Alzheimer's DiseaseIADLNCT02654574
Comparison of Two Modes of Administration of the IADL Questionnaire, Assessing the Level of Functional Autonomy of Patients to Carry Out the Tasks of Daily Living: Randomized Controlled Trial Among Patients of a Memory Clinic
A study testing IADL administration by phone in people with Alzheimer's Disease and Dementia Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In France, about 1 million people 65 and older are diagnosed with dementia syndrome characterized by cognitive decline and impairment of functional capacity. The assessment of the level of functional autonomy is therefore an essential step in monitoring patients in Memory Clinic and can be estimated by the Lawton IADL… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Dementia Disorders
- What is being tested?
- IADL administration by phone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Apr 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received for the first time at the Memory Clinic,
- Patients living at home
- Patients accompanied by a caregiver,
- Patients and caregivers agreeing to participate in the study.
Who cannot join
- Patients whose caregivers did not wish to participate in the study,
- Patients living in institutions or nursing homes,
- Patients whose caregivers did not have or did not provide a telephone contact,
- Patients for who the health status would require institutionalization during the period of the study.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Charpennes - Memory Research Centre Lyon, Clinical Research Centre (CVF)
Villeurbanne, 69100
About this study
Official title: Comparison of Two Modes of Administration of the IADL Questionnaire
In France, about 1 million people 65 and older are diagnosed with dementia syndrome characterized by cognitive decline and impairment of functional capacity. The assessment of the level of functional autonomy is therefore an essential step in monitoring patients in Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients' ability to perform daily tasks.
In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during a face-to-face interview between their primary caregiver and a nurse, using the IADL questionnaire. This assessment should be renewed every year. The IADL questionnaire is part of the information that the memories consultations shall transmit to the Alzheimer's National Bank (BNA).
Read more
However, current practice has shown that the systematic collection is problematic in the organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in order to measure changes in the level of autonomy during the disease, and improve the completeness of this collection. A study is conducted with the main objective to measure the reliability of the assessment of IADL questionnaires conducted during a telephone interview with the caregiver of the patient, in comparison to the reference mode: the face-to-face interview with the caregiver.
Materials and methods The experimental design of the study will be a randomized crossover trial (crossover), including 394 patients divided into two branches. In the first part, the collection of the IADL questionnaire will be performed according to the reference method in the consultation (face-to-face interview with the nurse), the measurement will be repeated at 1 month intervals by phone. In the second part the sequence of execution modes will be reversed. The reliability of the measurement of the level of autonomy will be studied by comparing repeated measurements based on handover modes. The correspondence between the repeated measures will also be considered in terms of patient characteristics. The feasibility of administration of the questionnaire by phone mode will be evaluated.
Expected results The mode of administration by phone should allow to obtain a reliable measurement of the level of patient autonomy when the administration is carried out in a standardized way. The study should also identify patients and situations for which this method of administration by phone may be appropriate.
- Conditions
- Alzheimer's Disease, Dementia Disorders
- Being tested
- IADL administration by phone
- Keywords
- Alzheimer's disease or related disorders, Functional autonomy level, Lawton Instrumental Activities of Daily Living, The Functional autonomy level
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IADL administration by phoneOther
The administration of IADL questionnaire by phone consists of a collection of answers given by the caregiver during the interview with the research nurse, trained for this procedure. This method of procurement will be standardized with a listing support for the phone interview to obtain the same conditions for collection of data from a caregiver to another. Questions will be asked in the same order than the questionnaire collected with the reference procedure i.e. face-to-face interview at the Memory Clinic. The IADL questionnaires in paper format used during the ace-to-face interview and by phone will be identical.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face collection followed by collection by phone | Experimental | Reference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, followed by the collection of IADL by phone, one month later. Receives: Other: IADL administration by phone |
| Collection by phone followed by face-to-face collection | Experimental | Collection of IADL by phone, followed by the collection of the IADL questionnaire using the reference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, one month later. Receives: Other: IADL administration by phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone)
The degree of agreement (concordance) of the overall level of autonomy will be measured between the two modes administration of the IADL questionnaire.
The level of independence (or dependence) will be evaluated from the scale of instrumental activities of daily living (IADL Lawton). From 8 issues, it allows to study the ability of the person to perform common activities: Ability to use the phone to go shopping, preparing food, do its housekeeping, to its activities bleaching, to use the means of transport, to ensure accountability in respect of salary and handle money.
Measured: 1 month
Secondary outcomes (1)
Consistency of the answers to each question of the IADL questionnaires between the two methods of administration
To assess the reliability of the collection of the questionnaire by phone (agreement answers to each question on the IADL), the secondary endpoint will be considered:
- The consistency of the answers to each question of the IADL questionnaires between the two methods of administration: during the face-to-face interview, and by phone.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654574
- Sponsor's protocol ID
- 2014-867
- Other IDs
- 2014-A00446-41
- Acronym
- IADL
- Status last verified
- Aug 2025
- First submitted
- 11 Jan 2016
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dauphinot V, Boublay N, Moutet C, Achi S, Bathsavanis A, Krolak-Salmon P. Comparison of Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews: a randomized, crossover study. Alzheimers Res Ther. 2020 Mar 13;12(1):24. doi: 10.1186/s13195-020-00590-w.
PubMed 32169093
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Modes of Administration of the IADL Questionnaire
- ClinicalTrials.gov ID
- NCT02654574
- Acronym / sponsor ID
- IADL / 2014-867
- Conditions
- Alzheimer's Disease, Dementia Disorders
- Keywords
- Alzheimer's disease or related disorders, Functional autonomy level, Lawton Instrumental Activities of Daily Living, The Functional autonomy level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jan 2016 (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.
In France, about 1 million people 65 and older are diagnosed with dementia syndrome characterized by cognitive decline and impairment of functional capacity. The assessment of the level of functional autonomy is therefore an essential step in monitoring patients in Memory Clinic and can be estimated by the Lawton IADL questionnaire, assessing the patients' ability to perform daily tasks.
In the Memory Clinic, the first estimate of the level of patient autonomy is achieved during a face-to-face interview between their primary caregiver and a nurse, using the IADL questionnaire. This assessment should be renewed every year. The IADL questionnaire is part of the information that the memories consultations shall transmit to the Alzheimer's National Bank (BNA).
However, current practice has shown that the systematic collection is problematic in the organization of Memory Clinic. It is thus expected to collect this questionnaire by phone in order to measure changes in the level of autonomy during the disease, and improve the completeness of this collection. A study is conducted with the main objective to measure the reliability of the assessment of IADL questionnaires conducted during a telephone interview with the caregiver of the patient, in comparison to the reference mode: the face-to-face interview with the caregiver.
Materials and methods The experimental design of the study will be a randomized crossover trial (crossover), including 394 patients divided into two branches. In the first part, the collection of the IADL questionnaire will be performed according to the reference method in the consultation (face-to-face interview with the nurse), the measurement will be repeated at 1 month intervals by phone. In the second part the sequence of execution modes will be reversed. The reliability of the measurement of the level of autonomy will be studied by comparing repeated measurements based on handover modes. The correspondence between the repeated measures will also be considered in terms of patient characteristics. The feasibility of administration of the questionnaire by phone mode will be evaluated.
Expected results The mode of administration by phone should allow to obtain a reliable measurement of the level of patient autonomy when the administration is carried out in a standardized way. The study should also identify patients and situations for which this method of administration by phone may be appropriate.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face collection followed by collection by phone | Experimental | Other: IADL administration by phoneReference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, followed by the collection of IADL by phone, one month later. |
| Collection by phone followed by face-to-face collection | Experimental | Other: IADL administration by phoneCollection of IADL by phone, followed by the collection of the IADL questionnaire using the reference procedure i.e IADL collected during a face-to-face interview at the Memory Clinic, one month later. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients received for the first time at the Memory Clinic,
- Patients living at home
- Patients accompanied by a caregiver,
- Patients and caregivers agreeing to participate in the study.
Key exclusion criteria (4 listed)
- Patients whose caregivers did not wish to participate in the study,
- Patients living in institutions or nursing homes,
- Patients whose caregivers did not have or did not provide a telephone contact,
- Patients for who the health status would require institutionalization during the period of the study.
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 |
|---|---|---|
| IADL administration by phoneThe administration of IADL questionnaire by phone consists of a collection of answers given by the caregiver during the interview with the research nurse, trained for this procedure. This method of procurement will be standardized with a listing support for the phone interview to obtain the same conditions for collection of data from a caregiver to another. Questions will be asked in the same order than the questionnaire collected with the reference procedure i.e. face-to-face interview at the Memory Clinic. The IADL questionnaires in paper format used during the ace-to-face interview and by phone will be identical. | Other | Collection by phone followed by face-to-face collection, Face-to-face collection followed by collection by phone |
Primary outcome
Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone)
Time frame: 1 month
The degree of agreement (concordance) of the overall level of autonomy will be measured between the two modes administration of the IADL questionnaire. The level of independence (or dependence) will be evaluated from the scale of instrumental activities of daily living (IADL Lawton). From 8 issues, it allows to study the ability of the person to perform common activities: Ability to use the phone to go shopping, preparing food, do its housekeeping, to its activities bleaching, to use the means of transport, to ensure accountability in respect of salary and handle money.
1 secondary outcome
Consistency of the answers to each question of the IADL questionnaires between the two methods of administration
Time frame: 1 month
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 11 Aug 2025.
- Results publication: PubMed 32169093Dauphinot V, Boublay N, Moutet C, Achi S, Bathsavanis A, Krolak-Salmon P. Comparison of Instrumental Activities of Daily Living assessment by face-to-face or telephone interviews: a randomized, crossover study. Alzheimers Res Ther. 2020 Mar 13;12(1):24. doi: 10.1186/s13195-020-00590-w.
Related trials for Alzheimer's 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IADL administration by phone in people with Alzheimer's Disease and Dementia Disorders, run by Hospices Civils de Lyon 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 4 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 11 Aug 2025. 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?
Degree of agreement (concordance) of the overall level of functional autonomy measured with two ways (face-to-face interview and by phone) (time frame: 1 month). 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 NCT02654574, which also lists 1 linked publication.
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 11 Aug 2025.