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The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial.

ABSTRACT:

Background

Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS.

Methods

A cluster-randomized controlled trial-analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the province of Salzburg. The DMP "Therapie-Aktiv" was implemented in the intervention group, and controls received usual care. Outcome measure was a change in EQ-VAS after 12 months. For comparison of rates, we used Fisher's Exact test; for continuous variables the independent T test or Welch test were used. In the multilevel modeling, we examined various models, continuously adding variables to explain the variation in the dependent variable, starting with an empty model, including only the random intercept. We analysed random effects parameters in order to disentangle variation of the final EQ-VAS.

Results

The EQ-VAS significantly increased within the intervention group (mean difference 2.19, p?=?0.005). There was no significant difference in EQ-VAS between groups (mean difference 1.00, p?=?0.339). In the intervention group the improvement was more distinct in women (2.46, p?=?0.036) compared to men (1.92, p?=?0.063). In multilevel modeling, sex, age, family and work circumstances, any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence final EQ-VAS, while DMP does not. The final model explains 28.9% (EQ-VAS) of the total variance. Most of the unexplained variance was found on patient-level (95%) and less on GP-level (5%).

Conclusion

DMP "Therapie-Aktiv" has no significant impact on final EQ-VAS. The impact of DMPs in type 2 diabetes on HRQoL is still unclear and future programmes should focus on patient specific needs and predictors in order to improve HRQoL.Trial registration Current Controlled trials Ltd., ISRCTN27414162.

SUBMITTER: Panisch S

PROVIDER: S-EPMC5892002 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial.

Panisch Sigrid S Johansson Tim T Flamm Maria M Winkler Henrike H Weitgasser Raimund R Sönnichsen Andreas C AC

Diabetology & metabolic syndrome 20180410

<h4>Background</h4>Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS.<h4>Methods</h4>A cluster-randomized controlled trial-analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the prov ...[more]

PMID: 29643940

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Project description:BackgroundAn increasing number of patients in hospital have diabetes, with most of them cared for by non-specialist staff. The effect of diabetes education for staff on patient outcomes, as well as the most effective method of staff education is unclear. Therefore, the aim of this study was to compare diabetes outcomes in medical wards where nursing staff were offered one face-to-face (F2F) session followed by access to online education (online), F2F education only, or standard care (control).MethodsWe conducted a pilot cluster randomised controlled trial involving 16-weeks baseline/rollout followed by a 28-week post-intervention period across three medical wards (clusters) in a Sydney Teaching Hospital. The online ward provided an online competency-based diabetes education program and 1-h F2F teaching from a diabetes nurse educator (DNE), the F2F ward provided four separate 1-h teaching sessions by a DNE, with no additional sessions in the control ward. The primary outcome was length of stay (LOS); secondary outcomes included good diabetes days (GDD), hypoglycaemia and medication errors. Poisson and binary logistic regression were used to compare clusters.ResultsStaff attendance/completion of ≥ 2 topics was greater with online than F2F education [39/48 (81%) vs 10/33 (30%); p < 0.001]. Among the 827/881 patients, there was no difference in LOS change between online [Median(IQR) 5(2-8) to 4(2-7) days], F2F [7(4-14) to 5(3-13) days] or control wards [5(3-9) to 5(3-7) days]. GDD improved only in the online ward 4.7(2.7-7.0) to 6.0(2.3-7.0) days; p = 0.038. Total patients with hypoglycaemia and appropriately treated hypoglycaemia increased in the online ward.ConclusionsThe inclusion of online education increased diabetes training uptake among nursing staff. GDD and appropriate hypoglycaemia management increased in the online education wards.Trial registrationProspectively registered on the Australia New Zealand Clinical Trials Registry (ANZCTR) on 24/05/2017: ACTRN12617000762358 .

Project description:To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care.Pragmatic cluster randomised controlled trial (RCT).Community Health Stations (CHSs) in Fengtai district, Beijing, China.Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation.Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups.Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures.At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI -0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference -2.38, 95% CI -4.64 to -0.12, p=0.039) and systolic BP (adjusted difference -3.57, 95% CI -6.08 to -1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol.In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China.ISRCTN01010526; Pre-results.

Project description:OBJECTIVE:To translate an informed shared decision-making programme (ISDM-P) for patients with type 2 diabetes from a specialised diabetes centre to the primary care setting. DESIGN:Patient-blinded, two-arm multicentre, cluster randomised controlled trial of 6 months follow-up; concealed randomisation of practices after patient recruitment and acquisition of baseline data. SETTING:22 general practices providing care according to the German Disease Management Programme (DMP) for type 2 diabetes. PARTICIPANTS:279 of 363 eligible patients without myocardial infarction or stroke. INTERVENTIONS:The ISDM-P comprises a patient decision aid, a corresponding group teaching session provided by medical assistants and a structured patient-physician encounter.Control group received standard DMP care. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary endpoint was patient adherence to antihypertensive or statin drug therapy by comparing prescriptions and patient-reported uptake after 6 months. Secondary endpoints included informed choice, risk knowledge (score 0-11 from 11 questions) and prioritised treatment goals of patients and doctors. RESULTS:ISDM-P: 11 practices with 151 patients; standard care: 11 practices with 128 patients; attrition rate: 3.9%. There was no difference between groups regarding the primary endpoint. Mean drug adherence rates were high for both groups (80% for antihypertensive and 91% for statin treatment). More ISDM-P patients made informed choices regarding statin intake, 34% vs 3%, OR 16.6 (95% CI 4.4 to 63.0), blood pressure control, 39% vs 3%, OR 22.2 (95% CI 5.3 to 93.3) and glycated?haemoglobin, 43% vs 3%, OR 26.0 (95% CI 6.5 to 104.8). ISDM-P patients achieved higher levels of risk knowledge, with a mean score of 6.96 vs 2.86, difference 4.06 (95% CI 2.96 to 5.17). In the ISDM-P group, agreement on prioritised treatment goals between patients and doctors was higher, with 88.5% vs 57%. CONCLUSIONS:The ISDM-P was successfully implemented in general practices. Adherence to medication was very high making improvements hardly detectable. TRIAL REGISTRATION NUMBER:ISRCTN77300204; Results.

Project description:OBJECTIVE:To determine the effectiveness of a theoretically based and individually tailored, text message based, diabetes self management support intervention (SMS4BG) in adults with poorly controlled diabetes. DESIGN:Nine month, two arm, parallel randomised controlled trial. SETTING:Primary and secondary healthcare services in New Zealand. PARTICIPANTS:366 participants aged 16 years and over with poorly controlled type 1 or type 2 diabetes (HbA1c ?65 mmol/mol or 8%) randomised between June 2015 and November 2016 (n=183 intervention, n=183 control). INTERVENTIONS:The intervention group received a tailored package of text messages for up to nine months in addition to usual care. Text messages provided information, support, motivation, and reminders related to diabetes self management and lifestyle behaviours. The control group received usual care. Messages were delivered by a specifically designed automated content management system. MAIN OUTCOME MEASURES:Primary outcome measure was change in glycaemic control (HbA1c) from baseline to nine months. Secondary outcomes included change in HbA1c at three and six months, and self efficacy, diabetes self care behaviours, diabetes distress, perceptions and beliefs about diabetes, health related quality of life, perceived support for diabetes management, and intervention engagement and satisfaction at nine months. Regression models adjusted for baseline outcome, health district category, diabetes type, and ethnicity. RESULTS:The reduction in HbA1c at nine months was significantly greater in the intervention group (mean -8.85 mmol/mol (standard deviation 14.84)) than in the control group (-3.96 mmol/mol (17.02); adjusted mean difference -4.23 (95% confidence interval -7.30 to -1.15), P=0.007). Of 21 secondary outcomes, only four showed statistically significant improvements in favour of the intervention group at nine months. Significant improvements were seen for foot care behaviour (adjusted mean difference 0.85 (95% confidence interval 0.40 to 1.29), P<0.001), overall diabetes support (0.26 (0.03 to 0.50), P=0.03), health status on the EQ-5D visual analogue scale (4.38 (0.44 to 8.33), P=0.03), and perceptions of illness identity (-0.54 (-1.04 to -0.03), P=0.04). High levels of satisfaction with SMS4BG were found, with 161 (95%) of 169 participants reporting it to be useful, and 164 (97%) willing to recommend the programme to other people with diabetes. CONCLUSION:A tailored, text message based, self management support programme resulted in modest improvements in glycaemic control in adults with poorly controlled diabetes. Although the clinical significance of these results is unclear, the findings support further investigation into the use of SMS4BG and other text message based support for this patient population. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12614001232628.

Project description:BackgroundFollowing the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines.MethodsThe study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations.ResultsPatients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these.ConclusionThis study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality.Trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Project description:IntroductionThere is little evidence on the impact of livelihood interventions amongst people with disabilities. Effective programmes are critical for reducing the heightened risk of poverty and unemployment facing persons with disabilities. STAR+ is a skills development and job placement programme targeted to out-of-school youth with disabilities (ages 14-35) living in poverty. It is a disability-targeted adaptation to an existing, effective intervention (STAR), which has been designed to address barriers to decent work for people with disabilities. This protocol describes the design of a cluster randomised controlled trial of STAR+ in 39 of the 64 districts of Bangladesh.MethodsBRAC has identified 1500 youth with disabilities eligible for STAR+ across its 91 branch offices (typically a geographical areas covering about 8 km radius from local BRAC office) catchment areas (clusters). BRAC has limited funding to deliver STAR+ and so 45 of the 91 branches have been randomly allocated to implement STAR+ (intervention arm). The remaining 46 branches will not deliver STAR+ at this time (control arm). Participants in the control-arm will receive usual care, meaning they are free to enrol in any other livelihood programmes run by BRAC or other organisations including standard STAR (being run in 15 control branches). The cRCT will assess the impact of STAR+ after 12 months on employment status and earnings (primary outcomes), as well as poverty, participation and quality of life (secondary outcomes). Analysis will be through intention-to-treat, with a random mixed effect at cluster level to account for the clustered design. Complementary qualitative research with participants will be conducted to triangulate findings of the cRCT, and a process evaluation will assess implementation fidelity, mechanisms of impact and the role of contextual factors in shaping variations in outcomes.DiscussionThis trial will provide evidence on the impact of a large-scale, disability-targeted intervention. Knowledge on the effectiveness of programmes is critical for informing policy and programming to address poverty and marginalisation amongst this group. Currently, there is little robust data on the effectiveness of livelihood programmes amongst people with disabilities, and so this trial will fill an important evidence gap.Trial registrationThis study has been registered with the Registry for International Development Impact Evaluations, (RIDIE Study ID: 6238114b481ad ) on February 25, 2022, and the ISRCTN Registry (ID: ISRCTN15742977 ).

Dataset Information

The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial.

Background

Methods

Results

Conclusion

Publications

The impact of a disease management programme for type 2 diabetes on health-related quality of life: multilevel analysis of a cluster-randomised controlled trial.

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