Alzheimer DiseaseTHERADNCT01796314
Impact of Therapeutic Educational Programme on the Alzheimer's Disease Affected Patient's Quality of Life
A study testing Therapeutic Educational Program in people with Alzheimer Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Therapeutic Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Feb 2017
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26)
- in community dwelling
- with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week)
- is informed and has given his/her consent
- whom caregiver is informed and has given his/her consent
Who cannot join
- patient with other type of dementia
- living in nursing home or long term care
- with no caregiver
- not informed or has not given his/her consent
- whom caregiver is not informed or has not given his/her consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life
Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.
Read the detailed description
This study is designed to determine whether a therapeutic educational programme for both AD patients, in community dwelling, and their primary caregivers improves patient's quality of life, after two months.
Design : This study is a monocentric randomised controlled intervention trial
Population : One hundred and seventy dyads 'patient-caregiver' in which the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), lives in community dwelling and has a primary caregiver will be included during eighteen months. The primary caregiver is define as a person living with the patient or providing care at least 3 times a week or 8 hours per week; he/she isn't a professional. Eighty five dyad will be include in the intervention group (group A) and eighty five in the control group (group B).
Outcome : Our primary endpoint is the AD patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (Qol-AD) reported by the caregiver at two months.
Our secondary endpoints are caregiver's burden assessed by the Zarit Burden Inventory, frequency and severity of behavioural and psychological symptoms assessed by the Neuro Psychiatric Inventory, independence in personal and instrumental daily life activities assessed by Katz's Activities of Daily Living and Lawton's Instrumental Activities of Daily Living scales, and caregiver's quality of life assessed by the Nottingham Health Profile at 6 months. The patient quality of life will also be recorded at 12 months on the logsdon's Quality of Life in Alzheimer's Disease scale reported, and at every visit (MO, M2, M6, et M12) on the same scale dut (QoL-AD) reported by the patient himself.
Intervention :
The intervention is a therapeutic educational programme. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months.
The intervention group (n=85) will benefit from an educational programme that includes two consultations for the dyad AD patient/caregiver and four group sessions for caregivers only. The two consultations will be held at baseline (MO) and two months later (M2); the first one (MO)will include : the 'educational diagnosis', the comprehensive assessment of the patient and assessment of the judgement criteria. Between MO and M2 the primary caregivers will participate to four collective sessions one per week about, of 3 hours length : 1- Knowledge of the disease; 2- Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia 3- Crisis situations. Prevention of caregiver's exhaustion 4- Assistive devices and care pathways. At M2, the dyad will benefit from : assessment of response to the educational objectives and of the judgement criteria.
The control group (n=85) will benefit from routine care.
The intervention will be implemented over an eighteen month period.
Monitoring will consist of a two consultations to 6 and 12 months including assessment of primary and secondary judgment criteria.
Data collection :
Data will be collected in Access data basis and SAS software will be used to perform statistic analysis. Intention to treat analysis using linear mixed model will be performed, adjusting for patient (disease severity), caregiver characteristics (burden) and occurence of life event that may interfere with the patient's quality of life.
- Conditions
- Alzheimer Disease
- Being tested
- Therapeutic Educational Program
- Keywords
- Therapeutic educational programme for Alzheimer's disease patients and their caregiver, Alzheimer's disease, mild to moderately severe stages, Community dwelling patients with family caregiver, quality of life
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Educational ProgramBehavioural
Also called Therapeutic education programme
The intervention is a therapeutic educational programme as recommended in the care of Alzheimer's disease. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months.
These collective sessions focus on :
- Knowledge of the disease
- Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia
- Crisis situations. Prevention of caregiver's exhaustion
- Assistive devices and care pathways.
Monitoring will consist of a two consultations to 6 and 12 months including assessment of secondary outcome measures.
| Study group | Role | What they receive |
|---|---|---|
| Group A : intervention | Experimental | 85 dyads "patient/caregiver" in witch the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), and lives at home with a caregiver Receives: Behavioral: Therapeutic Educational Program |
| Group B : Control | No intervention | There si no associated intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease patient's quality of life
Alzheimer's Disease patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (QoL-AD) reported by the caregiver
Measured: 2 months
Secondary outcomes (1)
Caregiver quality of life
- Caregiver's burden assessed by the Zarit Burden Inventory
- Frequency and severity of behavioural and psychological symptoms assessed by the Neuro Psychiatric inventory
- Independence in personal and instrumental daily life activities assessed by Katz's Activities of Daily Living and Lawton's Instrumental Activities of Daily Living scales
- Caregiver's quality of life assessed by the Nottingham Health Profile at 6 months
- Patient quality of life at 6 and 12 months on the Logsdon's Quality of Life in Alzheimer's Disease scale reported by the caregiver
- Patient quality of life at 2,6 and 12 months on the Logsdon's Quality of Life in Alzheimer's Disease scale reported by the patient himself
Measured: 2, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University Hospital, ToulouseThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène VILLARS, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796314
- Sponsor's protocol ID
- RC31/11/255
- Other IDs
- PREQHOS n°11 255 07
- Acronym
- THERAD
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2013
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Villars H, Gardette V, Perrin A, Hein C, Elmalem S, de Peretti E, Zueras A, Vellas B, Nourhashemi F. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life. Alzheimers Res Ther. 2014 Oct 27;6(5-8):66. doi: 10.1186/s13195-014-0066-1. eCollection 2014.
PubMed 25478028Villars H, Cantet C, de Peretti E, Perrin A, Soto-Martin M, Gardette V. Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD. Alzheimers Res Ther. 2021 Sep 12;13(1):152. doi: 10.1186/s13195-021-00896-3.
PubMed 34511121
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Therapeutic Educational Programme for Alzheimer's Disease Patients and Their Caregiver in Community Dwelling, on the AD Patient's Quality of Life
- ClinicalTrials.gov ID
- NCT01796314
- Acronym / sponsor ID
- THERAD / RC31/11/255
- Conditions
- Alzheimer Disease
- Keywords
- Therapeutic educational programme for Alzheimer's disease patients and their caregiver, Alzheimer's disease, mild to moderately severe stages, Community dwelling patients with family caregiver, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Feb 2013 (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.
Therapeutic education expands in Alzheimer's Disease management in France. Several studies revealed a positive impact on caregiver's burden and/or quality of life. The purpose of this study, is to determine whether a therapeutic educational programme for both AD patients and primary caregivers, in community dwelling, improves patient's quality of life.
Detailed description
This study is designed to determine whether a therapeutic educational programme for both AD patients, in community dwelling, and their primary caregivers improves patient's quality of life, after two months.
Design : This study is a monocentric randomised controlled intervention trial
Population : One hundred and seventy dyads 'patient-caregiver' in which the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), lives in community dwelling and has a primary caregiver will be included during eighteen months. The primary caregiver is define as a person living with the patient or providing care at least 3 times a week or 8 hours per week; he/she isn't a professional. Eighty five dyad will be include in the intervention group (group A) and eighty five in the control group (group B).
Outcome : Our primary endpoint is the AD patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (Qol-AD) reported by the caregiver at two months.
Our secondary endpoints are caregiver's burden assessed by the Zarit Burden Inventory, frequency and severity of behavioural and psychological symptoms assessed by the Neuro Psychiatric Inventory, independence in personal and instrumental daily life activities assessed by Katz's Activities of Daily Living and Lawton's Instrumental Activities of Daily Living scales, and caregiver's quality of life assessed by the Nottingham Health Profile at 6 months. The patient quality of life will also be recorded at 12 months on the logsdon's Quality of Life in Alzheimer's Disease scale reported, and at every visit (MO, M2, M6, et M12) on the same scale dut (QoL-AD) reported by the patient himself.
Intervention :
The intervention is a therapeutic educational programme. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months.
The intervention group (n=85) will benefit from an educational programme that includes two consultations for the dyad AD patient/caregiver and four group sessions for caregivers only. The two consultations will be held at baseline (MO) and two months later (M2); the first one (MO)will include : the 'educational diagnosis', the comprehensive assessment of the patient and assessment of the judgement criteria. Between MO and M2 the primary caregivers will participate to four collective sessions one per week about, of 3 hours length : 1- Knowledge of the disease; 2- Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia 3- Crisis situations. Prevention of caregiver's exhaustion 4- Assistive devices and care pathways. At M2, the dyad will benefit from : assessment of response to the educational objectives and of the judgement criteria.
The control group (n=85) will benefit from routine care.
The intervention will be implemented over an eighteen month period.
Monitoring will consist of a two consultations to 6 and 12 months including assessment of primary and secondary judgment criteria.
Data collection :
Data will be collected in Access data basis and SAS software will be used to perform statistic analysis. Intention to treat analysis using linear mixed model will be performed, adjusting for patient (disease severity), caregiver characteristics (burden) and occurence of life event that may interfere with the patient's quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : intervention | Experimental | Behavioral: Therapeutic Educational Program85 dyads "patient/caregiver" in witch the patient suffers from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26), and lives at home with a caregiver |
| Group B : Control | No intervention | –There si no associated intervention |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient suffering from mild to moderately severe Alzheimer's disease patients (MMSE 11 to 26)
- in community dwelling
- with an informal caregiver (person living with the patient or providing care 3 times a week or 8 hours per week)
- is informed and has given his/her consent
- whom caregiver is informed and has given his/her consent
Key exclusion criteria (5 listed)
- patient with other type of dementia
- living in nursing home or long term care
- with no caregiver
- not informed or has not given his/her consent
- whom caregiver is not informed or has not given his/her consent
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 |
|---|---|---|
| Therapeutic Educational ProgramAlso: Therapeutic education programmeThe intervention is a therapeutic educational programme as recommended in the care of Alzheimer's disease. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months. These collective sessions focus on : 1. Knowledge of the disease 2. Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia 3. Crisis situations. Prevention of caregiver's exhaustion 4. Assistive devices and care pathways. Monitoring will consist of a two consultations to 6 and 12 months including assessment of secondary outcome measures. | Behavioural | Group A : intervention |
Primary outcome
Alzheimer's Disease patient's quality of life
Time frame: 2 months
Alzheimer's Disease patient's quality of life assessed by Logsdon's Quality of life in Alzheimer's Disease scale (QoL-AD) reported by the caregiver
1 secondary outcome
Caregiver quality of life
Time frame: 2, 6 and 12 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 Oct 2026.
- Background: PubMed 25478028Villars H, Gardette V, Perrin A, Hein C, Elmalem S, de Peretti E, Zueras A, Vellas B, Nourhashemi F. Study protocol: Randomised controlled trial to evaluate the impact of an educational programme on Alzheimer's disease patients' quality of life. Alzheimers Res Ther. 2014 Oct 27;6(5-8):66. doi: 10.1186/s13195-014-0066-1. eCollection 2014.
- Results publication: PubMed 34511121Villars H, Cantet C, de Peretti E, Perrin A, Soto-Martin M, Gardette V. Impact of an educational programme on Alzheimer's disease patients' quality of life: results of the randomized controlled trial THERAD. Alzheimers Res Ther. 2021 Sep 12;13(1):152. doi: 10.1186/s13195-021-00896-3.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Hélène VILLARS, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Educational Program in people with Alzheimer Disease, run by University Hospital, Toulouse 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 5 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 Oct 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?
Alzheimer's Disease patient's quality of life (time frame: 2 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 NCT01796314, which also lists 2 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 Oct 2026.