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Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home (Frailcoach)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04237077
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief 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.

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 ".


Condition or disease Intervention/treatment Phase
Subjects Aged 75 Years or More Living at Home Other: telephone coaching program Other: no telephone coaching program Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome Assessor will be blinded
Primary Purpose: Prevention
Official Title: Impact of a Telephone Coaching Program on Evolution of Autonomy in Subjects Aged 75 Years or More Living at Home
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Arm Intervention/treatment
Experimental: Group "with telephone coaching program ".
subjects aged 75 years or more living at home, with telephone coaching program
Other: 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
Other: no telephone coaching program
no telephone coaching program : 7 phone calls by nurse




Primary Outcome Measures :
  1. 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.)




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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237077


Contacts
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Contact: Jean-Luc NOVELLA 3 26 78 83 40 ext 0033 jlnovella@chu-reims.fr

Locations
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France
Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT04237077    
Other Study ID Numbers: PO19126*
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No