EAL

UWL: Food, Appetite and Environment (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To follow weight changes in patients with moderate and severe dementia and analyze how these changes related to biological and psychological parameters after staff education and support in integrity promoting care
To describe meal environment and routines relative to the intervention.

Inclusion Criteria:

Resident at one of the two nursing home sites selected for inclusion
Severe disability in ADL functioning based upon Katz-ADL index and the GBS motor function subscale.

Exclusion Criteria:

Patient declined inclusion in the research protocol
Relatives of the patient declined inclusion in the research protocol.

Description of Study Protocol:

Recruitment

Nursing homes within a given geographical area were asked to participate
Of the nursing homes that were accepted, two were assessed as being the most equal concerning the patients' cognitive and physical function and were accepted for inclusion in the study
One of the homes served as the intervention site, another served as the control site.

Design

Integrity promoting care, based on the Erikson theory of eight stages of man and its application to dementia care, was taught to all staff of the intervention ward during a one-week course and three months of supported investigation.

Intervention

A one-week course to the entire staff of the interventional unit was given by a psychologist and an instructor of nursing science, based on Erikson's theory on the eight stages of man
The training consisted of 20 hours of lectures and 18 hours of group discussions
Training focused on human relationships, normal aging, integrity, confusion and dementia disorders
Three main messages were given to providers:
- Care should be provided in such a way that the patient's experience of integrity was promoted
- A model of interaction with demented patients was also taught
- The environment should be made calmer, homelike and easier for the patients to interpret.

Statistical Analysis

Student's paired T-test on the individual weight differences between the first (M1) and the second measurements (M2)
Spearman's correlation coefficient was used for correlation analyses of the individual weight changes related to the biological and psychological parameters.

Data Collection Summary:

Timing of Measurements

Start of the study (M1)
After the intervention (M2).

Dependent Variables

Weights.

Independent Variables

A one-week course to the entire staff of the interventional unit was given by a psychologist and an instructor of nursing science, based on Erikson's theory on the eight stages of man
The training consisted of 20 hours of lectures and 18 hours of group discussions
Training focused on human relationships, normal aging, integrity, confusion and dementia disorders
Three main messages were given to providers:
- Care should be provided in such a way that the patient's experience of integrity was promoted
- A model of interaction with demented patients was also taught
- The environment should be made calmer, homelike and easier for the patients to interpret.

Control Variables

Patient cognitive function
Patient physical function.

Description of Actual Data Sample:

Initial N

28 intervention patients were housed, 18 were included
30 control ward patients were housed, 15 were included.

Attrition (Final N)

18 intervention patients
15 control ward patients
Some patients did not want to participate and their relatives were against it, some died.

Age

Intervention unit average age was 82.4±7.6 years
Control unit average age was 82.0±4.5 years.

Other Relevant Demographics

19 patients with Alzheimer's
One patient with multiple sclerosis with dementia
One patient with Parkinson's disease with dementia
Six patients with multi-infract dementia

Anthropometrics

The intervention ward and the control ward were similar on the motor and intellectual subscale.

Location:

Two nursing homes in the middle of Sweden.

Summary of Results:

Variables

Treatment Group

Mean and SD

Control group

Mean and SD

Statistical Significance of Group Difference

Weight changes (kg)

+0.53 (3.70)

-4.10 (5.03)

P=0.01

Other Findings

There was a relationship between improved weight and improved intellectual function during the study period
There was no significant correlation between the individual weight changes in the subscales of motor performance, increased appetite or changes in biochemical parameters
Positive changes in the atmosphere were found after the intervention and the most prominent differences observed were the increases in weight for 13 of the 18 intervention ward patients compared with two of 15 in the control ward
No weight changes were related to the type of dementia
According to the staff, increased contact with the patients and a more pleasant atmosphere resulted when the meal environment and routines were changed.

Author Conclusion:

Weight increases in 13 of 18 patients compared with two of 15 patients in the control ward
No weight changes were related to type of dementia
The individual weight changes correlated significantly to changes in the intellectual functions
Relationships between weight change, increased motor function and increased appetite were non-significant
There was no significant relationship between weight changes and changes in biochemical parameters
According to staff, increased contact with patients and a more pleasant atmosphere resulted when the meal atmosphere and routines were changed.

Funding Source:

Government:

Orebro County Council

Reviewer Comments:

Small sample size
Absence of power calculations
Food intake was not weighed or recorded
Positive results are suggested to be reliable as they are in line with the results from other results in the main project
Food served to both wards came from the same central kitchen; the differences in weight are, therefore, interpreted due to factors within the ward.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	No
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		???
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	No
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	???
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	Yes
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	Yes
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		???
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments described?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	???
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes