Subjects Aged 75 Years or More Living at HomeFrailcoachNCT04237077
Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home
A study testing telephone coaching program and no telephone coaching program in people with Subjects Aged 75 Years or More Living at Home, run by CHU de Reims at 1 site in France.
Trial summary
Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects Aged 75 Years or More Living at Home
- What is being tested?
- telephone coaching program and no telephone coaching program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2020to 25 Mar 2024
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- subjects aged 75 years or more
- subjects living at home
- subjects able to use phone
- subjects agree to participate to the study
Who cannot join
- subjects do not speak French
Trial locations and contacts
1 site in 1 country.
About this study
Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.
Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".
Read the detailed description
The aim of the study will be evaluate impact of a telephone coaching program on evolution of autonomy in subjects aged 75 years or more living at home
- Being tested
- telephone coaching program, no telephone coaching program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone coaching programOther
telephone coaching program : 7 phone calls by nurse
no telephone coaching programOther
no telephone coaching program : 7 phone calls by nurse
| Study group | Role | What they receive |
|---|---|---|
| Group "with telephone coaching program ". | Experimental | subjects aged 75 years or more living at home, with telephone coaching program Receives: Other: telephone coaching program |
| Group "without telephone coaching program". | Active comparator | subjects aged 75 years or more living at home, without telephone coaching program Receives: Other: no telephone coaching program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomy evolution
Evolution of autonomy score between inclusion and 12 months follow up. The autonomy score (on 14 points) is the sum of the Katz's Activities of Daily Living (on 6 points) and the Lawton's Instrumental Activities of Daily Living (on 8 points).
Katz's Activities of Daily Living comprises 6 items (bathing, dressing, transferring, using the toilet, eating, continence).
Lawton's Instrumental Activities of Daily comprises 8 items (ability to use the telephone, do the shopping, meal preparation, do the housework, do the laundry, use public transport, take responsibility for own medication and manage a budget.)
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 posted22 Jan 2020
- Study start10 Mar 2020
- Primary completion11 Jun 2021
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects Aged 75 Years or More Living at HomeStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237077
- Sponsor's protocol ID
- PO19126*
- Acronym
- Frailcoach
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2020
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home
- ClinicalTrials.gov ID
- NCT04237077
- Acronym / sponsor ID
- Frailcoach / PO19126*
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 22 Jan 2020 (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.
Since the last few decades, developed societies have been evolving towards a global aging of their populations. This evolution has been accompanied by the problematic of the dependence of aging populations. Dependence is today a challenge posed to social, healthcare or medico-social organizations.
Many studies have shown the positive effect of changes in health (physical activity, nutrition, socialization) on functional abilities of aged subjects. Intervention at subject's home is an easy and inexpensive way to delay the onset of dependence in the elderly population. Health coaching is defined as "a regular series of phone calls between the patient and the health care professional to support and encourage the patient and promote healthy behaviors such as treatment control, healthy eating and physical activity ".
Detailed description
The aim of the study will be evaluate impact of a telephone coaching program on evolution of autonomy in subjects aged 75 years or more living at home
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "with telephone coaching program ". | Experimental | Other: telephone coaching programsubjects aged 75 years or more living at home, with telephone coaching program |
| Group "without telephone coaching program". | Active comparator | Other: no telephone coaching programsubjects aged 75 years or more living at home, without telephone coaching program |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- subjects aged 75 years or more
- subjects living at home
- subjects able to use phone
- subjects agree to participate to the study
Key exclusion criteria (1 listed)
- subjects do not speak French
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 |
|---|---|---|
| telephone coaching programtelephone coaching program : 7 phone calls by nurse | Other | Group "with telephone coaching program ". |
| no telephone coaching programno telephone coaching program : 7 phone calls by nurse | Other | Group "without telephone coaching program". |
Primary outcome
Autonomy evolution
Time frame: 12 months
Evolution of autonomy score between inclusion and 12 months follow up. The autonomy score (on 14 points) is the sum of the Katz's Activities of Daily Living (on 6 points) and the Lawton's Instrumental Activities of Daily Living (on 8 points). Katz's Activities of Daily Living comprises 6 items (bathing, dressing, transferring, using the toilet, eating, continence). Lawton's Instrumental Activities of Daily comprises 8 items (ability to use the telephone, do the shopping, meal preparation, do the housework, do the laundry, use public transport, take responsibility for own medication and manage a budget.)
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 26 Mar 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telephone coaching program and no telephone coaching program in people with Subjects Aged 75 Years or More Living at Home, run by CHU de Reims at 1 site in France.
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 26 Mar 2024. 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 France. 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?
Autonomy evolution (time frame: 12 months). 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 26 Mar 2024.