Dementia of Alzheimer TypeIBCNCT05524181
Telehealth-enabled Integrated Palliative Care for People With Dementia
A study testing Telehealth Integrated Primary Care (TIPC) in people with Dementia of Alzheimer Type and Alzheimer Disease, run by Thomas Jefferson University at 1 site in United States.
Trial summary
In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia of Alzheimer Type, Alzheimer Disease, Frontotemporal Degeneration
- What is being tested?
- Telehealth Integrated Primary Care (TIPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 14 Nov 2024
- 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
- Over 18
- Individuals diagnosed with Alzheimer's Disease, Alzheimer's Disease Related Dementias, (including frontotemporal degeneration, Lewy body dementia, vascular contributions to cognitive impairment and dementia, or mixed etiology dementias), or patients billed for cognitive impairment in the last three years that have a Jefferson PCP
- Individuals with access to a smart phone, computer, or some other telehealth-capable technology
- English-speaking individuals
Who cannot join
- Traumatic Brain Injuries
- Incarceration
- Homelessness
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. This research team will test the TIPC intervention to assess support for patients among a population of persons with dementia (PwD). Participants will be enrolled in the study for a 12 month period.
This study's aims are 1) to explore the impact of the TIPC intervention on patient-important outcomes, engagement with community-based support provided through insurers, advanced care planning (primarily identification of health-care proxy), and patterns of hospice and healthcare utilization in the target population and 2) to evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of a TIPC model, and apply findings from this work to the development of a larger randomized control trial designed to assess long-term efficacy of TIPC intervention.
Read the detailed description
One in 3 deaths for those over the age of 65 are caused by Alzheimer's or related dementia. Lack of goals-of-care conversations with these patients drives up end-of-life healthcare costs due to excessive use of medical procedures and places unnecessary decision-making burden on caregivers. Such realities exhibit how existing models of specialty palliative care are suffering too great of a workforce shortage to adequately meet the needs of increasing numbers of PwD and are also inaccessible to underrepresented minorities (URMs) due to cost. Implementing a TIPC model could improve these outcomes through intersectional engagement of relevant health entities to carve more concrete care goals and drive down overall care cost.
This trial will enroll 50 patients and caregivers (when appropriate). Half of the patient participants will be given the TIPC intervention and all participants will be assessed over 12 months to assess changes in patient-important outcomes. For both groups, the researchers will evaluate goal attainment, quality of life, decision making, caregiver support/burden, and clinician/payor satisfaction. Assessments will be ongoing throughout the year (baseline, 3, 6, 9, and 12 months) to fully illustrate what kind of sustained impact or change in trajectory this brief intervention may have, and if other gaps are later identified.
Patient participants will be recruited from Jefferson EMR reports, physician referrals, and other forms of outreach. Patient participants will be randomly assigned to study groups (25 intervention, 25 control). If a patient is randomized to the intervention group, researchers will ask if they have a caregiver so that they may be enrolled in the study as well. Intervention subjects will partake in two telehealth visits as a part of the TIPC model. The first telehealth visit will focus on ACP and identifying patient-important outcomes via a web-based tool for discussion with a palliative care (PC) specialist. The second telehealth visit will involve patient communication of their patient important outcomes (PIOs) to a primary care provider (PCP) and the translation of those PIOs into care plans for ongoing management. Control subjects will be followed as they continue with their usual standard of care. They will also complete all measures at pre-specified time points and researchers will assess for changes in GAS, provider burden and decision making as well as hospitalizations, hospice, palliative care plans.
All patient/caregiver dyads assigned to the intervention group will be interviewed remotely after the intervention via survey to assess their goal attainment, satisfaction with care and connectivity to community resources.
Evaluation of patient outcomes of the TIPC model will be ongoing and through an assets/strengths-based framework. At baseline, 3, 6, 9, and 12 months, patient quality of life, decision-making, and caregiver support/burden will be measured through a series of follow-up assessments.
At 3, 6, 9, and 12 months, the degree to which intervention subjects felt each of their PIOs was met will be self-reported by the patient/caregiver.
To substantiate intervention impact on patients, both clinical and implementation outcomes (payor engagement, changes in level of care, recurrent hospitalizations, transition to hospice, intervention uptake, PCP satisfaction) will be measured and evaluated 6+ months post-intervention via retrospective data review. This is with the exception of PCP satisfaction which is to be self-reported following the same acceptability measures as the intervention subjects.
- Conditions
- Dementia of Alzheimer Type, Alzheimer Disease, Frontotemporal Degeneration, Lewy Body Dementia, Vascular Cognitive Impairment, Vascular Dementia
- Being tested
- Telehealth Integrated Primary Care (TIPC)
- Medical subject headings
- Alzheimer Disease, Lewy Body Disease, Dementia, Vascular, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Integrated Primary Care (TIPC)Other
Also called TIPC
The TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, 6, 9, and 12 months. Receives: Other: Telehealth Integrated Primary Care (TIPC) |
| Control | No intervention | Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, 6, 9 and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Goal Attainment
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Measured: 3 months
Change in Goal Attainment
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Measured: 6 months
Change in Goal Attainment
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Measured: 9 months
Change in Goal Attainment
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Measured: 12 months
Change in Disease-Related Quality of Life
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Measured: Baseline
Change in Disease-Related Quality of Life
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Measured: 3 months
Change in Disease-Related Quality of Life
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Measured: 6 months
Change in Disease-Related Quality of Life
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Measured: 9 months
Change in Disease-Related Quality of Life
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Participants can score up to 52 points with a higher score being positively associated with a higher quality of life.
Measured: 12 months
Change in Decision-Making
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Measured: Baseline
Change in Decision-Making
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Measured: 3 months
Change in Decision-Making
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Measured: 6 months
Change in Decision-Making
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Measured: 9 months
Change in Decision-Making
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Measured: 12 months
Change in Caregiver Support/Burden
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Measured: Baseline
Change in Caregiver Support/Burden
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Measured: 3 months
Change in Caregiver Support/Burden
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Measured: 6 months
Change in Caregiver Support/Burden
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Measured: 9 months
Change in Caregiver Support/Burden
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Measured: 12 months
Secondary outcomes (1)
Feasibility, Acceptability, and Satisfaction regarding TIPC Intervention
Participants in the intervention group will report their experience with the TIPC model via survey questions. Participants will indicate whether or not they strongly disagree, disagree, have no opinion, agree, or strongly agree with a series of statements asking them about their experience with TIPC intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start29 Jun 2022
- Primary completion1 Aug 2024
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of Alzheimer TypeStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Model description
- Participants will be randomized to intervention or control group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Independence Blue Cross
- Responsible party
- Principal investigator, Brooke Worster, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524181
- Sponsor's protocol ID
- 080-27000-U33701
- Other IDs
- #22G.239
- Acronym
- IBC
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth-enabled Integrated Palliative Care for People With Dementia
- ClinicalTrials.gov ID
- NCT05524181
- Acronym / sponsor ID
- IBC / 080-27000-U33701
- Conditions
- Dementia of Alzheimer Type, Alzheimer Disease, Frontotemporal Degeneration, Lewy Body Dementia, Vascular Cognitive Impairment, Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Independence Blue Cross
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 1 Sep 2022 (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.
In prior work, this team developed a telehealth primary care model (TIPC), designed in close partnership with patients and clinicians to address a widespread increase in telehealth use during the COVID-19 pandemic. This research team will test the TIPC intervention to assess support for patients among a population of persons with dementia (PwD). Participants will be enrolled in the study for a 12 month period.
This study's aims are 1) to explore the impact of the TIPC intervention on patient-important outcomes, engagement with community-based support provided through insurers, advanced care planning (primarily identification of health-care proxy), and patterns of hospice and healthcare utilization in the target population and 2) to evaluate patient, caregiver, and clinical team perspectives of feasibility and acceptability of a TIPC model, and apply findings from this work to the development of a larger randomized control trial designed to assess long-term efficacy of TIPC intervention.
Detailed description
One in 3 deaths for those over the age of 65 are caused by Alzheimer's or related dementia. Lack of goals-of-care conversations with these patients drives up end-of-life healthcare costs due to excessive use of medical procedures and places unnecessary decision-making burden on caregivers. Such realities exhibit how existing models of specialty palliative care are suffering too great of a workforce shortage to adequately meet the needs of increasing numbers of PwD and are also inaccessible to underrepresented minorities (URMs) due to cost. Implementing a TIPC model could improve these outcomes through intersectional engagement of relevant health entities to carve more concrete care goals and drive down overall care cost.
This trial will enroll 50 patients and caregivers (when appropriate). Half of the patient participants will be given the TIPC intervention and all participants will be assessed over 12 months to assess changes in patient-important outcomes. For both groups, the researchers will evaluate goal attainment, quality of life, decision making, caregiver support/burden, and clinician/payor satisfaction. Assessments will be ongoing throughout the year (baseline, 3, 6, 9, and 12 months) to fully illustrate what kind of sustained impact or change in trajectory this brief intervention may have, and if other gaps are later identified.
Patient participants will be recruited from Jefferson EMR reports, physician referrals, and other forms of outreach. Patient participants will be randomly assigned to study groups (25 intervention, 25 control). If a patient is randomized to the intervention group, researchers will ask if they have a caregiver so that they may be enrolled in the study as well. Intervention subjects will partake in two telehealth visits as a part of the TIPC model. The first telehealth visit will focus on ACP and identifying patient-important outcomes via a web-based tool for discussion with a palliative care (PC) specialist. The second telehealth visit will involve patient communication of their patient important outcomes (PIOs) to a primary care provider (PCP) and the translation of those PIOs into care plans for ongoing management. Control subjects will be followed as they continue with their usual standard of care. They will also complete all measures at pre-specified time points and researchers will assess for changes in GAS, provider burden and decision making as well as hospitalizations, hospice, palliative care plans.
All patient/caregiver dyads assigned to the intervention group will be interviewed remotely after the intervention via survey to assess their goal attainment, satisfaction with care and connectivity to community resources.
Evaluation of patient outcomes of the TIPC model will be ongoing and through an assets/strengths-based framework. At baseline, 3, 6, 9, and 12 months, patient quality of life, decision-making, and caregiver support/burden will be measured through a series of follow-up assessments.
At 3, 6, 9, and 12 months, the degree to which intervention subjects felt each of their PIOs was met will be self-reported by the patient/caregiver.
To substantiate intervention impact on patients, both clinical and implementation outcomes (payor engagement, changes in level of care, recurrent hospitalizations, transition to hospice, intervention uptake, PCP satisfaction) will be measured and evaluated 6+ months post-intervention via retrospective data review. This is with the exception of PCP satisfaction which is to be self-reported following the same acceptability measures as the intervention subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to intervention or control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telehealth Integrated Primary Care (TIPC)Individuals in the intervention group will undergo a series of two telehealth video visits and a series of survey assessments at baseline, 3, 6, 9, and 12 months. |
| Control | No intervention | –Individuals in the control group will continue with their usual standard of care and undergo a series of survey assessments at baseline, 3, 6, 9 and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18
- Individuals diagnosed with Alzheimer's Disease, Alzheimer's Disease Related Dementias, (including frontotemporal degeneration, Lewy body dementia, vascular contributions to cognitive impairment and dementia, or mixed etiology dementias), or patients billed for cognitive impairment in the last three years that have a Jefferson PCP
- Individuals with access to a smart phone, computer, or some other telehealth-capable technology
- English-speaking individuals
Key exclusion criteria (4 listed)
- Traumatic Brain Injuries
- Incarceration
- Homelessness
- Pregnancy
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 |
|---|---|---|
| Telehealth Integrated Primary Care (TIPC)Also: TIPCThe TIPC model of intervention incorporates video visits across research clinicians and patients' existing care clinicians for more synergized and accessible care provision for a given clinical indication. The first TIPC visit will center around the patient setting care goals for themselves and their caregiver with the help of a palliative care physician. The second TIPC visit will focus on assessing goal attainment and also close the care loop between their existing care team, a research-appointed palliative care team, and their involvement in the study. | Other | Intervention |
Primary outcome
Change in Goal Attainment
Time frame: 3 months
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Change in Goal Attainment
Time frame: 6 months
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Change in Goal Attainment
Time frame: 9 months
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Change in Goal Attainment
Time frame: 12 months
Participants identify their own primary goals related to their care using the Goal Attainment Scaling (GAS) system, and report the degree to which each goal was met. Patients will set 2 concrete care goals and report if they feel like they met these goals much less than expected, less than expected, as expected, more than expected, or much more than expected.
Change in Disease-Related Quality of Life
Time frame: Baseline
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Change in Disease-Related Quality of Life
Time frame: 3 months
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Change in Disease-Related Quality of Life
Time frame: 6 months
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Change in Disease-Related Quality of Life
Time frame: 9 months
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Patients can score up to 52 points with a higher score being associated with a higher quality of life.
Change in Disease-Related Quality of Life
Time frame: 12 months
Participants report their overall quality of life by utilizing the Quality of Life in Alzheimer's Disease Scale (QoL-AD). These metrics include but are not limited to: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole. A summary index score is derived by applying an appropriate value set to the responses for each question (poor=1, fair=2, good=3, excellent=4). Participants can score up to 52 points with a higher score being positively associated with a higher quality of life.
Change in Decision-Making
Time frame: Baseline
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Change in Decision-Making
Time frame: 3 months
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Change in Decision-Making
Time frame: 6 months
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Change in Decision-Making
Time frame: 9 months
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Change in Decision-Making
Time frame: 12 months
Participants assess the extent to which they are involved in everyday decision making (e.g., when to get up, what foods to buy) the Decision-Making Involvement Scale (DMI). A summary index score is derived by applying an appropriate value set to the responses for each question (not at all involved=0, a little involved=1, fairly involved=2, very involved=3). Participants can score up to 45 points with a higher score being positively associated with a higher level of decision involvement.
Change in Caregiver Support/Burden
Time frame: Baseline
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Change in Caregiver Support/Burden
Time frame: 3 months
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Change in Caregiver Support/Burden
Time frame: 6 months
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Change in Caregiver Support/Burden
Time frame: 9 months
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
Change in Caregiver Support/Burden
Time frame: 12 months
Caregivers of participants explore the personal and role strain that they experience via the Zarit Burden Inventory (ZBI22). A summary index score is derived by applying an appropriate value set to the responses for each question (never=1, rarely=2, sometimes=3, quite frequently=4, nearly always=5). Participants can score up to 88 points with a higher score being negatively associated with a higher level of burden experienced by the caregiver.
1 secondary outcome
Feasibility, Acceptability, and Satisfaction regarding TIPC Intervention
Time frame: 3 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 12 Feb 2025.
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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.
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 Telehealth Integrated Primary Care (TIPC) in people with Dementia of Alzheimer Type and Alzheimer Disease, run by Thomas Jefferson University at 1 site in United States.
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 12 Feb 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 United States. 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?
Change in Goal Attainment (time frame: 3 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.