Dementia, Alzheimer Type, Weight Loss
Conditions
Keywords
caregiving, mealtimes, respite care, train-the-trainer
Brief 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. 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.
Interventions
BEHAVIORALPartners at Meals
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.
BEHAVIORALEnhanced Usual Condition
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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Participants did not know if they are in a site that is receiving the treatment or in the usual condition site. Randomization is by site, not by individuals.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monthly Weight in Pounds on a Scale for Person With Dementia | 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) | 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 | 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) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
Using a cluster randomized controlled experimental design based on each Respite Care Center's (RCCs; N=6) respective average monthly client census, RCCs were randomized to either the Partners at Mealtime (PAM) intervention (N=3; RCCs) or the control enhanced usual care (EUC) group (N=3; RCCs). Enrolled PWD/CG dyads were then allocated to the PAM intervention or the enhanced usual care (EUC) control groups based upon their RCC of attendance.
Participants by arm
| Arm | Count |
|---|---|
| Treatment - Partners at Meals (PAM) People with dementia (PWD) often lose weight and suffer subsequent health issues: the goal of this intervention is 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 are used initially and then monthly (x5) to record mealtimes in the home, and are reviewed by the volunteer with the family member at the monthly session to discuss areas where changes could be made.
Partners at Meals: The focus of the intervention is 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. | 54 |
| Enhanced Usual Condition (EUC) In the non-treatment respite care centers, an Enhanced Usual Condition will be delivered to caregivers of People with Dementia (PWD). This program consists 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) will lead these groups. Weight of the PWD is measured initially and monthly (x5); amount of food consumed will be measured using the Samsung tablets, also initially and monthly (x5).
Enhanced Usual Condition: Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive 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. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place. | 52 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 14 |
Baseline characteristics
| Characteristic | Treatment - Partners at Meals (PAM) | Enhanced Usual Condition (EUC) | Total |
|---|---|---|---|
| Age, Categorical Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregivers >=65 years | 20 Participants | 12 Participants | 32 Participants |
| Age, Categorical Caregivers Between 18 and 65 years | 7 Participants | 14 Participants | 21 Participants |
| Age, Categorical Persons with dementia <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Persons with dementia >=65 years | 26 Participants | 21 Participants | 47 Participants |
| Age, Categorical Persons with dementia Between 18 and 65 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Continuous Caregivers | 69.4 years STANDARD_DEVIATION 10.8 | 63.4 years STANDARD_DEVIATION 12.2 | 66.4 years STANDARD_DEVIATION 11.5 |
| Age, Continuous Persons with dementia | 81.0 years STANDARD_DEVIATION 7.7 | 73.9 years STANDARD_DEVIATION 10.7 | 77.9 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Caregivers Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Caregivers Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Persons with dementia Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Persons with dementia Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Persons with dementia Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Caregivers Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Caregivers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregivers White | 21 Participants | 24 Participants | 45 Participants |
| Race (NIH/OMB) Persons with dementia American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with dementia Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with dementia Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Persons with dementia More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with dementia Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with dementia Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Persons with dementia White | 22 Participants | 24 Participants | 46 Participants |
| Region of Enrollment United States | 54 participants | 52 participants | 106 participants |
| Sex: Female, Male Caregivers Female | 19 Participants | 22 Participants | 41 Participants |
| Sex: Female, Male Caregivers Male | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Persons with dementia Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Persons with dementia Male | 14 Participants | 16 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 27 | 0 / 21 |
| other Total, other adverse events | 3 / 27 | 1 / 21 |
| serious Total, serious adverse events | 6 / 27 | 5 / 21 |
Outcome results
Primary
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).
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL) | 81.6 score on a scale | Standard Deviation 11.1 |
| Enhanced Usual Condition (EUC) | Caregiver: Quality of Life Measured With European Quality of Life (Euro-QOL) | 70.8 score on a scale | Standard Deviation 19.9 |
Primary
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.
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Caregiver: Self Efficacy | 4.4 score on a scale | Standard Deviation 0.5 |
| Enhanced Usual Condition (EUC) | Caregiver: Self Efficacy | 4.0 score on a scale | Standard Deviation 0.7 |
Primary
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
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Monthly Weight in Pounds on a Scale for Person With Dementia | -2.1 pounds | Standard Deviation 8.1 |
| Enhanced Usual Condition (EUC) | Monthly Weight in Pounds on a Scale for Person With Dementia | -2.1 pounds | Standard Deviation 9.9 |
Primary
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.
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED) | 4.0 score on a scale | Standard Error 3.7 |
| Enhanced Usual Condition (EUC) | Person With Dementia: Dysfunctional Behavior at Meals Measured With the Edinburgh Feeding in Dementia Scale (EdFED) | 2.4 score on a scale | Standard Error 6.4 |
Primary
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.
Time frame: This was a 6-month study. We are reporting the change from baseline to the 6-month end of study time period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment - Partners at Meals (PAM) | Person With Dementia: Quality of Life | 33.7 score on a scale | Standard Error 7.5 |
| Enhanced Usual Condition (EUC) | Person With Dementia: Quality of Life | 33.6 score on a scale | Standard Error 6.4 |