# Abstract

 

## Background Patient education has proved beneficial in several but not all chronic disease. Inconsistent findings may rely on varying educational effects of various programs and differential effects on subgroups of patients. Patients' increase in disease knowledge may serve as a feedback to the educator on how well the education program works -- but may not be associated to relevant clinical outcomes like quality of life (QoL). This study aimed to investigate the effects of a group based education program for patients with gastroesophageal reflux disease (GERD) on disease knowledge and the association between knowledge and QoL. 

## Methods Patients with GERD were randomly allocated to education (102 patients) or control (109 patients). The education program was designed as a structured dialogue conveying information about pathophysiology, pharmacological and non-pharmacological treatment of GERD, patients' rights and use of healthcare. Outcomes were a 24 item knowledge test on GERD (score 0 -- 24) 2 and 12 months after the educational program and disease specific and general QoL (Digestive symptoms and disease impact, DSIQ, and General Health Questionnaire, GHQ). 

## Results Patients allocated to education achieved higher knowledge test scores than controls at 2 months (17.0 vs. 13.1, p < 0.001) and at 12 months (17.1 vs. 14.0, p < 0.001) follow-up. Knowledge test score was positively associated with having completed advanced school and inversely related to psychiatric illness and poor QoL as perceived by the patients at the time of inclusion. Overall, changes in knowledge test score were not associated with change in QoL. 

## Conclusion A group based education program for patients with GERD designed as a structured dialogue increased patients' disease knowledge, which was retained after 1 year. Changes in GERD-knowledge were not associated with change in QoL. 

## Trial registration ClinicalTrials.gov: NCT0061850 # Results 

## Patients Of 211 patients who were included, 102 were randomly allocated to GERD education and 109 to control. The GERD -education and control groups did not differ statistically with regards to socio-demographic variables; disease history or disease characteristics (Table [1](#) ). Of the patients who were allocated to GERD -education, 58 (56.9%) attended three lessons, 27 (26.5%) two and 5 (4.9%) one lesson. Twelve patients (11.8%) did not meet at all, of whom 5 were not able due to work or private obligations, 4 gave no reasons, 2 on grounds of other diseases and 1 did not wish to participate. At two months follow-up 90 patients (88%) in the GERD -education group and 100 patients (92%) in the control group responded completely. At 12 months 85 (83%) and 88 patients (81%) gave complete responses respectively. ::::table-wrap

::: caption
Socio-demographic and disease characteristics of patients allocated to
GERD-education vs. control groups, recorded at baseline.
:::

```
                                    **Education (n = 102)**   **Control (n = 109)**
```

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Age, years 47 (12) 47 (14)

Sex (female) 49% 50%

Primary school only 31% 34%

Cohabitating 77% 80%

Blue-collar worker 22% 22%

BMI (kg/m ^2^ ) 26 (3.6) 26 (4.7)

Previous history of serious disease 14% 17%

Length of GERD history (months) 166 (151) 169 (154)

Esophagitis 60% 51%

Having used H2-blocker or PPI 72% 63%

Ranitidine responder 41% (n = 74) 47% (n = 71)

Somatic comorbidity 53% 54%

Psychiatric comorbidity 8% 10%

Continuous variables are means (SD), categorical variables are
percentages.:::: 

## GERD-knowledge test Figure [1](#) shows mean GERD-knowledge at 2 and 12 months. The GERD -education group scored at both times higher than the control group (p < 0.001). The controls increased their knowledge test score significantly from 2 to 12 months follow-up (p < 0.001), whereas the GERD-educated patients did not. The difference in GERD-knowledge change between the patient education group and controls was 0.9 (p = 0.01). <figure> <p><img src="" /></p> <figcaption><strong>Knowledge test scores at 2 and 12 months follow-up for educated patients (edu) and patients allocated to control (contr).</strong>Plots show median (--), mean (- -), interquartile range (box) and 10th/90th (whiskers) percentiles. Diff. = difference in means.</figcaption> </figure> GERD-knowledge correlated at a significance level of p < 0.2 with 8 socio-demographic variables, disease history or disease characteristic variables and GHQ-lss at baseline in addition to random allocation. Multiple linear regression analysis rendered GERD -education, having completed advanced school, a lower GHQ-lss and absence of psychiatric illness at baseline as independently associated with higher knowledge test scores. The highest beta-value and explained variance (R ^2^ ) was found for allocation to GERD-education both at 2 and 12 months (Table [2](#) ). The length of GERD history showed no significant association to GERD-knowledge. ::::table-wrap
::: caption
Multiple linear regression analysis of knowledge test scores at 2 and 12
months follow-up as dependent variables and independent variables at
baseline which correlated with knowledge test score at p < 0.2
:::

```
                                         **2 months**   **12 months**                                                     
```

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*Independent variable* ^*1*^ ***Beta*** ***p*** ***R*^*2*^ *change*** ***Beta*** ***p*** ***R*^*2*^ *change***

Allocation to education group 3.6 *< 0.001* 0.29 2.7 *< 0.001* *0.17*
Formal educational level 1.1 *< 0.001* 0.06 1.2 *< 0.001* *0.07*
GHQ-score at time of inclusion - 0.1 *< 0.001* 0.08 - 0.2 *< 0.001* *0.12*
Psychiatric disease at time of inclusion - 1.6 *0.01* 0.02 - 1.5 *0.02* *0.02*
R ^2^ (adjusted) for the model 0.44 0.36

^1^ Variables excluded in both models: Previous history of serious
disease, esophagitis, having used PPI or H2-blocker, DSIQ sum-score,
global QoL.:::: Allocation to GERD-education, a higher number of days on sick leave at the time of inclusion, and previously serious disease at baseline correlated negatively to an increase in GERD-knowledge from 2 to 12 months (p < 0.20), while total duration of GERD correlated positively. Variables selected in the stepwise regression analysis and entered in the final adjusted regression models were number of days on sick leave at the time of inclusion and allocation to intervention. There was no statistically significant association between change in QoL variables and change in GERD-knowledge for the whole group of patients. An association was found between an increase in GERD-knowledge and deterioration in sense of coping (GHQ-30 profile: Coping failure) for patients who had completed advanced school (Table [3](#) ). For patients with primary school only, associations in the same direction were found in the DSIQ scales Gastric dysfunction, Life impairment and sum score, and an increase in GERD-knowledge test score. The explained variances in the final regression models (R ^2^ ) were 0.1 or less. We found no major differences in these results when analyses were performed separately for the GERD-education and the control group. ::::table-wrap
::: caption
Associations between change in GERD-knowledge from 2 to 12 months
follow-up and change in QoL-scores (DSIQ and GHQ-30 and their
subscales).
:::

```
                        **Digestive Symptoms and Impact Questionnaire -- DSIQ**   **General Health Questionnaire v. 30 -- GHQ-30**                                                                                                                                                                               
```

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```
                        ***Pain & bowel s.***                                     ***Gastric dysfunc.***                             ***Health impair.***   ***Life impair.***   ***Reflux***     ***Sum score***   ***Anxiety***    ***Well-being***   ***Depr.***     ***Coping***     ***Social dysfunc.***   ***Likert sum sc***
```

**All patients** 0.2 (0.18) 0.2 (0.18) 0.1 (0.59) 0.3 (0.10) 0.02 (0.84) 0.3 (0.13) 0.44 (0.25) 0.38 (0.46) 0.30 (0.50) 0.8 (0.06) 0.2 (0.60) 0.03 (0.15)

**Advanced school** 0.1 (0.65) 0.0 (1.0) 0.2 (0.51) 0.1 (0.66) 0.05 (0.76) 0.02 (0.57) 0.6 (0.16) - 0.8 (0.22) 0.8 (0.22) **1.0 (0.05)** 0.2 (0.49) 0.04 (0.08)

**Primary school only** 0.5 (0.09) **0.7 (0.01)** 0.07 (0.81) **0.8 (0.01)** - 0.01 (0.95) **0.8 (0.04)** - 0.04 (0.96) - 0.43 (0.63) - 0.2 (0.79) 0.2 (0.81) - 0.04 (0.95) 0.0 (0.92)

Numbers are β-values (p) in linear regression analyses adjusted for
selected baseline variables (see text) with change in GERD-knowledge as
dependent variable. Positive numbers indicate a reduced quality of life
with increasing GERD-knowledge. β-values (p < 0.05) are in bold.::::


Extracted trial result:
Outcome: GERD-knowledge (continuous)
Intervention: education
Comparator: control
Intervention group size: 102
Intervention mean: 17.1
Comparator group size: 109
Comparator mean: 14
Notes: no standard deviations given