Alzheimer DiseaseADIANCT03615027
Dementia-specific Intervention of Advance Care Planning
A study testing Dementia-specific advance care planning in people with Alzheimer Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
This is a pilot study that aims to create a dementia-specific intervention of advance care planning (ACP) and test its feasibility and acceptance with min 20 max 30 patient-relative dyads. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Dementia-specific advance care planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Aug 2018to 31 Dec 2019
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients older than 65 years
- Having been diagnosed with an early-stage dementia of Alzheimer's disease aetiology or mixed Alzheimer-vascular aetiology (Montreal cognitive assessement (MoCA) > 20 and Clinical dementia rating (CDR) < 1.5);
- Having been informed about the diagnosis by their treating physician and that are regularly followed by him/her;
- Patient that show interest in advance care planning or advance directives;
- Patients with psychiatric disorders can be included if their psychiatric symptoms are controlled and under the supervision of their psychiatrist at the Unit of psychogeriatric care;
- Retaining full decision-making capacity according to the MoCA > 20 or the clinical judgement a physician or psychologist. During the study, the PI and the facilitators will monitor patient's decision-making capacity clinically;
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- Having the necessary French language competencies to engage in conversations;
- Having a close family caregiver over 18 years old, who is informed about the patient's diagnosis, possesses the before mentioned cognitive and communication skills, and is willingly to participate to this pilot intervention;
- Informed Consent for both members of the dyad as documented by signature;
Who cannot join
- Patients that have a dementia associated with fronto-temporal lobe degeneration;
- Patients that have mild cognitive impairments (MCI);
- Patients that have moderate to severe cognitive disorders, anosognosia or else, assessed clinically or through scales or based on in-person screening, that suggest decision-making capacity may be impaired;
- The patient or her/his caregiver decide to withdraw from the study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Patients that have a dementia associated with fronto-temporal lobe degeneration;
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- Patients that have MCI;
- Patients that have moderate to severe cognitive disorders, anosognosia or else, assessed clinically or through scales or based on in-person screening, that suggest decision-making capacity may be impaired;
- The patient or her/his caregiver decide to withdraw from the study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
Francesca Bosisio, PhD, 213141053 ext. 0041, francesca.bosisio@chuv.ch
Ralf J Jox, MD, PhD, 213145434 ext. 0041, ralf.jox@chuv.ch
About this study
This is a pilot study that aims to create a dementia-specific intervention of advance care planning (ACP) and test its feasibility and acceptance with min 20 max 30 patient-relative dyads.
The intervention is adapted from the Multiprofessional advance care planning and shared decision-making for end of life care (MAPS) Trials 1 and 2 made at the Zurich University Hospital.
The study design is longitudinal (historic): all the dyads will be asked to go through the process (4 visits, see 9.3 Procedures at each visit).
Read the detailed description
Study background and aims:
Advance care planning (ACP) is a structured communication process between an individual, his family, and his healthcare agent (if existing), facilitated by a healthcare provider. The aim is to identify the personal values of the individual, reflect on the meanings and consequences of anticipated illness scenarios, define goals and preferences of care for these situations, issue appropriate documents and legal instruments that will help direct future healthcare decisions, and review these steps at adequate intervals. ACP emphasizes communication in anticipation of a future deterioration of a person's health. Even though dementia entails the loss of decision-making capacity, advance care planning is yet to become widespread. This study aims to close the gap and create a dementia-specific ACP intervention that:
- Support patient autonomy through advance care planning
- Improve participants' satisfaction and perceived control;
- Increase planning decisions and surrogate's knowledge of patients' preferences and values.
Procedure and measure:
Pre-intervention assessment (Visit 1):
If the patient and her/his relative have both consented to the study, the PI will ask the patient and her/his relative to fil out psychometric scales: Hospital anxiety and depression scale (HADS), Decisional conflict scale, Personal autonomy scale and Zarit Burden Inventory. Then, the PI will realize a semi-structured interview on patient's val-ues and treatment preferences and caregiver's knowledge of patient's preferences and care planning decisions that have already been made. Participants will also be asked to hand out a copy of any pre-existing advance directives or other advance care planning document.
Intervention (Visit 2):
In the intervention this first conversation (45-90 min) with a specifically trained ACP facilitator aims to explain the goal and content of ACP and prompt the patient to reflect upon his/her values and preferences for healthcare and discuss them with his/her caregiver. In addition, the written decision aids will be explained and provided to the patient/caregiver to be read at home. At the end of the meeting, the facilitator will ask to set up the second meeting.
Intervention (Visit 3):
The second conversation of the ACP facilitator with the patient and her/his caregiver aims to help the patient to specify her/his preferences and trans-late them into actionable documentation. The discussions also aim to empower the caregiver to make sure that these decisions are respected.
Post-intervention assessment (Visit 4):
The PI will start the meeting with a semi-structured interview (30-45 min) on the dyad's subjective experience with the intervention, positive and nega-tive effects, and challenges and suggestions to modify the intervention. Participants will also be asked to hand over copies of ACP documents produced during the intervention or after it in order to be analysed. After the interview, the PI will ask the patient and her/his relative to fill in psychometric scales: Hospital anxiety and depression scale (HADS), Decisional conflict scale, Personal autonomy scale and Zarit Burden Inventory.
- Conditions
- Alzheimer Disease
- Being tested
- Dementia-specific advance care planning
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia-specific advance care planningBehavioural
see detailed description
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | see detailed description Receives: Behavioral: Dementia-specific advance care planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participants' anxiety and depression levels
Changes in participants' anxiety and depression levels measured with the Hospital Anxiety and Depression scale before (V1) and after (V4) the intervention. The Hospital Anxiety and Depression Scale (HADS) allow the participant to assess her/his mood according to 24 items. Individual's anxiety and depression levels are calculated by summing the score obtained at the eponym subscales, 0 being no anxiety or depression and 21 high anxiety or depression.
Measured: Visit 1 and V4 (=V1 + 4-6 weeks)
Change in participants' decisional conflict level
Changes in participants' decisional conflict levels measured with the Decisional conflict scale before (V1) and after (V4) the intervention. The decisional conflict scale allow to participant to assess her/his ambivalence towards a specific treatment decision by choosing on a Lickert scale whether s/he strongly agrees (0 points), agrees (1 point), neither agrees nor disagrees (2 points), disagrees (3 points), or strongly disagrees (4 points) with a list of sentences. Scores are then summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: Visit 1 and V4 (=V1 + 4-6 weeks)
Change in proxies' perception of the burden
Changes in relative's perceptions of the burden measured with the Zarit Burden Inventory before (V1) and after (V4) the intervention. The Zarit Burden Inventory assesses relative's perceived burden of taking care of a sick and/or dependent loved one. Relatives have to answer to indicate if they experienced 22 different situations or feelings never (1 point), rarely (2 points), sometimes (3 points), quite frequently (4 points), or nearly always (5 points). Points at each item are summed: scores range from 22 (low perceived burden) to 110 (high perceived burden).
Measured: Visit 1 and V4 (=V1 + 4-6 weeks)
Changes in patients' psychological autonomy and perceived control
Changes in perceptions of patient's personal autonomy measured with the Psychological Autonomy Inventory before (V1) and after (V4) the intervention. The Psychological Autonomy Inventory allows the patient to indicate on a scale from 1 to 5 (1 being never and 5 all the time) how s/he feels autonomous in different aspects of life. Scores at the subscale of decisional control (items 3, 7, 10, 12, 14, 15, 16, 18, 19, 20, 25, 26, 27, and 28) are summed. Items at the subscale of behavioral control (items 1, 2, 4, 5, 6, 8, 9, 11, 13, 17, 21, 22, 23, and 24) are summed. A score of 14 means low decisional or behavioral control, a score of 70 means high decisional or behavioral control.
Measured: Visit 1 and V4 (=V1 + 4-6 weeks)
Participants' satisfaction with the intervention
Semi-structured interview at V4 explores dyad's experience with the intervention, whether advance decisions were documented during or after the intervention and how, and comments and suggestions to improve the intervention.
Measured: Visit 1 and V4 (=V1 + 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start3 Aug 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical trial has a sigle arm: all the dyads will go through the four visits.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Bosisio, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615027
- Sponsor's protocol ID
- 2018-00785
- Other IDs
- 2018
- Acronym
- ADIA
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the research group or for other studies
Publications
Sterie AC, Bosisio F, Rubli Truchard E, Jox RJ, Jones L. Negotiating participation in conversations about care planning between people living with mild neurocognitive disorders and their healthcare proxies: a single case analysis. Gerontologist. 2026 Apr 13;66(5):gnag011. doi: 10.1093/geront/gnag011.
PubMed 41692985Bosisio F, Sterie AC, Rubli Truchard E, Jox RJ. Implementing advance care planning in early dementia care: results and insights from a pilot interventional trial. BMC Geriatr. 2021 Oct 19;21(1):573. doi: 10.1186/s12877-021-02529-8.
PubMed 34666711
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia-specific Intervention of Advance Care Planning
- ClinicalTrials.gov ID
- NCT03615027
- Acronym / sponsor ID
- ADIA / 2018-00785
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 3 Aug 2018 (actual)
- 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.
This is a pilot study that aims to create a dementia-specific intervention of advance care planning (ACP) and test its feasibility and acceptance with min 20 max 30 patient-relative dyads.
The intervention is adapted from the Multiprofessional advance care planning and shared decision-making for end of life care (MAPS) Trials 1 and 2 made at the Zurich University Hospital.
The study design is longitudinal (historic): all the dyads will be asked to go through the process (4 visits, see 9.3 Procedures at each visit).
Detailed description
Study background and aims:
Advance care planning (ACP) is a structured communication process between an individual, his family, and his healthcare agent (if existing), facilitated by a healthcare provider. The aim is to identify the personal values of the individual, reflect on the meanings and consequences of anticipated illness scenarios, define goals and preferences of care for these situations, issue appropriate documents and legal instruments that will help direct future healthcare decisions, and review these steps at adequate intervals. ACP emphasizes communication in anticipation of a future deterioration of a person's health. Even though dementia entails the loss of decision-making capacity, advance care planning is yet to become widespread. This study aims to close the gap and create a dementia-specific ACP intervention that:
- Support patient autonomy through advance care planning
- Improve participants' satisfaction and perceived control;
- Increase planning decisions and surrogate's knowledge of patients' preferences and values.
Procedure and measure:
Pre-intervention assessment (Visit 1):
If the patient and her/his relative have both consented to the study, the PI will ask the patient and her/his relative to fil out psychometric scales: Hospital anxiety and depression scale (HADS), Decisional conflict scale, Personal autonomy scale and Zarit Burden Inventory. Then, the PI will realize a semi-structured interview on patient's val-ues and treatment preferences and caregiver's knowledge of patient's preferences and care planning decisions that have already been made. Participants will also be asked to hand out a copy of any pre-existing advance directives or other advance care planning document.
Intervention (Visit 2):
In the intervention this first conversation (45-90 min) with a specifically trained ACP facilitator aims to explain the goal and content of ACP and prompt the patient to reflect upon his/her values and preferences for healthcare and discuss them with his/her caregiver. In addition, the written decision aids will be explained and provided to the patient/caregiver to be read at home. At the end of the meeting, the facilitator will ask to set up the second meeting.
Intervention (Visit 3):
The second conversation of the ACP facilitator with the patient and her/his caregiver aims to help the patient to specify her/his preferences and trans-late them into actionable documentation. The discussions also aim to empower the caregiver to make sure that these decisions are respected.
Post-intervention assessment (Visit 4):
The PI will start the meeting with a semi-structured interview (30-45 min) on the dyad's subjective experience with the intervention, positive and nega-tive effects, and challenges and suggestions to modify the intervention. Participants will also be asked to hand over copies of ACP documents produced during the intervention or after it in order to be analysed. After the interview, the PI will ask the patient and her/his relative to fill in psychometric scales: Hospital anxiety and depression scale (HADS), Decisional conflict scale, Personal autonomy scale and Zarit Burden Inventory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical trial has a sigle arm: all the dyads will go through the four visits.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dementia-specific advance care planningsee detailed description |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patients older than 65 years
- Having been diagnosed with an early-stage dementia of Alzheimer's disease aetiology or mixed Alzheimer-vascular aetiology (Montreal cognitive assessement (MoCA) > 20 and Clinical dementia rating (CDR) < 1.5);
- Having been informed about the diagnosis by their treating physician and that are regularly followed by him/her;
- Patient that show interest in advance care planning or advance directives;
- Patients with psychiatric disorders can be included if their psychiatric symptoms are controlled and under the supervision of their psychiatrist at the Unit of psychogeriatric care;
Key exclusion criteria (10 listed)
- Patients that have a dementia associated with fronto-temporal lobe degeneration;
- Patients that have mild cognitive impairments (MCI);
- Patients that have moderate to severe cognitive disorders, anosognosia or else, assessed clinically or through scales or based on in-person screening, that suggest decision-making capacity may be impaired;
- The patient or her/his caregiver decide to withdraw from the study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
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 |
|---|---|---|
| Dementia-specific advance care planningsee detailed description | Behavioural | Intervention |
Primary outcome
Change in participants' anxiety and depression levels
Time frame: Visit 1 and V4 (=V1 + 4-6 weeks)
Changes in participants' anxiety and depression levels measured with the Hospital Anxiety and Depression scale before (V1) and after (V4) the intervention. The Hospital Anxiety and Depression Scale (HADS) allow the participant to assess her/his mood according to 24 items. Individual's anxiety and depression levels are calculated by summing the score obtained at the eponym subscales, 0 being no anxiety or depression and 21 high anxiety or depression.
Change in participants' decisional conflict level
Time frame: Visit 1 and V4 (=V1 + 4-6 weeks)
Changes in participants' decisional conflict levels measured with the Decisional conflict scale before (V1) and after (V4) the intervention. The decisional conflict scale allow to participant to assess her/his ambivalence towards a specific treatment decision by choosing on a Lickert scale whether s/he strongly agrees (0 points), agrees (1 point), neither agrees nor disagrees (2 points), disagrees (3 points), or strongly disagrees (4 points) with a list of sentences. Scores are then summed, divided by 16 and multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Change in proxies' perception of the burden
Time frame: Visit 1 and V4 (=V1 + 4-6 weeks)
Changes in relative's perceptions of the burden measured with the Zarit Burden Inventory before (V1) and after (V4) the intervention. The Zarit Burden Inventory assesses relative's perceived burden of taking care of a sick and/or dependent loved one. Relatives have to answer to indicate if they experienced 22 different situations or feelings never (1 point), rarely (2 points), sometimes (3 points), quite frequently (4 points), or nearly always (5 points). Points at each item are summed: scores range from 22 (low perceived burden) to 110 (high perceived burden).
Changes in patients' psychological autonomy and perceived control
Time frame: Visit 1 and V4 (=V1 + 4-6 weeks)
Changes in perceptions of patient's personal autonomy measured with the Psychological Autonomy Inventory before (V1) and after (V4) the intervention. The Psychological Autonomy Inventory allows the patient to indicate on a scale from 1 to 5 (1 being never and 5 all the time) how s/he feels autonomous in different aspects of life. Scores at the subscale of decisional control (items 3, 7, 10, 12, 14, 15, 16, 18, 19, 20, 25, 26, 27, and 28) are summed. Items at the subscale of behavioral control (items 1, 2, 4, 5, 6, 8, 9, 11, 13, 17, 21, 22, 23, and 24) are summed. A score of 14 means low decisional or behavioral control, a score of 70 means high decisional or behavioral control.
Participants' satisfaction with the intervention
Time frame: Visit 1 and V4 (=V1 + 4-6 weeks)
Semi-structured interview at V4 explores dyad's experience with the intervention, whether advance decisions were documented during or after the intervention and how, and comments and suggestions to improve the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Derived from this study: PubMed 41692985Sterie AC, Bosisio F, Rubli Truchard E, Jox RJ, Jones L. Negotiating participation in conversations about care planning between people living with mild neurocognitive disorders and their healthcare proxies: a single case analysis. Gerontologist. 2026 Apr 13;66(5):gnag011. doi: 10.1093/geront/gnag011.
- Derived from this study: PubMed 34666711Bosisio F, Sterie AC, Rubli Truchard E, Jox RJ. Implementing advance care planning in early dementia care: results and insights from a pilot interventional trial. BMC Geriatr. 2021 Oct 19;21(1):573. doi: 10.1186/s12877-021-02529-8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the research group or for other studies
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia-specific advance care planning in people with Alzheimer Disease, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Aug 2018. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Bosisio, PhD (213141053 ext. 0041, francesca.bosisio@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants' anxiety and depression levels (time frame: Visit 1 and V4 (=V1 + 4-6 weeks)). The study lists 5 primary outcomes in all. 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 NCT03615027, 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 7 Aug 2018.