Effectiveness of Health Literacy in Patients With Type 2 Diabetes Mellitus on a Primary Health Care Protocol: a Randomized Pragmatic Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Health literacy through the use of Health Literacy Questionnaire - HLQ.
Study Overview
Brief Summary
The primary objective of this pragmatic trial was to analyze the effectiveness of health literacy in patients with type 2 Diabetes mellitus (DM2) on a protocol of care in Primary Health Care (PHC) units. The secondary objective was to analyze the effectiveness of knowledge about diabetes, self-efficacy, and glycated hemoglobin (HbA1c) in DM2 patients on a PHC protocol, as compared to the regular care provided by the municipality. Patients from four Family Health Units (FHU) were part of the study, two units as control group (CG) - Usual Assessment, two as intervention group (IG) - Multidisciplinary Assessment, with 44 subjects in each group. The IG mirrors the care protocol, which includes individual visits with physician, nurse, and nutritionist, in addition to systematized collective activities. The CG received the usual care. The research raises the hypothesis that subjects in the IG had a better understanding of aspects related to the disease and were more active in their own health care, as compared to patients who did not receive the intervention.
Detailed Description
This research was structured together with professionals who work in the management of the Municipal Health Department of the municipality under study due to the intention of implementing multidisciplinary care for people with Diabetes Mellitus, considering health literacy (HL) and national guidelines as the basis for structuring the assessment protocol. The research is also part of the Municipal Government Program, enhancing the knowledge translation and social impact. Therefore, it was decided to carry out a pragmatic trial, characterized by evaluating the effectiveness of interventions in a real scenario (Zuidgeest et al., 2017). The development of pragmatic trials contribute to the identification of scientific evidence that reduces gaps in primary health care, improving the Brazilian public health system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of Type 2 Diabetes mellitus Disease
- •Must be able to read and speak Portuguese
- •Being followed exclusively at the primary health care unit for the disease at the beginning of the study
- •Not participating in other studies involving diabetes mellitus
Exclusion Criteria
- •Pregnancy
- •Physical health problems that prevent the patient from coming to the unit
- •Hearing impairment that compromises communication
- •Cognitive problems according to the MMSE cutoff points
- •History of serious psychiatric disorder recorded in the medical record
- •Patients not located after three attempts of home visits on different days and times
Arms & Interventions
Usual Assessment
The participants in the usual assessment were provided regular care, including at least one medical appointment every six months with prescription review.
Multidisciplinary Assessment
The participants in the multidisciplinary assessment were followed by teams from the study target-units, by individual and collective interviews, which mirror the care protocol. The frequency of individual visits was at least every six months by a nurse, a physician, and a nutritionist. Regarding the collective activities, the educational groups met for approximately 1 hour and 30 minutes on monthly basis over a period of six months. Considering that there were two FHU in the IG, each team held one activity per month. For the development of the collective activities, methods recognized for intensifying integration and participation, such as using simple language and confirming the participants' understanding of the information covered in the group were recommended.
Intervention: Multidisciplinary Assessment (Behavioral)
Outcomes
Primary Outcomes
Health literacy through the use of Health Literacy Questionnaire - HLQ.
Time Frame: From enrollment to the end of treatment at 6 months.
The HLQ (Osborne et al.,2013) consists of 9 scales representing 9 dimensions of health literacy: Feeling understood and supported by healthcare providers; Having sufficient information to manage my health;Actively managing my health;Social support for health;Appraisal of health information;Ability to actively engage with healthcare providers;Navigating the healthcare system;Ability to find good health information;Understand health information well enough to know what to do. Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The scoring of the HLQ is 9 scale scores, calculated by averaging the item scores within each scale with equal weighting. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy, with higher scores meaning greater health literacy. For Scales 1 to 5, the score range is between 1 and 4 (4 response options). For Scales 6 to 9, the score range is between 1 and 5 (5 response options).
Health literacy through the use of Health Literacy Questionnaire - HLQ.
Time Frame: From enrollment to the end of treatment at 6 months.
The HLQ (Osborne et al.,2013) consists of 9 scales representing 9 dimensions of health literacy: Feeling understood and supported by healthcare providers; Having sufficient information to manage my health;Actively managing my health;Social support for health;Appraisal of health information;Ability to actively engage with healthcare providers;Navigating the healthcare system;Ability to find good health information;Understand health information well enough to know what to do. Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The scoring of the HLQ is 9 scale scores, calculated by averaging the item scores within each scale with equal weighting. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy, with higher scores meaning greater health literacy. For Scales 1 to 5, the score range is between 1 and 4 (4 response options). For Scales 6 to 9, the score range is between 1 and 5 (5 response options).
Secondary Outcomes
- Knowledge about diabetes.(From enrollment to the end of treatment at 6 months.)
- Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus(From enrollment to the end of treatment at 6 months.)
- Glycosylated Hemoglobin(From enrollment to the end of treatment at 6 months.)
- Health conditions(From enrollment to the end of treatment at 6 months.)
- Health conditions(From enrollment to the end of treatment at 6 months.)
- Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus(From enrollment to the end of treatment at 6 months.)
- Knowledge about diabetes.(From enrollment to the end of treatment at 6 months.)
- Glycosylated Hemoglobin(From enrollment to the end of treatment at 6 months.)
Investigators
Ernanda Mezaroba
PhD student
Federal University of Rio Grande do Sul