Dementia, Alzheimer TypePAMNCT03622814
Partners at Meals - Respite Care and Home (PAM)
A study testing Partners at Meals and Enhanced Usual Condition in people with Dementia, Alzheimer Type and Weight Loss, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Type, Weight Loss
- What is being tested?
- Partners at Meals and Enhanced Usual Condition
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with Dementia (PWD): aged ≥ 60 years; attending a participating respite care center (RCC) at least once/week; living with or within the same property as caregiver (CG); diagnosis of Alzheimer's disease or related dementia with mild to moderate stage as demonstrated by the Functional Assessment Staging Scale (FAST) of 5 or greater and a MMSE of 12 or above; absence of wasting disorders (e.g., HIV/AIDS, heart or renal failure or COPD, end-stage cancer); some supervision required or dysfunctional behavior present (e.g., redirection)
- Caregiver (CG): lives with or on same property as the PWD; provides 4 hours or more of care/day; assists with ADLs including meals
- Volunteer: present at the RCC at least weekly (at least 4 hours/week); identify as comfortable in the teacher/coach role, and demonstrate ability to use televideo and photograph.
Who cannot join
- Persons with Dementia (PWD): not receiving enteral feeding or active treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by caregiver or on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included.
- Caregiver (CG): paid for services as caregiver; unable to speak or read English
- Volunteer: unable to read and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Mealtime Partnerships for People With Dementia in Respite Centers and at Home
The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.
Read the detailed description
The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.
The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.
- Conditions
- Dementia, Alzheimer Type, Weight Loss
- Being tested
- Partners at Meals, Enhanced Usual Condition
- Keywords
- caregiving, mealtimes, respite care, train-the-trainer
- Medical subject headings
- Alzheimer Disease, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partners at MealsBehavioural
Also called PAM
The focus of the intervention was to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. Families recorded three meals including behavior at home each month.
Enhanced Usual ConditionBehavioural
Also called EUC
Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites received training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Partners at Meals (PAM) | Experimental | People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention was to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets were used initially and then monthly (x5) to record mealtimes in the home, and were reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Weight of the PWD was measured initially and monthly (x5). Receives: Behavioral: Partners at Meals |
| Enhanced Usual Condition (EUC) | Placebo comparator | In the non-treatment respite care centers, an Enhanced Usual Condition was delivered to caregivers of People with Dementia (PWD). This program consisted of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) lead these groups. Weight of the PWD was measured initially and monthly (x5). Receives: Behavioral: Enhanced Usual Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Weight in Pounds on a Scale for Person With Dementia
Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months
Measured: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED)
The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure.
Measured: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Person With Dementia: Quality of Life
The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD:
Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life.
Measured: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL)
European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Caregiver: Self Efficacy
The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy.
Measured: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Aug 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, Alzheimer TypeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized cluster-design trial will be conducted in two large respite care centers (RCCs) with five sites that serve primarily white and African American persons with dementia. RCCs were randomized to the intervention condition (Partners at Meals; 3 sites) or \['enhanced usual care' (EUC)\] (2 sites). The primary unit of analysis is the person with dementia (PWD) and caregiver (CG).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Kelechi, Principal investigator, MUSC College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622814
- Sponsor's protocol ID
- Pro00064441
- Acronym
- PAM
- Status last verified
- Mar 2025
- First submitted
- 3 May 2018
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other investigators who have IRB approved studies; data will be anonymized.
Publications
Amella Krug EJ, Qanungo S, Martin KL, Mueller M, Madisetti M, Kelechi TJ. A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life. BMC Nutr. 2020 Jun 24;6:24. doi: 10.1186/s40795-020-00350-x. eCollection 2020.
PubMed 32587748
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mealtime Partnerships for People With Dementia in Respite Centers and at Home
- ClinicalTrials.gov ID
- NCT03622814
- Acronym / sponsor ID
- PAM / Pro00064441
- Conditions
- Dementia, Alzheimer Type, Weight Loss
- Keywords
- caregiving, mealtimes, respite care, train-the-trainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study was to test the efficacy of a mealtime intervention in respite care centers for people with dementia and their caregivers. Mealtimes become more challenging as dementia progresses causing nutritional and behavioral issues in the affected individuals. Using a train-the-trainer program built on the Partners at Meals model, volunteers in respite centers partner worked with caregivers and developed a mealtime plan that builds on the strengths of the person with dementia (PWD), and developed a supportive environment for change. A tele-health component was involved in the communication between the respite center volunteers/staff and families. Recruitment was limited to people attending the particular respite centers. Two large RCCs with a total of 5 sites of care in suburban and rural areas of SC were the sites of this project.
Detailed description
The goal of this study was to test the efficacy of a mealtime intervention (Partners at Meals) in respite care centers (RCCs) that provided a social model of care for people with dementia living in the community and support for their caregivers. Largely staffed by long-time volunteers, these centers support caregivers' ability to maintain their loved one in the home. Traditionally, support for social activities and mealtime offered by the RCCs cannot be extended to home. In this project, we used a telehealth interface to provide consultation to family caregivers in the context of home where problems arise.
The primary unit of analysis was PWD and their caregiver (CG) outcomes which included: a) PWD weight; b) dysfunctional behaviors at meals; c) quality of life (QOL) of both persons with dementia and their caregivers; and, d) CG self efficacy of managing meals at home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized cluster-design trial will be conducted in two large respite care centers (RCCs) with five sites that serve primarily white and African American persons with dementia. RCCs were randomized to the intervention condition (Partners at Meals; 3 sites) or ['enhanced usual care' (EUC)] (2 sites). The primary unit of analysis is the person with dementia (PWD) and caregiver (CG).
| Arm | Type | Receives |
|---|---|---|
| Treatment - Partners at Meals (PAM) | Experimental | Behavioral: Partners at MealsPeople with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention was to improve or maintain weight of a PWD, and to improve or maintain food intake. A train-the-trainer intervention is used with volunteers in Respite Care Centers who partner with family caregivers of PWD. Designed to be personalized to the PWD and focusing on his/her existing strengths and compensating for his/her deficits in mealtime management, sessions occur initially (1 hr) and every month (~30 mins) to reinforce key areas of behavioral or environmental change. Samsung tablets were used initially and then monthly (x5) to record mealtimes in the home, and were reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made. Weight of the PWD was measured initially and monthly (x5). |
| Enhanced Usual Condition (EUC) | Placebo comparator | Behavioral: Enhanced Usual ConditionIn the non-treatment respite care centers, an Enhanced Usual Condition was delivered to caregivers of People with Dementia (PWD). This program consisted of enhanced training in caregiving using components from a module of the evidence-based Savvy Caregiver program (K. Hepburn) given in a group setting with opportunity for a question and answer period; the program is given for new enrollees and every 6 months. The PI (TK), the nutritionist (KM) or the Program Manager (MCP) lead these groups. Weight of the PWD was measured initially and monthly (x5). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons with Dementia (PWD): aged ≥ 60 years; attending a participating respite care center (RCC) at least once/week; living with or within the same property as caregiver (CG); diagnosis of Alzheimer's disease or related dementia with mild to moderate stage as demonstrated by the Functional Assessment Staging Scale (FAST) of 5 or greater and a MMSE of 12 or above; absence of wasting disorders (e.g., HIV/AIDS, heart or renal failure or COPD, end-stage cancer); some supervision required or dysfunctional behavior present (e.g., redirection)
- Caregiver (CG): lives with or on same property as the PWD; provides 4 hours or more of care/day; assists with ADLs including meals
- Volunteer: present at the RCC at least weekly (at least 4 hours/week); identify as comfortable in the teacher/coach role, and demonstrate ability to use televideo and photograph.
Key exclusion criteria (3 listed)
- Persons with Dementia (PWD): not receiving enteral feeding or active treatment by a speech pathologist/therapist; not diagnosed with dysphagia as identified by caregiver or on RCC Intake Sheet. Those enrolled in or qualifying for hospice will not be included.
- Caregiver (CG): paid for services as caregiver; unable to speak or read English
- Volunteer: unable to read and speak English
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 |
|---|---|---|
| Partners at MealsAlso: PAMThe focus of the intervention was to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals. Families recorded three meals including behavior at home each month. | Behavioural | Treatment - Partners at Meals (PAM) |
| Enhanced Usual ConditionAlso: EUCEnhanced Usual Condition (EUC) Staff and volunteers at the EUC sites received training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. | Behavioural | Enhanced Usual Condition (EUC) |
Primary outcome
Monthly Weight in Pounds on a Scale for Person With Dementia
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
Assessed by unit of measure in pounds; reported as mean difference in pounds from baseline to follow-up at 6 months
Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED)
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
The Edinburgh Feeding in Dementia Scale (EdFED) is an observational instrument used across settings to evaluate feeding problem behavior. Using Guttmann Scaling, the EdFED Q has 4 items that measure level of assistance and 6 behavioral descriptors of specific mealtime behaviors; all are each rated 'never, sometimes, often' and cannot be rated 0, 1, 2, respectively, producing a range of 0-20 with higher scores indicating more problem behaviors. The instrument was used to also assess specific behaviors seen in moderate stage dementia such as wandering, distracted, perseverating, unable to use utensils, premature oral closure.
Person With Dementia: Quality of Life
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
The QOL scale in Alzheimer's disease (QOL--AD) is a 13--item rating of domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole. Scoring instructions for QOL-AD: Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4. The total score is the sum of all 13 items (scoring ranging from 13 to 52. Higher scores indicated better quality of life.
Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL)
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
European Quality of Life (Euro--QL) measures 5 domains: mobility, self--care, usualactivities, pain/discomfort, and depression and have three levels of functioning each (no problems, some problems, and unable to/extreme problems). The VAS is a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Caregiver: Self Efficacy
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
The self-efficacy score was a 8--item likert scale with each item rated from 1--5 (unable to most able). A total score for the instrument is provided by summing the scores of each item and dividing by the number of items producing a score in the range of 1-5. Higher overall mean scores indicate greater self efficacy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32587748Amella Krug EJ, Qanungo S, Martin KL, Mueller M, Madisetti M, Kelechi TJ. A cluster randomized controlled trial to assess the efficacy of a telehealth-based train-the-trainer mealtime intervention delivered by respite care center volunteers to caregivers of persons with dementia to improve nutritional outcomes and quality of life. BMC Nutr. 2020 Jun 24;6:24. doi: 10.1186/s40795-020-00350-x. eCollection 2020.
- Individual participant dataSharing planned: Yes. IPD will be shared with other investigators who have IRB approved studies; data will be anonymized.
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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.
Teresa Kelechi principal investigator
MUSC College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partners at Meals and Enhanced Usual Condition in people with Dementia, Alzheimer Type and Weight Loss, run by Medical University of South Carolina 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 3 inclusion and 3 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 10 Apr 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Monthly Weight in Pounds on a Scale for Person With Dementia (time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.). 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 NCT03622814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.