MultimorbidityNCT02209285
Self-Management Program for Older Adults With Multimorbidity
A study testing Self-Management Program for Older Adults with Multimorbidity in people with Multimorbidity, run by McMaster University at 1 site in Canada.
Trial summary
Patients with multimorbidity move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Self-Management Program for Older Adults with Multimorbidity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2017
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years of age and older;
- Three or more chronic conditions
- Newly referred (following initiation of the study) for home care services and living in the community, including supportive housing, retirement homes, and lodging homes and excluding long-term care;
- Able to speak English or have access to a translator;
- Not planning to move away from the CCAC catchment area in the next 6 months;
- Be mentally competent to provide informed consent, either independently or by a substitute decision maker.
Who cannot join
- Participants will be excluded if they are unable to read and understand English and do not have access to their own translator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management Program for Older Adults With Multimorbidity: A Pragmatic Randomized Controlled Trial
Patients with multimorbidity move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Recent Canadian studies and reports identify significant gaps in the delivery of effective care to patients with multiple chronic conditions in community-based settings.
The overall goal of the intervention is to promote successful management of chronic conditions, enhance quality of life, reduce the on-demand use of expensive health services and support primary caregivers (i.e. family or friends) who provide physical, emotional or financial care to an older adult with multimorbidity. This research program will leverage the tremendous potential to reduce the burden of multimorbidity by enhancing community-based prevention and chronic disease management.
This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of an interprofessional team-based self-management intervention on health-related quality of life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for older adults with multimorbidity receiving home care and their family caregivers. The results will inform: (1) the development of national standards for community-based care for patients with multimorbidity and (2) the development of a new and innovative community-based model for the management of multimorbidity that can be scaled up and spread across Canada.
Read the detailed description
Research Question:
What is the acceptability and effects of a six-month self-management program compared to usual home care services for older adults with multimorbidity and their family and friend caregivers?
Methods:
The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly referred to and using home care services. The intervention is a 6-month self-management program for older adults with multimorbidity. It will be provided by an interprofessional team of home care providers and will consist of three components: (1) intensive case management to facilitate access to services across the care continuum, provide psychosocial support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN), three visits by the Physiotherapist (PT) or Occupational Therapist (OT), and six visits by a Personal Support Worker (PSW) over 6 months in addition to usual home care services. The in-home visit schedule and team composition will be tailored to client needs and will be determined in collaboration with the home care providers. The interprofessional (IP) team will conduct comprehensive screening and assessments for chronic conditions, utilize strengths-based practice to encourage self-management and foster behavioural change, provide education for multimorbidity, medication review and management, in-home exercise, and caregiver support; and (3) monthly interprofessional team case conferences to develop an IP evidence-based, patient-centred care plan.
Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables. Analysis of covariance will be used to compare study groups, while adjusting for baseline measurements and potential confounding variables. Subgroup analyses will be conducted based on sex/gender and region.
Expected Outcomes:
It is expected that older adults receiving the intervention will show greater improvements in health-related quality of life compared to usual home care services. These improvements will be achieved at no additional cost, from a societal perspective.
- Conditions
- Multimorbidity
- Being tested
- Self-Management Program for Older Adults with Multimorbidity
- Keywords
- Older adults, Home and community care, Effectiveness, Cost analysis, Pragmatic trial, Self-management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Management Program for Older Adults with MultimorbidityBehavioural
Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis. |
| Self-Management Program for Older Adults with Multimorbidity | Active comparator | Individuals in the intervention group will receive a six-month self-management intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan. Receives: Behavioral: Self-Management Program for Older Adults with Multimorbidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.
Measured: Baseline and end of study (6 months from baseline)
Secondary outcomes (7)
Generalized Anxiety Disorder Screener (GAD-7) Scale
The GAD-7 will be administered to older adult participants at baseline and 6 months to assess anxiety.
Measured: Baseline and end of study (6 months from baseline)
Health and Social Services Utilization Inventory (HSSUI)
The HSSUI will be administered to older adult participants at baseline and 6 months to assess healthcare utilization costs.
Measured: Baseline and end of study (6 months from baseline)
Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)
The CES-D-10 will be administered to older adult participants at baseline and 6 months to assess depressive symptoms
It is estimated that approximately 70% of the study participants will have a family caregiver.
Measured: Baseline and end of study (6 months from baseline)
Collaborative Practice Assessment Tool (CPAT)
The CPAT will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess changes in collaborative practice.
Measured: At 3 months and at 9 months after the start of the study
Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.
Measured: Baseline and end of study (6 months from baseline)
Self-efficacy for managing chronic disease scale
The self-efficacy for managing chronic disease scale will be administered to older adult participants to assess their level of self-efficacy
Measured: Baseline and end of study (6 months from baseline)
Team Climate Inventory-19 (TCI-19)
The TCI-19 will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess the level of team functioning.
Measured: At 3 months and at 9 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startJan 2016
- Primary completionApr 2017
- Study completionDec 2017
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 MultimorbidityStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen Markle-Reid, McMaster University
- Investigators
- Maureen Markle-Reid, RN, PhD, Principal investigator, McMaster University, School of NursingJenny Ploeg, RN, PhD, Principal investigator, McMaster University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209285
- Sponsor's protocol ID
- STRCT- 06669
- Status last verified
- Jan 2020
- First submitted
- 7 Jul 2014
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
PubMed 30191144
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management Program for Older Adults With Multimorbidity: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02209285
- Acronym / sponsor ID
- STRCT- 06669
- Conditions
- Multimorbidity
- Keywords
- Older adults, Home and community care, Effectiveness, Cost analysis, Pragmatic trial, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Aug 2014 (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.
Patients with multimorbidity move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Recent Canadian studies and reports identify significant gaps in the delivery of effective care to patients with multiple chronic conditions in community-based settings.
The overall goal of the intervention is to promote successful management of chronic conditions, enhance quality of life, reduce the on-demand use of expensive health services and support primary caregivers (i.e. family or friends) who provide physical, emotional or financial care to an older adult with multimorbidity. This research program will leverage the tremendous potential to reduce the burden of multimorbidity by enhancing community-based prevention and chronic disease management.
This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of an interprofessional team-based self-management intervention on health-related quality of life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for older adults with multimorbidity receiving home care and their family caregivers. The results will inform: (1) the development of national standards for community-based care for patients with multimorbidity and (2) the development of a new and innovative community-based model for the management of multimorbidity that can be scaled up and spread across Canada.
Detailed description
Research Question:
What is the acceptability and effects of a six-month self-management program compared to usual home care services for older adults with multimorbidity and their family and friend caregivers?
Methods:
The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly referred to and using home care services. The intervention is a 6-month self-management program for older adults with multimorbidity. It will be provided by an interprofessional team of home care providers and will consist of three components: (1) intensive case management to facilitate access to services across the care continuum, provide psychosocial support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN), three visits by the Physiotherapist (PT) or Occupational Therapist (OT), and six visits by a Personal Support Worker (PSW) over 6 months in addition to usual home care services. The in-home visit schedule and team composition will be tailored to client needs and will be determined in collaboration with the home care providers. The interprofessional (IP) team will conduct comprehensive screening and assessments for chronic conditions, utilize strengths-based practice to encourage self-management and foster behavioural change, provide education for multimorbidity, medication review and management, in-home exercise, and caregiver support; and (3) monthly interprofessional team case conferences to develop an IP evidence-based, patient-centred care plan.
Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables. Analysis of covariance will be used to compare study groups, while adjusting for baseline measurements and potential confounding variables. Subgroup analyses will be conducted based on sex/gender and region.
Expected Outcomes:
It is expected that older adults receiving the intervention will show greater improvements in health-related quality of life compared to usual home care services. These improvements will be achieved at no additional cost, from a societal perspective.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis. |
| Self-Management Program for Older Adults with Multimorbidity | Active comparator | Behavioral: Self-Management Program for Older Adults with MultimorbidityIndividuals in the intervention group will receive a six-month self-management intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 65 years of age and older;
- Three or more chronic conditions
- Newly referred (following initiation of the study) for home care services and living in the community, including supportive housing, retirement homes, and lodging homes and excluding long-term care;
- Able to speak English or have access to a translator;
- Not planning to move away from the CCAC catchment area in the next 6 months;
Key exclusion criteria (1 listed)
- Participants will be excluded if they are unable to read and understand English and do not have access to their own translator
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 |
|---|---|---|
| Self-Management Program for Older Adults with MultimorbidityIndividuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan. | Behavioural | Self-Management Program for Older Adults with Multimorbidity |
Primary outcome
Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
Time frame: Baseline and end of study (6 months from baseline)
The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.
7 secondary outcomes
Generalized Anxiety Disorder Screener (GAD-7) Scale
Time frame: Baseline and end of study (6 months from baseline)
Health and Social Services Utilization Inventory (HSSUI)
Time frame: Baseline and end of study (6 months from baseline)
Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)
Time frame: Baseline and end of study (6 months from baseline)
Collaborative Practice Assessment Tool (CPAT)
Time frame: At 3 months and at 9 months after the start of the study
Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
Time frame: Baseline and end of study (6 months from baseline)
Self-efficacy for managing chronic disease scale
Time frame: Baseline and end of study (6 months from baseline)
Team Climate Inventory-19 (TCI-19)
Time frame: At 3 months and at 9 months after the start of the study
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 30 Jan 2020.
- Derived from this study: PubMed 30191144Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
- 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.
Maureen Markle-Reid, RN, PhD principal investigator
McMaster University, School of Nursing
Jenny Ploeg, RN, PhD principal investigator
McMaster University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Management Program for Older Adults with Multimorbidity in people with Multimorbidity, 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 6 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 30 Jan 2020. 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?
Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2) (time frame: Baseline and end of study (6 months from baseline)). 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 NCT02209285, 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 30 Jan 2020.