Chronic Conditions, MultipleConvoyPalNCT04779931
Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
A study testing Convoy-Pal in people with Chronic Conditions, Multiple, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Conditions, Multiple
- What is being tested?
- Convoy-Pal
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 May 2023
- 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
- ≥65 years of age
- self-report diagnosis of heart failure (HF)
- have multiple chronic conditions (MCC) based on the Disease Burden/Morbidity Assessment by Self-Report (Individuals will be eligible if they self-report the number of diagnosis > 2 and a disease burden score >2 indicating the presence of at least two chronic conditions that limit activities of daily of living)
- community dwelling in the United States
- English speaking
Who cannot join
- Self-reported diagnosis of Alzheimer's disease or dementia
- Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
- Participation in community-based palliative care in the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
The aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Feasibility will be assessed by recruitment, attrition, and data collection on measures of quality of life and social support. Usability will be captured by self-report usability scales and actual back end utilization data.
- Conditions
- Chronic Conditions, Multiple
- Being tested
- Convoy-Pal
- Medical subject headings
- Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convoy-PalBehavioural
12 week mobile self-management intervention with palliative care resources.
| Study group | Role | What they receive |
|---|---|---|
| Convoy-Pal Intervention | Experimental | Intervention participants will be sent Convoy-Pal equipment and materials. The equipment can simply be removed from the box, plugged in, and turned on to start. Research staff will provide technical support as needed during the trial. Convoy-Pal is 12-week intervention that uses the Routinify platform to deliver self-management tools and palliative care resources in the participants' home. The platform includes a tablet, charging stand, and smart watch, with additional options for mobile phone access and a website portal. Receives: Behavioral: Convoy-Pal |
| Waitlist Control | Active comparator | Participants will complete baseline assessments and will be recontacted at 11 weeks to complete follow up assessments at week 12. Participants will receive a $25 gift card for each assessment ($50 total). If they would like to try the intervention at that time, we will send them Convoy-Pal equipment and materials. They will then have 12 weeks to use the tool. Receives: Behavioral: Convoy-Pal |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Mobile Application Rating Scale
Usability; 20 items; Range 0-25, Higher score indicates better usability
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Apr 2021
- Primary completion30 May 2023
- Study completion30 May 2023
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 Chronic Conditions, MultipleStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer D Portz, PhD, MSW, Principal investigator, University of Colorado Denver | Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779931
- Sponsor's protocol ID
- 18-0973
- Other IDs
- K76AG059934
- Acronym
- ConvoyPal
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeGroot L, Gillette R, Villalobos JP, Harger G, Doyle DT, Bull S, Bekelman DB, Boxer R, Kutner JS, Portz JD. Feasibility of a digital palliative care intervention (Convoy-Pal) for older adults with heart failure and multiple chronic conditions and their caregivers: a waitlist randomized control trial. BMC Palliat Care. 2024 Oct 1;23(1):234. doi: 10.1186/s12904-024-01561-w.
PubMed 39354453
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usability and Feasibility of Social Convoy Palliative Care (Convoy-Pal) Mobile Health for Older Adults
- ClinicalTrials.gov ID
- NCT04779931
- Acronym / sponsor ID
- ConvoyPal / 18-0973
- Conditions
- Chronic Conditions, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Mar 2021 (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 aim of this study is to test the feasibility and usability of the Convoy-Pal mobile intervention among older adults. The study is a pilot waitlist control RCT with 40 patients and their convoys randomized to one of two arms: Convoy-Pal intervention or waitlist control. Feasibility will be assessed by recruitment, attrition, and data collection on measures of quality of life and social support. Usability will be captured by self-report usability scales and actual back end utilization data.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convoy-Pal Intervention | Experimental | Behavioral: Convoy-PalIntervention participants will be sent Convoy-Pal equipment and materials. The equipment can simply be removed from the box, plugged in, and turned on to start. Research staff will provide technical support as needed during the trial. Convoy-Pal is 12-week intervention that uses the Routinify platform to deliver self-management tools and palliative care resources in the participants' home. The platform includes a tablet, charging stand, and smart watch, with additional options for mobile phone access and a website portal. |
| Waitlist Control | Active comparator | Behavioral: Convoy-PalParticipants will complete baseline assessments and will be recontacted at 11 weeks to complete follow up assessments at week 12. Participants will receive a $25 gift card for each assessment ($50 total). If they would like to try the intervention at that time, we will send them Convoy-Pal equipment and materials. They will then have 12 weeks to use the tool. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥65 years of age
- self-report diagnosis of heart failure (HF)
- have multiple chronic conditions (MCC) based on the Disease Burden/Morbidity Assessment by Self-Report (Individuals will be eligible if they self-report the number of diagnosis > 2 and a disease burden score >2 indicating the presence of at least two chronic conditions that limit activities of daily of living)
- community dwelling in the United States
- English speaking
Key exclusion criteria (3 listed)
- Self-reported diagnosis of Alzheimer's disease or dementia
- Self-reported diagnosis of a severe mental health problem (e.g. schizophrenia, bipolar affective disorder or other psychotic illness)
- Participation in community-based palliative care in the last 12 months
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 |
|---|---|---|
| Convoy-Pal12 week mobile self-management intervention with palliative care resources. | Behavioural | Convoy-Pal Intervention, Waitlist Control |
Primary outcome
User Mobile Application Rating Scale
Time frame: 12 weeks
Usability; 20 items; Range 0-25, Higher score indicates better usability
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 18 Jun 2023.
- Derived from this study: PubMed 39354453DeGroot L, Gillette R, Villalobos JP, Harger G, Doyle DT, Bull S, Bekelman DB, Boxer R, Kutner JS, Portz JD. Feasibility of a digital palliative care intervention (Convoy-Pal) for older adults with heart failure and multiple chronic conditions and their caregivers: a waitlist randomized control trial. BMC Palliat Care. 2024 Oct 1;23(1):234. doi: 10.1186/s12904-024-01561-w.
- 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.
Jennifer D Portz, PhD, MSW principal investigator
University of Colorado Denver | Anschutz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convoy-Pal in people with Chronic Conditions, Multiple, run by University of Colorado, Denver at 1 site in United States.
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 5 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 18 Jun 2023. 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 United States. 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?
User Mobile Application Rating Scale (time frame: 12 weeks). 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 NCT04779931, 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 18 Jun 2023.