- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04237077
Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home (Frailcoach)
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 ".
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean-Luc NOVELLA
- Phone Number: 0033 3 26 78 83 40
- Email: jlnovella@chu-reims.fr
Study Locations
-
-
-
Reims, France, 51092
- CHU Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- subjects aged 75 years or more
- subjects living at home
- subjects able to use phone
- subjects agree to participate to the study
Exclusion Criteria:
- subjects do not speak French
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group "with telephone coaching program ".
subjects aged 75 years or more living at home, with telephone coaching program
|
telephone coaching program : 7 phone calls by nurse
|
Active Comparator: Group "without telephone coaching program".
subjects aged 75 years or more living at home, without telephone coaching program
|
no telephone coaching program : 7 phone calls by nurse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.) |
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PO19126*
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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