Health BehaviorSHAPESNCT02745275
Supporting Healthy Aging by Peer Education and Support
A study testing Peer-led Health Education in people with Health Behavior and Ageing, run by University of Alberta at 1 site in Canada.
Trial summary
Canadians are living longer than ever before. However, many in our society age with long term chronic medical conditions which have a major impact on their need for healthcare, their quality of life and well-being. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Ageing
- What is being tested?
- Peer-led Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 20 Oct 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Both male and female community dwelling seniors who attend seniors centres in Edmonton
- Able to commit their time to participate in the study and complete the required assessments
- Speak and understand English
- Be under the care of or have access to a Family doctor
Who cannot join
- Medical or psychological impairment which might seriously impair adherence to the program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Division of Geriatric Medicine, Clinical Sciences Building, University of Alberta Hosp
Edmonton, Alberta, T6G 2P4
About this study
Official title: Supporting Healthy Aging by Peer Education and Support (SHAPES) - A Stepped-Wedge Cluster Randomized Trial
Canadians are living longer than ever before. However, many in our society age with long term chronic medical conditions which have a major impact on their need for healthcare, their quality of life and well-being. Encouragement of lifestyle practices which promote healthy aging and self-management techniques to deal with chronic disease is important in improving peoples' well-being
The purpose of this study is to study the impact of peer delivered education and support for seniors living in the community to see if training given to other seniors improves healthy ageing behaviours and their health literacy.
Read the detailed description
In Canada, between 1960 and 2009, the proportion of seniors (people aged ≥65 years) rose from 8% to 14%; it is estimated that this proportion will increase to 23-25% by 2036. The number of people in the population aged ≥80 years is projected to more than double between 2009 and 2036. This population ageing has, and will, have a major impact on healthcare, economics, education, employment and social engagement. Many in our society age with long term chronic medical conditions; the management of which is partly responsible for the increasing consumption of health care resources in later life. There is a pressing need on the part of health care providers and policy makers to contain these increasing expenditures. Encouragement of lifestyle practices which promote successful or healthy aging and self - management techniques to deal with chronic disease are therefore of paramount importance to the achievement of this goal. Cost containment, however, is not the sole reason for pursuing such practice; there is some evidence that self-management and an increase in health literacy leads to an increased sense of empowerment and an improvement in health related quality of life for seniors.
In the presence of chronic disease, self-management is seen as a critical element in containing resource demand and in empowering patients whilst increasing their health literacy. Self-management training courses have been developed for generic physical long term conditions which have led to improved outcomes and some cost savings in chronic care. There is therefore an opportunity to educate and empower seniors in both healthy ageing behaviours and self-management of chronic disease, which has the potential to contain health care resource use, improve perception of self-rated health and quality of life.
This study aims to explore the use of health coaches, where health coaching can be defined as helping patients gain the knowledge, skills, tools and confidence to become active participants in their care so that they can reach their self-identified health goals, drawn from community dwelling seniors, rather than "expert patients" in educating and supporting their peers in healthy aging behaviours and self-management of chronic disease.
- Conditions
- Health Behavior, Ageing
- Being tested
- Peer-led Health Education
- Keywords
- Peer Education, Health Coaches, Community Dwelling Seniors, Health Literacy, Health Education, Healthy Ageing
- Medical subject headings
- Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-led Health EducationBehavioural
Peer-led health education
| Study group | Role | What they receive |
|---|---|---|
| Peer-led Health Education | Experimental | A single 60 minute interactive workshop led by the trained health coach followed by a series of three one hour discussion groups Receives: Behavioral: Peer-led Health Education |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Rated Abilities for Healthy Practices Scale
Change in proportion of participating seniors engaged in healthy aging behaviours following the intervention compared to unexposed controls
Measured: 18 months
Secondary outcomes (5)
Change in physical activity levels measured by the Physical Activity Scale for the Elderly (PASE)
Measured: 12 months
Number of participants seeking health care as measured by Health care seeking and resource use questionnaire
Measured: 12 months
Measure self-efficacy for participating seniors using The General Self-Efficacy Scale (GES)
Measured: 12 months
Participant's willingness to change assessed by readiness to change ruler
Measured: 12 months
Number of participating seniors satisfied with the health coaches assessed by a semi-structured interviews
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start1 Sep 2017
- Primary completion20 Oct 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Covenant Health, Canada
- Responsible party
- Sponsor
- Investigators
- Adrian S Wagg, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745275
- Sponsor's protocol ID
- SHAPES-0915
- Acronym
- SHAPES
- Status last verified
- Oct 2019
- First submitted
- 13 Apr 2016
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005108. doi: 10.1002/14651858.CD005108.pub2.
PubMed 17943839Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
PubMed 12435261Fiocco AJ, Scarcello S, Marzolini S, Chan A, Oh P, Proulx G, Greenwood C. The effects of an exercise and lifestyle intervention program on cardiovascular, metabolic factors and cognitive performance in middle-aged adults with type II diabetes: a pilot study. Can J Diabetes. 2013 Aug;37(4):214-219. doi: 10.1016/j.jcjd.2013.03.369. Epub 2013 Aug 2.
PubMed 24070883Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
PubMed 10413387
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Healthy Aging by Peer Education and Support (SHAPES) - A Stepped-Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02745275
- Acronym / sponsor ID
- SHAPES / SHAPES-0915
- Conditions
- Health Behavior, Ageing
- Keywords
- Peer Education, Health Coaches, Community Dwelling Seniors, Health Literacy, Health Education, Healthy Ageing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Covenant Health, Canada
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 20 Apr 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.
Canadians are living longer than ever before. However, many in our society age with long term chronic medical conditions which have a major impact on their need for healthcare, their quality of life and well-being. Encouragement of lifestyle practices which promote healthy aging and self-management techniques to deal with chronic disease is important in improving peoples' well-being
The purpose of this study is to study the impact of peer delivered education and support for seniors living in the community to see if training given to other seniors improves healthy ageing behaviours and their health literacy.
Detailed description
In Canada, between 1960 and 2009, the proportion of seniors (people aged ≥65 years) rose from 8% to 14%; it is estimated that this proportion will increase to 23-25% by 2036. The number of people in the population aged ≥80 years is projected to more than double between 2009 and 2036. This population ageing has, and will, have a major impact on healthcare, economics, education, employment and social engagement. Many in our society age with long term chronic medical conditions; the management of which is partly responsible for the increasing consumption of health care resources in later life. There is a pressing need on the part of health care providers and policy makers to contain these increasing expenditures. Encouragement of lifestyle practices which promote successful or healthy aging and self - management techniques to deal with chronic disease are therefore of paramount importance to the achievement of this goal. Cost containment, however, is not the sole reason for pursuing such practice; there is some evidence that self-management and an increase in health literacy leads to an increased sense of empowerment and an improvement in health related quality of life for seniors.
In the presence of chronic disease, self-management is seen as a critical element in containing resource demand and in empowering patients whilst increasing their health literacy. Self-management training courses have been developed for generic physical long term conditions which have led to improved outcomes and some cost savings in chronic care. There is therefore an opportunity to educate and empower seniors in both healthy ageing behaviours and self-management of chronic disease, which has the potential to contain health care resource use, improve perception of self-rated health and quality of life.
This study aims to explore the use of health coaches, where health coaching can be defined as helping patients gain the knowledge, skills, tools and confidence to become active participants in their care so that they can reach their self-identified health goals, drawn from community dwelling seniors, rather than "expert patients" in educating and supporting their peers in healthy aging behaviours and self-management of chronic disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-led Health Education | Experimental | Behavioral: Peer-led Health EducationA single 60 minute interactive workshop led by the trained health coach followed by a series of three one hour discussion groups |
| Control | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Both male and female community dwelling seniors who attend seniors centres in Edmonton
- Able to commit their time to participate in the study and complete the required assessments
- Speak and understand English
- Be under the care of or have access to a Family doctor
Key exclusion criteria (1 listed)
- Medical or psychological impairment which might seriously impair adherence to the program
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 |
|---|---|---|
| Peer-led Health EducationPeer-led health education | Behavioural | Peer-led Health Education |
Primary outcome
Self-Rated Abilities for Healthy Practices Scale
Time frame: 18 months
Change in proportion of participating seniors engaged in healthy aging behaviours following the intervention compared to unexposed controls
5 secondary outcomes
Change in physical activity levels measured by the Physical Activity Scale for the Elderly (PASE)
Time frame: 12 months
Number of participants seeking health care as measured by Health care seeking and resource use questionnaire
Time frame: 12 months
Measure self-efficacy for participating seniors using The General Self-Efficacy Scale (GES)
Time frame: 12 months
Participant's willingness to change assessed by readiness to change ruler
Time frame: 12 months
Number of participating seniors satisfied with the health coaches assessed by a semi-structured interviews
Time frame: 12 months
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 4 Nov 2019.
- Background: PubMed 17943839Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005108. doi: 10.1002/14651858.CD005108.pub2.
- Background: PubMed 12435261Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.
- Background: PubMed 24070883Fiocco AJ, Scarcello S, Marzolini S, Chan A, Oh P, Proulx G, Greenwood C. The effects of an exercise and lifestyle intervention program on cardiovascular, metabolic factors and cognitive performance in middle-aged adults with type II diabetes: a pilot study. Can J Diabetes. 2013 Aug;37(4):214-219. doi: 10.1016/j.jcjd.2013.03.369. Epub 2013 Aug 2.
- Background: PubMed 10413387Lorig KR, Sobel DS, Stewart AL, Brown BW Jr, Bandura A, Ritter P, Gonzalez VM, Laurent DD, Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Med Care. 1999 Jan;37(1):5-14. doi: 10.1097/00005650-199901000-00003.
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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.
Adrian S Wagg, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-led Health Education in people with Health Behavior and Ageing, run by University of Alberta 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 4 inclusion and 1 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 4 Nov 2019. 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?
Self-Rated Abilities for Healthy Practices Scale (time frame: 18 months). 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 NCT02745275, which also lists 4 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 4 Nov 2019.