's protocol ID
- 14 210
- Acronym
- CHAP-EMS
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Agarwal G, Angeles R, Pirrie M, Marzanek F, McLeod B, Parascandalo J, Dolovich L. Effectiveness of a community paramedic-led health assessment and education initiative in a seniors' residence building: the Community Health Assessment Program through Emergency Medical Services (CHAP-EMS). BMC Emerg Med. 2017 Mar 9;17(1):8. doi: 10.1186/s12873-017-0119-4.
PubMed 28274221
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project: Community Health Assessment Program Through Emergency Medical Services
- ClinicalTrials.gov ID
- NCT02772263
- Acronym / sponsor ID
- CHAP-EMS / 14 210
- Conditions
- Cardiovascular Diseases, Diabetes Mellitus
- Keywords
- Paramedicine, Community Paramedic, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 2016 (estimated)
- 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.
Older adults living in subsidized housing report poorer health. Their low income and age make it harder for them to use community services. Many older adults have heart disease and diabetes, which lead to frequent emergency calls and hospital admissions. To decrease the costs of treating heart disease and diabetes through emergency and hospitalization, improved screening and health education is needed. The Community Health Assessment Program through Emergency Medical Services (CHAP-EMS) program will take place in communal areas within housing buildings of older adults and deliver a heart disease, diabetes, and falls risk check-up with health education. This is expected to improve the health of older adults leading to fewer emergency calls and hospital visits.
Paramedics on modified duties (e.g. injured) will conduct weekly, one-on-one drop-in sessions for seniors in a common area of one subsidized apartment building in Hamilton, Ontario.
Detailed description
The CHAP-EMS research team has created a multifaceted intervention (cardiovascular, diabetes, and falls risk assessment with health education/promotion and appropriate referral) in partnership with Hamilton Paramedic Service, City Housing Hamilton (CHH), and the Community Care Access Center (CCAC) that focuses on issues experienced by older adults that often lead to EMS calls. CHAP-EMS is based on the Cardiovascular Health Awareness Program (CHAP) model, which combined individual- and population-level strategies for primary prevention and 'closed the loop' by linking participants to follow-up care. Literature demonstrates that the CHAP program resulted in a significant 9% relative reduction in admissions due to stroke, heart failure, and heart attacks in people aged 65 and over.
The original CHAP program was run by trained volunteers. This modified program will be run by accommodated paramedics (unable to assume traditional paramedic duties due to personal limitations such as pregnancy or injuries). Subsidized housing buildings house frail, seriously ill and potentially unstable individuals who may require immediate assistance. Paramedics are an excellent fit to deal with these emergent situations since their training prepares them to accurately assess the patient's health status and the environmental context, and connect patients with primary care physicians, visiting nurses, and community services including falls prevention; these skills can be expanded to provide non-urgent health care services and health promotion work. EMS administrators indicate that there is no shortage of accommodated staff at the Hamilton Paramedic Service and work considered as light duties is scarce.
The objectives are to evaluate whether a weekly 8-hour CHAP-EMS program is associated with changes in (1) number of emergency (911) EMS calls from the seniors' residence building, (2) mean blood pressure (BP) of participants and (3) diabetes risk profile of participants after one year of implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHAP-EMS Intervention | Experimental | Other: CHAP-EMSParticipants guided through a 15-20 minute defined risk assessment by a trained paramedic. Risk factors assessed were those related to cardiovascular and diabetes risk (blood pressure, diabetes-risk status, lifestyle factors), and potential for falls. Based on these, the paramedic provided education and developed an individualized action plan directing participants to use available community resources to assist them in addressing their risk factors. They were advised to return to CHAP-EMS sessions regularly for BP monitoring and follow-up. Each participant's information was faxed to his/her family physician once a month. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Living in intervention building
- Aged 65 or over
Key exclusion criteria (2 listed)
- Not living in intervention building
- Under aged 65
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 |
|---|---|---|
| CHAP-EMSThe CHAP-EMS program is a low cost community program that is designed to assess community dwelling seniors for lifestyle risk factors that may impact their health and well-being and to provide targeted education to address the pertinent risk factors. Each participant is guided through a structured health-risk assessment focused on diabetes, cardiovascular disease and other potential health issues. The assessment is conducted by a trained paramedic in a common area within the community housing building. Data gathered are used to develop individualized action plans concerning health-risk reduction, to direct participants to local health activities or resources, educate on promoting health and to transmit this information to a participants' family physician. | Other | CHAP-EMS Intervention |
Primary outcome
Change in rate of EMS calls over 1 year
Time frame: Baseline and 1 year
Building-level change in EMS call rate (pre-post intervention)
2 secondary outcomes
Change in systolic and diastolic blood pressure over 1 year
Time frame: Baseline and after each assessment (up to 1 year)
Change in Canadian Diabetes Risk (CANRISK) score over 1 year
Time frame: Baseline and 1 year
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 13 May 2016.
- Derived from this study: PubMed 28274221Agarwal G, Angeles R, Pirrie M, Marzanek F, McLeod B, Parascandalo J, Dolovich L. Effectiveness of a community paramedic-led health assessment and education initiative in a seniors' residence building: the Community Health Assessment Program through Emergency Medical Services (CHAP-EMS). BMC Emerg Med. 2017 Mar 9;17(1):8. doi: 10.1186/s12873-017-0119-4.
- 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.
Gina Agarwal principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAP-EMS in people with Cardiovascular Diseases and Diabetes Mellitus, run by McMaster University at 1 site in Canada.
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 2 inclusion and 2 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 13 May 2016. 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 Canada. 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 rate of EMS calls over 1 year (time frame: Baseline and 1 year). 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 NCT02772263, 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 13 May 2016.