EAL

MNT: RDN in Medical Team (2015)

Citation:

Cueto-Manzano AM, Martinex-Ramirez HR, Cortes-Sanabria L. Management of chronic kidney disease: Primary health-care setting, self-care and multidisciplinary approach. Clin Neph. 2010; 74(Suppl): S99-S104.

PubMed ID: 20979973

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To determine the effect of an educational program with a multi-disciplinary healthcare approach supported by self-help groups on the lifestyle and dietary habits of patients at high risk of developing chronic kidney disease (CKD).

Inclusion Criteria:

Patients in a family medicine unit in Mexico who had failed to meet clinical practice recommendations for the control of

Diabetes mellitus
Hypertension
Overweight or obesity.

Exclusion Criteria:

Not defined. Data was reported based on available adult patients that had previously not responded to treatments and the prospective observations of the study.

Description of Study Protocol:

Recruitment

Existing adult patients in the family medical practice who were not in control of diabetes mellitus, hypertension or overweight/obesity were invited to participate.

Design

Prospective cohort study with identified participants receiving defined multi-disciplinary and multi-pronged intervention over a six-month period.

Intervention

Participants received weekly two-hour educational intervention for four weeks with:
- Emotional management conducted by a social worker
- Nutritional patterns with a dietitian
- Exercise with a physical trainer
- Health-related problems with a family physician.
After the first four weeks, participants were seen every three months for assessment of goal achievements and every month with the physician for a regular visit. In addition, the subjects were divided into smaller groups of 20 people with a leader selected to coordinate, motivate and encourage the members of the group.

Statistical Analysis

Software was not specified but provided data includes mean, range and significance of P<0.05.

Data Collection Summary:

Timing of Measurements

Measurements were taken at baseline, three months and six months

Dependent Variables

Lifestyle questionnaire score including sectional components of knowledge and adherence, emotions, exercise, tobacco consumption, alcohol consumption and diet (total maximum healthy score 84)
Systolic blood pressure (mm Hg)
Diastolic blood pressure (mm Hg)
Body mass index (kg/m²)
Waist circumference (cm)
Glucose (mg per dL)
LDL-cholesterol (mg per dL)
Triglycerides (mg per dL)
Glomerular filtration rate (GFR) (ml per minute per 1.73m²)
Albuminuria (mg per 24 hours).

Independent Variables

Age
Gender
Illiteracy
Smoking
Alcohol intake.

Description of Actual Data Sample:

Initial N: N=184 patients
Attrition (final N): N=184 patients
Age: See table
Ethnicity: Mexico.

Other Relevant Demographics:

	Diabetes Mellitus	Hypertension	Overweight or Obesity
Patients, N	88	45	51
Age, years	54±10	54±12	43±13
Female, N (%)	66 (75)	28 (62)	44 (86)
Illiteracy, N (%)	9 (10)	1 (8)	1 (2)
Smoking, N (%)	7 (8)	2 (4)	4 (8)
Alcohol intake, N (%)	14 (16)	5 (11)	9 (18)

Anthropometrics

Age was significantly lower in the overweight and obesity group.

Location

Guadalajara, Jalisco, Mexico.

Summary of Results:

Key Findings

All groups reported a notable improvement in nutritional and exercise habits, as well as in management of their emotions and total score in the lifestyle questionnaire
Diabetics and hypertensives significantly improved the knowledge of their disease and adherence to treatment
Diabetics significantly reduced body mass index, waist circumference and blood glucose and increased GFR
Hypertensive patients significantly decreased systolic blood pressure, body mass index and waist circumference
Overweight and obese patients significantly decreased body mass index, waist circumference and blood glucose, and increased GFR
All observed changes were independent of pharmacological treatment, as medication regimens did not change over the course of the study.

Variable	DM Baseline	DM Final	HTN Baseline	HTN Final	Obese Baseline	Obese Final
Lifestyle questionnaire	51.8±10.1	65.4±9.0	54.7±10.2	67.0±8.0	52.8±8.9	66.1±8.2
Systolic BP (mm Hg)	129±19	124±12	145±3	130±18	117±11	120±11
Diastolic BP (mm Hg)	79±12	77±10	85±11	80±9	76±9	76±7
BMI (kg/m²)	34.0±6.4	33.1±6.3	35.6±5.2	33.9±5.7	35.4± 5.0	33.3±5.1
Waist circumference (cm)	103±12	102±13	109±11	104±12	106±13	100±10
Glucose (mg per dL)	170±65	148±52	114±30	110±23	100±13	98±12
LDL-cholesterol (mg per dL)	112 (92 to 137)	116 (96 to 140)	122 (94 to 146)	116 (92 to 157)	112 (97 to 139)	117 (86 to 142)
Triglycerides (mg per dL)	168 (129 to 223)	166 (127 to 229)	172 (126 to 259)	147 (128 to 203)	127 (95 to 189)	135 (115 to 127)
GFR (ml per minute per 1.73m²)	99 (81 to 123)	103 (86 to 128)	99 (84 to 127)	106 (81 to 147)	116 (94 to 147)	113 (87 to 150)
Albuminuria (mg per 24 hours)	6.3 (4.3 to 15.3)	6.5 (4.5 to 12.4)	5.6 (2.9 to 12.1)	4.4 (3.8 to 10.4)	5.8 (3.6 to 8.1)	7.0 (4.2 to 9.0)

Author Conclusion:

The implementation of educational strategies for patients involving multiple intervention, guided by health professionals (multi-disciplinary team including primary doctors, dietitians, nurses and social workers) and supported by self-help groups may be very helpful in improving lifestyle and dietary habits that negatively affect kidney function of patients at high risk of developing chronic kidney disease (CHD).

Funding Source:

University/Hospital:

Hospital de Especialidades, CMNO, IMSS, Guadalajara Mexico

Reviewer Comments:

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?		No
	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?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	Yes
4.	Was method of handling withdrawals described?		N/A
	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?	Yes
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.)	Yes
	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?	No
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	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?	No
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	Yes
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?	Yes
	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?	???
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	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