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Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients (DIAPASON)

This study has been completed.
Sponsor:
Collaborators:
Direction de l’Hospitalisation et de l’Organisation des Soins (PREQHOS)
Fondation Médéric Alzheimer
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01430286
First received: August 22, 2011
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.


Condition Intervention
Caregivers
Alzheimer Disease,
Psycho-educational Web-based Program,
Stress,
Self-efficacy,
Burden.
Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason.
Behavioral: Consultation in memory clinic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Perceived stress [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
    Stress perceived by the caregiver is measured by the French version of the Perceived Stress Scale, the version of 14 items from Cohen and colleagues (1983), traduced to by Bruchon-Schweitzer in 2002. The PSS-14 is a widely used self-reported scale, evaluating the general appraisal of stress in the last month. It consists in 14 items, which scores range from 0 (never) to 4 (very often). This scale has demonstrated a high reliability and validity in several studies. The total score range is 0-56. In this study CG and EC will perform the scale at baseline (month 0), at the end of intervention for EC (month 3) and follow-up (month 6). Participants from control group will receive an acces to the program at the end of the last visit (M6).


Secondary Outcome Measures:
  • Nottingham Health Profile (NPH) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
  • ZARIT Burden Interview (BI) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
  • Revised Memory and Behavior Problems Checklist (RMBPC) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI-2) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
  • Revised Scale for Caregiving Self-Efficacy (RCSE) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psycho-educational program
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason.
This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Other Name: Web-based psycho-educational program
Active Comparator: Standard treatment
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
Behavioral: Consultation in memory clinic
This group will receive treatment as usual (consultation in memory clinic every 6 months)
Other Name: Consultation in memory clinic

Detailed Description:

Context: Since some of the ICs do not have the possibility to participate in face-to-face interventions, information and communication technologies are being increasingly used for a distance intervention. Research showing the benefit of a combined approach including psycho-social interventions for caregivers and Information and Communication Technologies (ICT) in the caring of Alzheimer's disease patients is actually growing. Main objective: To evaluate the efficacy of a a web-based psycho-educational program designed to support carers of AD patientsMethodology: This is a randomized clinical trial . 80 participants will be randomized in 2 parallel groups: The volunteers in the experimental condition (EC) should visit at least one time per week the website of program, during 12 weeks. Each week a new thematic is added to the website. b) The participants in the control group (CG) will receive a minimal intervention, and will have access to the Diapason program after their participation (six months). Caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory center participating in the trial.

Evaluation criteria:

Primary criteria:

- Perceived Stress Scale (PSS-14).

Secondary evaluation criteria:

  • Nottingham Health Profile (NPH),
  • Zarit Burden Interview (BI),
  • Revised Memory and Behavior Problems Checklist (RMBPC),
  • Beck Depression Inventory (BDI-2) Mediator variables
  • Revised Scale for Caregiving Self-Efficacy (RCSE).
  • Statistics of website utilization Controlled variables
  • Sociodemographic variables (Self report)
  • Knowledge about illness (Visual analogical scale - VAS)
  • The quality of the relationship with the patient (VAS)
  • Time spent on caregiving
  • Other sources of stress (i.e. work, health status, financial status)
  • Respite or social help (i.e. psychotherapy, associations, technical help, etc)
  • Cognitive and autonomy status of patient (MMSE and IADL)

Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Family caregivers of AD patients DSM IV-TR (American Psychiatric Association 2004) or NINCDS/ADRDA (McKhann et al. 1984).
  • Age: over 18 years old
  • score 12 or over on the Perceived Stress Scale 14 items (PSS-14, Cohen) Need for information or help
  • Sign informed consent

Exclusion criteria :

  • Professional or paid caregiver
  • Physical or mental disease incompatible with patient's management
  • Impossibility to participate in the educational program
  • Absence of perceived stress
  • Ongoing psychotherapy or a similar program in parallel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430286

Locations
France
Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Direction de l’Hospitalisation et de l’Organisation des Soins (PREQHOS)
Fondation Médéric Alzheimer
Investigators
Principal Investigator: Anne-Sophie Rigaud, MD, PhD Hôpital Broca - la Collégiale, Memory Clinic
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01430286     History of Changes
Other Study ID Numbers: P081002
Study First Received: August 22, 2011
Last Updated: July 25, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Caregivers
Alzheimer Disease
Psychological stress
Psychological adaptation
Self-efficacy
Randomized controlled trial

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014