Alzheimer DiseaseDIAPASONNCT01430286
Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients
A study testing psycho-social intervention based on a web-based psycho-educational program, called Diapason. and Consultation in memory clinic in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- psycho-social intervention based on a web-based psycho-educational program, called Diapason. and Consultation in memory clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jul 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
Paris, 75013
About this study
Official title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- psycho-social intervention based on a web-based psycho-educational program, called Diapason., Consultation in memory clinic
- Keywords
- Caregivers, Alzheimer Disease, Psychological stress, Psychological adaptation, Self-efficacy, Randomized controlled trial
- Medical subject headings
- Alzheimer Disease, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psycho-social intervention based on a web-based psycho-educational program, called Diapason.Behavioural
Also called Web-based psycho-educational program
This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Consultation in memory clinicBehavioural
This group will receive treatment as usual (consultation in memory clinic every 6 months)
| Study group | Role | What they receive |
|---|---|---|
| Psycho-educational program | Experimental | This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc. Receives: Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason. |
| Standard treatment | Active comparator | This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation. Receives: Behavioral: Consultation in memory clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
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).
Measured: every 3 months (between 0 and 6 months)
Secondary outcomes (5)
Nottingham Health Profile (NPH)
Measured: every 3 months (between 0 and 6 months)
ZARIT Burden Interview (BI)
Measured: every 3 months (between 0 and 6 months)
Revised Memory and Behavior Problems Checklist (RMBPC)
Measured: every 3 months (between 0 and 6 months)
Beck Depression Inventory (BDI-2)
Measured: every 3 months (between 0 and 6 months)
Revised Scale for Caregiving Self-Efficacy (RCSE)
Measured: every 3 months (between 0 and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS), Fondation Mederic Alzheimer, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie Rigaud, MD, PhD, Principal investigator, Hôpital Broca - la Collégiale, Memory Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01430286
- Sponsor's protocol ID
- P081002
- Acronym
- DIAPASON
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2011
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.
PubMed 15717336Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. doi: 10.2190/AN6L-6QBQ-76G0-0N9A.
PubMed 8886875Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64. doi: 10.1034/j.1600-0579.2003.00210.x.
PubMed 12752841Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
PubMed 7991117Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Arguelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31. doi: 10.1093/geront/43.4.521.
PubMed 12937331Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. doi: 10.1037/0882-7974.22.1.37.
PubMed 17385981Gottlieb BH, Wolfe J. Coping with family caregiving to persons with dementia: a critical review. Aging Ment Health. 2002 Nov;6(4):325-42. doi: 10.1080/1360786021000006947.
PubMed 12425767Livingston G, Manela M, Katona C. Depression and other psychiatric morbidity in carers of elderly people living at home. BMJ. 1996 Jan 20;312(7024):153-6. doi: 10.1136/bmj.312.7024.153.
PubMed 8563534Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14. doi: 10.1176/appi.ajp.157.5.708.
PubMed 10784462McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
PubMed 6610841Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67. doi: 10.1093/geront/43.4.556.
PubMed 12937334Magnusson L, Hanson E, Brito L, Berthold H, Chambers M, Daly T. Supporting family carers through the use of information and communication technology--the EU project ACTION. Int J Nurs Stud. 2002 May;39(4):369-81. doi: 10.1016/s0020-7489(01)00034-7.
PubMed 11909614Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34. doi: 10.1093/geronb/59.1.p27.
PubMed 14722336
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
- ClinicalTrials.gov ID
- NCT01430286
- Acronym / sponsor ID
- DIAPASON / P081002
- Conditions
- Alzheimer Disease
- Keywords
- Caregivers, Alzheimer Disease, Psychological stress, Psychological adaptation, Self-efficacy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS), Fondation Mederic Alzheimer, URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Sep 2011 (estimated)
- 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 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psycho-educational program | Experimental | Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason.This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc. |
| Standard treatment | Active comparator | Behavioral: Consultation in memory clinicThis group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| psycho-social intervention based on a web-based psycho-educational program, called Diapason.Also: Web-based psycho-educational programThis group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc. | Behavioural | Psycho-educational program |
| Consultation in memory clinicThis group will receive treatment as usual (consultation in memory clinic every 6 months) | Behavioural | Standard treatment |
Primary outcome
Perceived stress
Time frame: every 3 months (between 0 and 6 months)
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).
5 secondary outcomes
Nottingham Health Profile (NPH)
Time frame: every 3 months (between 0 and 6 months)
ZARIT Burden Interview (BI)
Time frame: every 3 months (between 0 and 6 months)
Revised Memory and Behavior Problems Checklist (RMBPC)
Time frame: every 3 months (between 0 and 6 months)
Beck Depression Inventory (BDI-2)
Time frame: every 3 months (between 0 and 6 months)
Revised Scale for Caregiving Self-Efficacy (RCSE)
Time frame: every 3 months (between 0 and 6 months)
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 5 Mar 2026.
- Background: PubMed 15717336Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.
- Background: PubMed 11832252Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Background: PubMed 8886875Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. doi: 10.2190/AN6L-6QBQ-76G0-0N9A.
- Background: PubMed 12752841Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64. doi: 10.1034/j.1600-0579.2003.00210.x.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 7991117Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.
- Background: PubMed 12937331Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Arguelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31. doi: 10.1093/geront/43.4.521.
- Background: PubMed 17385981Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. doi: 10.1037/0882-7974.22.1.37.
- Background: PubMed 12425767Gottlieb BH, Wolfe J. Coping with family caregiving to persons with dementia: a critical review. Aging Ment Health. 2002 Nov;6(4):325-42. doi: 10.1080/1360786021000006947.
- Background: PubMed 8563534Livingston G, Manela M, Katona C. Depression and other psychiatric morbidity in carers of elderly people living at home. BMJ. 1996 Jan 20;312(7024):153-6. doi: 10.1136/bmj.312.7024.153.
- Background: PubMed 10784462Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14. doi: 10.1176/appi.ajp.157.5.708.
- Background: PubMed 6610841McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
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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.
Anne-Sophie Rigaud, MD, PhD principal investigator
Hôpital Broca - la Collégiale, Memory Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psycho-social intervention based on a web-based psycho-educational program, called Diapason. and Consultation in memory clinic in people with Alzheimer Disease, run by Assistance Publique - Hôpitaux de Paris 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 5 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 5 Mar 2026. 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?
Perceived stress (time frame: every 3 months (between 0 and 6 months)). 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 NCT01430286, which also lists 29 linked publications.
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 5 Mar 2026.