Nurse-led psychological intervention for type 2 diabetes: a cluster randomised controlled trial (Diabetes-6 study) in primary care

BackgroundSuboptimal glycaemic control in type 2 diabetes (T2D) is common and associated with psychological barriers.AimTo investigate whether it was possible to train practice nurses in six psychological skills (Diabetes-6 [D6]) based on motivational interviewing (MI) and basic cognitive behaviour therapy (CBT), and whether integrating these with diabetes care was associated with improved glycaemic control over 18 months compared with standard care.Design and settingTwo-arm, single-blind, parallel cluster randomised controlled trial in primary care.MethodAdult participants (n = 334) with T2D and persistent HbA1c ≥69.4 mmol/mol were randomised to receive 12 sessions of either the D6 intervention or standard care over 12 months. Practice nurses were trained in the six psychological skills and their competencies were measured by standardised rating scales. Primary outcome was a change in HbA1c level at 18 months from randomisation. Secondary outcomes were changes in systolic and diastolic blood pressure, body mass index, waist circumference, depressive symptoms, harmful alcohol intake, diabetes-specific distress, and cost-effectiveness.ResultsUsing intention-to-treat analysis, there was no significant difference between D6 intervention and standard care in HbA1c (mean difference −0.79 mmol/mol, 95% confidence interval [CI] = −5.75 to 4.18) or for any of the secondary outcomes. The competency level of D6 nurses was below the beginner proficiency level and similar to the standard-care nurses.ConclusionTraining nurses in MI and basic CBT to support self-management did not lead to improvements in glycaemic control or other secondary outcomes in people with T2D at 18 months. It was also unlikely to be cost-effective. Furthermore, the increased contact with standard-care nurses did not improve glycaemic control.

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Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-021-01133-8 ◽

2021 ◽

Vol 18 (1) ◽

Author(s):

Russell Jago ◽

Byron Tibbitts ◽

Kathryn Willis ◽

Emily Sanderson ◽

Rebecca Kandiyali ◽

...

Keyword(s):

Physical Activity ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Control Group ◽

Cluster Randomised ◽

Secondary Outcomes ◽

Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

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Indigenous health worker support for patients with poorly controlled type 2 diabetes: study protocol for a cluster randomised controlled trial of the Mana Tū programme

BMJ Open ◽

10.1136/bmjopen-2017-019572 ◽

2018 ◽

Vol 8 (12) ◽

pp. e019572

Author(s):

Vanessa Selak ◽

Tereki Stewart ◽

Yannan Jiang ◽

Jennifer Reid ◽

Taria Tane ◽

...

Keyword(s):

Type 2 Diabetes ◽

New Zealand ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Determinants Of Health ◽

Pacific People ◽

Cluster Randomised ◽

Randomised Controlled

IntroductionType 2 diabetes mellitus (T2DM) and its complications are more common among Māori and Pacific people compared with other ethnic groups in New Zealand. Comprehensive and sustained approaches that address social determinants of health are required to address this condition, including culturally specific interventions. Currently, New Zealand has no comprehensive T2DM management programme for Māori or Pacific people.Methods and analysisThe Mana Tū programme was developed by a Māori-led collaborative of primary healthcare workers and researchers, and codesigned with whānau (patients and their families) in order to address this gap. The programme is based in primary care and has three major components: a Network hub, Kai Manaaki (skilled case managers who work with whānau with poorly controlled diabetes) and a cross-sector network of services to whom whānau can be referred to address the wider determinants of health. The Network hub supports the delivery of the intervention through training of Kai Manaaki, referrals management, cross-sector network development and quality improvement of the programme. A two-arm cluster randomised controlled trial will be conducted to evaluate the effectiveness of the Mana Tū programme among Māori, Pacific people or those living in areas of high socioeconomic deprivation who also have poorly controlled diabetes (glycated haemoglobin, HbA1c, >65 mmol/mol (8%)), compared with being on a wait list for the programme. A total of 400 participants will be included from 10 general practices (5 practices per group, 40 participants per practice). The primary outcome is HbA1c at 12 months. Secondary outcomes include blood pressure, lipid levels, body mass index and smoking status at 12 months. This protocol outlines the proposed study design and analysis methods.Ethics and disseminationEthical approval for the trial has been obtained from the New Zealand Health and Disability Ethics Committee (17/NTB/249). Findings will be presented to practices and their patients at appropriate fora, and disseminated widely through peer-reviewed publications and conference presentations.Trial registration numberACTRN12617001276347; Pre-result.

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Community groups or mobile phone messaging to prevent and control type 2 diabetes and intermediate hyperglycaemia in Bangladesh (DMagic): a cluster-randomised controlled trial

The Lancet Diabetes & Endocrinology ◽

10.1016/s2213-8587(19)30001-4 ◽

2019 ◽

Vol 7 (3) ◽

pp. 200-212 ◽

Cited By ~ 17

Author(s):

Edward Fottrell ◽

Naveed Ahmed ◽

Joanna Morrison ◽

Abdul Kuddus ◽

Sanjit Kumer Shaha ◽

...

Keyword(s):

Type 2 Diabetes ◽

Randomised Controlled Trial ◽

Mobile Phone ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Community Groups ◽

Cluster Randomised ◽

Randomised Controlled ◽

And Control

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Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034507 ◽

2020 ◽

Vol 10 (1) ◽

pp. e034507 ◽

Cited By ~ 2

Author(s):

Sofa D Alfian ◽

Rizky Abdulah ◽

Petra Denig ◽

Job F M van Boven ◽

Eelko Hak

Keyword(s):

Type 2 Diabetes ◽

Randomised Controlled Trial ◽

Antihypertensive Drugs ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Intervention Programme ◽

Cluster Randomised ◽

Randomised Controlled

IntroductionCurrent intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.Methods and analysisA cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients’ blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.Ethics and disseminationEthical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.Trial registration numberNCT04023734.

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