Older AdultsNCT06603610
Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults
A study testing Intensive geriatric service worker model of care and Information brochure and telephone follow-up support in people with Older Adults and Social Isolation, run by Unity Health Toronto.
Trial summary
In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant: (i) Coordinate community resources and actively… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Adults, Social Isolation
- What is being tested?
- Intensive geriatric service worker model of care and Information brochure and telephone follow-up support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 2026
- 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
- adults aged ≥65 years old (ii) socially isolated, defined as living alone (iii) identified by the multidisciplinary Acute Care of the Elderly team, Internal Consultation Team, or Elders' Clinic as having one or more instrumental activity of daily living (IADL) impairments (defined as per the Lawton IADL scale) that could be supported by the intensive geriatric service worker (iv) capable of consenting to study participation or have a substitute decision-maker who can provide consent on their behalf (v) able to understand and communicate in English (e.g., if a participant is hearing impaired, but they can lip read or hear sufficiently with a hearing aid, they will be included) or know someone who can help with translation (vi) living in a private dwelling (e.g., apartment, house, condominium) within a geographical catchment area (i.e., boundaries will be Bloor St, Don Valley Parkway, Lakeshore Blvd, and Yonge St) (vii) a patient of a family physician or nurse practitioner (or be willing to become a patient of a family physician or nurse practitioner).
Who cannot join
- live in a retirement home, long-term care home or shelter (because there is varying availability of resources to support patients' activities of daily living (ADLs) and IADLs in these settings and we want to implement the IGSW care model where we hypothesize that it will have the greatest impact (ii) do not have a fixed address (iii) are participating in another study (iv) are being transferred to a rehabilitation facility other than Providence Healthcare prior to discharge home (Providence Healthcare is a collaborating study site; our team has an ongoing research collaboration with the medical rehabilitation unit at Providence Healthcare [where ACE and ICT medical consultation patients are transferred]
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults: a Pilot Randomized Trial
In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant:
(i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).
Read more
Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans.
We are interested in learning about the number and demographic characteristics of participants we will be able to recruit to the study, who will remain in the study and who will be adherent to their prioritized treatment recommendations. We are also interested in learning about changes in participants' quality of life, proportion of IADLs being completed independently or with support, emergency department visit rate, and hospitalization rate at 3 and 6 months.
- Conditions
- Older Adults, Social Isolation
- Being tested
- Intensive geriatric service worker model of care, Information brochure and telephone follow-up support
- Keywords
- older adults, social isolation
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive geriatric service worker model of careOther
Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant:
(i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).
Information brochure and telephone follow-up supportOther
Participants will be e-mailed or mailed a booklet containing information about locally available resources including (1) meal preparation, (2) grocery delivery, (3) housekeeping, (4) pharmacies that deliver medications, (5) home care, and (6) Wheel-Trans. Participants will receive a scripted phone call from the study research coordinator one and three months after study enrolment to see if they have questions about the booklet material.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants in this arm will receive the intervention. Receives: Other: Intensive geriatric service worker model of care |
| Control | Placebo comparator | Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans. Participants in this arm will also receive telephone follow-up support. Receives: Other: Information brochure and telephone follow-up support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Feasibility
The number of participants (i) recruited (over the entire 12-month recruitment period and per month), (ii) retained (remain in the IGSW care model until prioritized recommendations are implemented, are discharged from the program because they are admitted to a retirement or LTC home, or complete the intervention; number of participants in the control group who provide follow-up data at 3 and 6 months) (iii) fully adherent to patients' prioritized recommendations during the trial period (% full adherence to [a] all prioritized recommendations, [b] >75% of prioritized recommendations, and [c] ≥1 prioritized recommendation at 3 and 6 months) and (iv) sustained linkages to community agencies to provide ADL and IADL support (number of participants with linkages to [a] all community agencies, [b] ≥1 community agency at 3 and 6 months).
Measured: Between 3 months to 1 year
Secondary outcomes (6)
Quality of Life
Change in quality of life will be measured with the EQ-5D-5L
Measured: 3 and 6 months
Proportion of IADLs being completed independently or with support
Measured: 3 and 6 months
Emergency department visit rate
Measured: 3 and 6 months
Hospitalization rate
Measured: 3 and 6 months
Long-term care home admission rate
Measured: 3 and 6 months
Length of hospitalization
This will be measured for study participants admitted to hospital.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603610
- Sponsor's protocol ID
- 23-277
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06603610
- Acronym / sponsor ID
- 23-277
- Conditions
- Older Adults, Social Isolation
- Keywords
- older adults, social isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant:
(i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).
Participants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans.
We are interested in learning about the number and demographic characteristics of participants we will be able to recruit to the study, who will remain in the study and who will be adherent to their prioritized treatment recommendations. We are also interested in learning about changes in participants' quality of life, proportion of IADLs being completed independently or with support, emergency department visit rate, and hospitalization rate at 3 and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Intensive geriatric service worker model of careParticipants in this arm will receive the intervention. |
| Control | Placebo comparator | Other: Information brochure and telephone follow-up supportParticipants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans. Participants in this arm will also receive telephone follow-up support. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- adults aged ≥65 years old (ii) socially isolated, defined as living alone (iii) identified by the multidisciplinary Acute Care of the Elderly team, Internal Consultation Team, or Elders' Clinic as having one or more instrumental activity of daily living (IADL) impairments (defined as per the Lawton IADL scale) that could be supported by the intensive geriatric service worker (iv) capable of consenting to study participation or have a substitute decision-maker who can provide consent on their behalf (v) able to understand and communicate in English (e.g., if a participant is hearing impaired, but they can lip read or hear sufficiently with a hearing aid, they will be included) or know someone who can help with translation (vi) living in a private dwelling (e.g., apartment, house, condominium) within a geographical catchment area (i.e., boundaries will be Bloor St, Don Valley Parkway, Lakeshore Blvd, and Yonge St) (vii) a patient of a family physician or nurse practitioner (or be willing to become a patient of a family physician or nurse practitioner).
Key exclusion criteria (1 listed)
- live in a retirement home, long-term care home or shelter (because there is varying availability of resources to support patients' activities of daily living (ADLs) and IADLs in these settings and we want to implement the IGSW care model where we hypothesize that it will have the greatest impact (ii) do not have a fixed address (iii) are participating in another study (iv) are being transferred to a rehabilitation facility other than Providence Healthcare prior to discharge home (Providence Healthcare is a collaborating study site; our team has an ongoing research collaboration with the medical rehabilitation unit at Providence Healthcare [where ACE and ICT medical consultation patients are transferred]
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 |
|---|---|---|
| Intensive geriatric service worker model of careParticipants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant: (i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences). | Other | Intervention |
| Information brochure and telephone follow-up supportParticipants will be e-mailed or mailed a booklet containing information about locally available resources including (1) meal preparation, (2) grocery delivery, (3) housekeeping, (4) pharmacies that deliver medications, (5) home care, and (6) Wheel-Trans. Participants will receive a scripted phone call from the study research coordinator one and three months after study enrolment to see if they have questions about the booklet material. | Other | Control |
Primary outcome
Implementation Feasibility
Time frame: Between 3 months to 1 year
The number of participants (i) recruited (over the entire 12-month recruitment period and per month), (ii) retained (remain in the IGSW care model until prioritized recommendations are implemented, are discharged from the program because they are admitted to a retirement or LTC home, or complete the intervention; number of participants in the control group who provide follow-up data at 3 and 6 months) (iii) fully adherent to patients' prioritized recommendations during the trial period (% full adherence to [a] all prioritized recommendations, [b] >75% of prioritized recommendations, and [c] ≥1 prioritized recommendation at 3 and 6 months) and (iv) sustained linkages to community agencies to provide ADL and IADL support (number of participants with linkages to [a] all community agencies, [b] ≥1 community agency at 3 and 6 months).
6 secondary outcomes
Quality of Life
Time frame: 3 and 6 months
Proportion of IADLs being completed independently or with support
Time frame: 3 and 6 months
Emergency department visit rate
Time frame: 3 and 6 months
Hospitalization rate
Time frame: 3 and 6 months
Long-term care home admission rate
Time frame: 3 and 6 months
Length of hospitalization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Older Adults
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive geriatric service worker model of care and Information brochure and telephone follow-up support in people with Older Adults and Social Isolation, run by Unity Health Toronto.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Watt (1+416-864-5015, jennifer.watt@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Feasibility (time frame: Between 3 months to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.