Caregiver Stress SyndromeENCODENCT05336344
Supporting Family Caregivers of Persons With Dementia
A study testing ENCODE in people with Caregiver Stress Syndrome and Anxiety, run by University of Pennsylvania at 1 site in United States.
Trial summary
Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress Syndrome, Anxiety, Depression
- What is being tested?
- ENCODE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 10 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- enrolled as a family/informal caregiver of a hospice patient with primary or secondary diagnosis of Alzheimer's disease or other related dementia
- responding with "yes" to the question about having any concerns about effectively managing their care recipient's pain
- 18 years or older
- no or only mild cognitive impairment
- speak and read English, with at least a 6th-grade education
Who cannot join
- Significant hearing loss that does not allow the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).
Read the detailed description
According to a report by the National Hospice and Palliative Care Organization published in 2020, over 180,000 Americans with a primary diagnosis of Alzheimer's disease or related dementias (ADRD) received hospice care in the United States in 2018. Although many of these patients and their families receive high quality care, numerous health care professionals have observed shortfalls in hospice care for patients with dementia, especially in the area of pain management. Past studies have shown a mixed impact of hospice enrollment on pain management for patients with ADRD. Shega et al found that roughly half of caregivers reported moderate or severe pain for patients with dementia, irrespective of hospice enrollment.
Core to the hospice philosophy is the goal to reduce or even eliminate suffering in patients and to support and address the needs of both patients and their families. Family caregivers, namely family and friends who provide informal, unpaid care to hospice patients, are essential to the delivery of hospice services; however, most lack formal healthcare training. A typical family caregiver of a hospice patient with ADRD will spend at least 46 hours per week assisting with activities of daily living, including personal hygiene, medication management, household chores, and transportation. Informal caregivers are 'on call' 24 hours a day and at high risk for chronic stress, deteriorating physical health, financial difficulties, and premature death. Informal caregivers suffer from high rates of depression and anxiety, and in the few studies that have focused on their experiences, pain management has been the most commonly expressed concern. Several studies have highlighted that challenges in communication about pain among patients, caregivers and clinicians is a major struggle for family caregivers; understanding the origin of this difficulty could lead to improvements in caregiver training and support. Many caregivers report feeling stressed about pain management and describe clinicians' strategies for pain management in ADRD care as "mysterious" or "suspicious".
In the general population of older adults with ADRD, attempts to precisely estimate the prevalence of pain and quality of pain management have met with varied success. One study of long-term dementia care units found that 18% to 30% of patients self reported pain, but prevalence of pain jumped to 50% when behavioral observation scales were used. Self-report of pain is limited in patients with advanced dementia, and the etiology of pain difficult to determine. In addition, patients may resist pain treatments due to their inability to understand the purpose of analgesia and may receive decreased benefit from analgesia due to the disruption of the placebo effect. Pharmaceutical pain treatments may also exacerbate symptoms of dementia such as agitation and confusion.
Based on preliminary work, whereby the investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, the team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators recently completed a single group pilot study of the ENCODE intervention that demonstrated feasibility, acceptability and preliminary efficacy on improving caregiver quality of life and reducing anxiety. This study proposes a 5-year randomized clinical trial in which caregivers of patients with ADRD will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group). The specific aims are:
Aim 1: To assess the impact of the ENCODE intervention on caregiver quality of life (primary outcome) and caregiver anxiety, depression, health and caregiver's perception of patient pain (secondary outcomes).
Hypothesis 1a: Caregivers in the intervention group will report higher levels of (covariate-adjusted) post intervention quality of life compared to caregivers in the attention control group.
Hypothesis 1b: Caregivers in the intervention group will report higher levels of (covariate-adjusted) post intervention health, and lower levels of (covariate-adjusted) anxiety and depression and patient pain compared to caregivers in the attention control group.
Aim 2: To assess caregivers' perceptions of and satisfaction with the ENCODE intervention.
Aim 3: To facilitate the translation of the intervention into practice, and more specifically:
Aim 3a: conduct an analysis comparing costs associated with the control and the intervention groups.
Aim 3b: identify barriers and facilitators to adoption of a behavioral intervention aiming to facilitate pain management in hospice
- Conditions
- Caregiver Stress Syndrome, Anxiety, Depression
- Being tested
- ENCODE
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENCODEBehavioural
a cognitive behavioral intervention for family caregivers to improve pain management skills and overall coping
| Study group | Role | What they receive |
|---|---|---|
| ENCODE Group | Experimental | The intervention consists of three weekly video-conferencing sessions scheduled at the caregiver's convenience. Each session is scheduled to last approximately 40 minutes. The ENCODE intervention is manualized and has related curriculum designed specifically for caregivers of patients with ADRD. The agenda for the first session (week 1) includes an assessment of caregivers' pain management challenges and concerns. Once the barriers or challenges are identified, the interventionist works specific problem solving therapy steps covered over the three sessions. Receives: Behavioral: ENCODE |
| Attention Control Group | No intervention | Caregivers in the attention control group will receive standard hospice services and complete the same measures and receive the same number of contacts as participants in the intervention group. Three video-conferencing calls will be scheduled based on the caregiver's availability following, if possible, a timeline between days 5 and 30 of the hospice admission. During these calls, the interventionist will allow caregivers in the attention control group to discuss their feelings, thoughts, and relationships. This "friendly call" intervention controls for the nonspecific aspects of treatment, i.e., the passage of time, amount of contact with a researcher, and the general support of an empathic, concerned and skilled professional and is based on the principles of nondirective supportive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Quality of Life-Index (CQLI-R) scores
The CQLI-R, a four-item measure of caregivers' quality of life (QOL), includes four dimensions: emotional, social, financial, and physical. Total score ranges from 0 to 40 (higher score indicates higher quality of life).
Measured: assessments at week 1, week 3 and 40 day follow-up
Secondary outcomes (3)
Change in Generalized Anxiety Disorder (GAD-7) for caregivers
The GAD-7 is a brief, valid tool for screening for GAD and assessing its severity in clinical practice and research. The total score is calculated by assigning scores of 0-3 for each of the seven items. Scores of 5, 10, and 15 are taken as the cut off points for mild, moderate, and severe anxiety, respectively. The GAD-7 score ranges from 0 to 21, higher score indicates higher level of anxiety.
Measured: assessments at week 1, week 3 and 40 day follow-up
Change in the Depression Scale of the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a nine-item tool for assessing and monitoring levels of depression. It assesses symptoms and functional impairment due to depression and derives a severity score. A higher score indicates higher level of depression. A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression
Measured: assessments at week 1, week 3 and 40 day follow-up
Change in the Pain Assessment in Advanced Dementia (PAINAD) Scale score
The PAINAD is a simple, valid, and reliable instrument for measurement of pain in noncommunicative patients with dementia. Unlike other scales developed for non-communicative patients that require extensive training and can only be administered by clinicians, PAINAD can be completed by caregivers themselves; it includes five items (breathing independent of vocalization, negative vocalization, facial expression, body language and consolability) generating a total score ranging from 0 to 10. A higher score indicates higher level of patient pain as assessed by the caregiver.
Measured: assessments at week 1, week2, week 3 and 40 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start15 Jul 2022
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Stress SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Demiris, PhD, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336344
- Sponsor's protocol ID
- 849217
- Acronym
- ENCODE
- Status last verified
- Aug 2026
- First submitted
- 5 Apr 2022
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate de-identified data may be shared with other researchers upon a Data Use Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Family Caregivers of Persons With Dementia
- ClinicalTrials.gov ID
- NCT05336344
- Acronym / sponsor ID
- ENCODE / 849217
- Conditions
- Caregiver Stress Syndrome, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 20 Apr 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.
Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).
Detailed description
According to a report by the National Hospice and Palliative Care Organization published in 2020, over 180,000 Americans with a primary diagnosis of Alzheimer's disease or related dementias (ADRD) received hospice care in the United States in 2018. Although many of these patients and their families receive high quality care, numerous health care professionals have observed shortfalls in hospice care for patients with dementia, especially in the area of pain management. Past studies have shown a mixed impact of hospice enrollment on pain management for patients with ADRD. Shega et al found that roughly half of caregivers reported moderate or severe pain for patients with dementia, irrespective of hospice enrollment.
Core to the hospice philosophy is the goal to reduce or even eliminate suffering in patients and to support and address the needs of both patients and their families. Family caregivers, namely family and friends who provide informal, unpaid care to hospice patients, are essential to the delivery of hospice services; however, most lack formal healthcare training. A typical family caregiver of a hospice patient with ADRD will spend at least 46 hours per week assisting with activities of daily living, including personal hygiene, medication management, household chores, and transportation. Informal caregivers are 'on call' 24 hours a day and at high risk for chronic stress, deteriorating physical health, financial difficulties, and premature death. Informal caregivers suffer from high rates of depression and anxiety, and in the few studies that have focused on their experiences, pain management has been the most commonly expressed concern. Several studies have highlighted that challenges in communication about pain among patients, caregivers and clinicians is a major struggle for family caregivers; understanding the origin of this difficulty could lead to improvements in caregiver training and support. Many caregivers report feeling stressed about pain management and describe clinicians' strategies for pain management in ADRD care as "mysterious" or "suspicious".
In the general population of older adults with ADRD, attempts to precisely estimate the prevalence of pain and quality of pain management have met with varied success. One study of long-term dementia care units found that 18% to 30% of patients self reported pain, but prevalence of pain jumped to 50% when behavioral observation scales were used. Self-report of pain is limited in patients with advanced dementia, and the etiology of pain difficult to determine. In addition, patients may resist pain treatments due to their inability to understand the purpose of analgesia and may receive decreased benefit from analgesia due to the disruption of the placebo effect. Pharmaceutical pain treatments may also exacerbate symptoms of dementia such as agitation and confusion.
Based on preliminary work, whereby the investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, the team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators recently completed a single group pilot study of the ENCODE intervention that demonstrated feasibility, acceptability and preliminary efficacy on improving caregiver quality of life and reducing anxiety. This study proposes a 5-year randomized clinical trial in which caregivers of patients with ADRD will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group). The specific aims are:
Aim 1: To assess the impact of the ENCODE intervention on caregiver quality of life (primary outcome) and caregiver anxiety, depression, health and caregiver's perception of patient pain (secondary outcomes).
Hypothesis 1a: Caregivers in the intervention group will report higher levels of (covariate-adjusted) post intervention quality of life compared to caregivers in the attention control group.
Hypothesis 1b: Caregivers in the intervention group will report higher levels of (covariate-adjusted) post intervention health, and lower levels of (covariate-adjusted) anxiety and depression and patient pain compared to caregivers in the attention control group.
Aim 2: To assess caregivers' perceptions of and satisfaction with the ENCODE intervention.
Aim 3: To facilitate the translation of the intervention into practice, and more specifically:
Aim 3a: conduct an analysis comparing costs associated with the control and the intervention groups.
Aim 3b: identify barriers and facilitators to adoption of a behavioral intervention aiming to facilitate pain management in hospice
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENCODE Group | Experimental | Behavioral: ENCODEThe intervention consists of three weekly video-conferencing sessions scheduled at the caregiver's convenience. Each session is scheduled to last approximately 40 minutes. The ENCODE intervention is manualized and has related curriculum designed specifically for caregivers of patients with ADRD. The agenda for the first session (week 1) includes an assessment of caregivers' pain management challenges and concerns. Once the barriers or challenges are identified, the interventionist works specific problem solving therapy steps covered over the three sessions. |
| Attention Control Group | No intervention | –Caregivers in the attention control group will receive standard hospice services and complete the same measures and receive the same number of contacts as participants in the intervention group. Three video-conferencing calls will be scheduled based on the caregiver's availability following, if possible, a timeline between days 5 and 30 of the hospice admission. During these calls, the interventionist will allow caregivers in the attention control group to discuss their feelings, thoughts, and relationships. This "friendly call" intervention controls for the nonspecific aspects of treatment, i.e., the passage of time, amount of contact with a researcher, and the general support of an empathic, concerned and skilled professional and is based on the principles of nondirective supportive therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- enrolled as a family/informal caregiver of a hospice patient with primary or secondary diagnosis of Alzheimer's disease or other related dementia
- responding with "yes" to the question about having any concerns about effectively managing their care recipient's pain
- 18 years or older
- no or only mild cognitive impairment
- speak and read English, with at least a 6th-grade education
Key exclusion criteria (1 listed)
- Significant hearing loss that does not allow the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)
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 |
|---|---|---|
| ENCODEa cognitive behavioral intervention for family caregivers to improve pain management skills and overall coping | Behavioural | ENCODE Group |
Primary outcome
Change in Caregiver Quality of Life-Index (CQLI-R) scores
Time frame: assessments at week 1, week 3 and 40 day follow-up
The CQLI-R, a four-item measure of caregivers' quality of life (QOL), includes four dimensions: emotional, social, financial, and physical. Total score ranges from 0 to 40 (higher score indicates higher quality of life).
3 secondary outcomes
Change in Generalized Anxiety Disorder (GAD-7) for caregivers
Time frame: assessments at week 1, week 3 and 40 day follow-up
Change in the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Time frame: assessments at week 1, week 3 and 40 day follow-up
Change in the Pain Assessment in Advanced Dementia (PAINAD) Scale score
Time frame: assessments at week 1, week2, week 3 and 40 day follow-up
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 24 Aug 2026.
- Individual participant dataSharing planned: No. Aggregate de-identified data may be shared with other researchers upon a Data Use Agreement.
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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 ENCODE in people with Caregiver Stress Syndrome and Anxiety, run by University of Pennsylvania 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 5 inclusion and 1 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 24 Aug 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 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 Caregiver Quality of Life-Index (CQLI-R) scores (time frame: assessments at week 1, week 3 and 40 day follow-up). 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 24 Aug 2026.