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临床试验/NCT05695443
NCT05695443已完成不适用

Oral Health in Prison: a Randomized Controlled Study of the Effect of Motivational Interview on Improving Prisoners' Oral Health

Oral Health Center of Expertise Rogaland, Norway2 个研究点 分布在 1 个国家目标入组 328 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
328
试验地点
2
主要终点
Changes from baseline Mucosal-plaque index (MPS)

研究概览

简要总结

This study investigates the effects of an intervention based on Motivational Interviewing (MI) on oral hygiene, oral cleaning routines, and attitudes toward own oral health of prisoners in Norway. Motivational Interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change. All prisoners in the study undergo an oral examination to establish a baseline of oral health and a comprehensive questionnaire to identify risk factors and their attitudes towards their oral health and oral treatment. Norwegian-speaking prisoners are then randomized into either a treatment or control group. In the treatment group, dental staff initiate a conversation with the prisoner based on techniques from MI. Both groups finally receive a toilet bag with basic equipment to regularly clean their teeth. After 4 weeks and 12 weeks, prisoners are invited back for another oral examination and a follow-up questionnaire, to measure changes in oral hygiene, oral cleaning routines, and attitude toward their oral health. At four weeks a screening of general learning difficulties using the validated screening tool The Hayes Ability Screening Index (HASI) will be conducted. If the intervention proves to be an effective tool in improving oral hygiene, oral cleaning routines, and/or attitude towards own oral health, it can serve as an alternative proactive approach to improve the oral health of a vulnerable group in society. If the improvements in oral hygiene and oral cleaning routines are long-lasting, this may in turn lead to a reduced need for oral treatment. An improved attitude towards own oral health may, together with other rehabilitation programs in prison, improve the prisoner's self-esteem and chances to successfully returning to society after having served their prison sentence.

详细描述

Study design and procedures:

The geographic region of this study is Rogaland County in the southwestern part of Norway. There are four prisons in Rogaland County, all of which are included in the study. Three prisons are categorized as high-security prisons, and one is categorized as a low-security prison. The main difference between high and low-security prisons is the level of security measures, as prisoners in low-security prisons are allowed to move more freely within the prison. The low-security prison is mainly used for less serious criminal offenses, with a sentence time of between six months and two years. Those convicted to less than six months can apply to serve the time with an ankle bracelet, whereas those convicted for more than two years start serving in a high-security prison. However, many high-security prisoners are transferred to low-security prisons to serve the final part of their sentence. Hence, the population across prisons is likely to vary due to the severity of the criminal offense they have committed, especially across high and low-security prisons. However, as those with the least serious criminal offenses serve time with an ankle bracelet, and those with more severe convictions often serve the final part of their sentence in a low-security prison, the populations may not be that different from each other.

Recruitment procedures:

Recruitment is done somewhat differently across prisons, and different for those already imprisoned at the time of the start of data collection and those arriving in the prison during the data collection period. For those already imprisoned at the start of data collection, they are either informed about the study by prison officers or dental staff. This process should originally be done exclusively by prison officers, but capacity constraints forced us to use our own staff in two of the prisons. The information given is the same across all prisons, based on an information letter, which is also distributed to the prisoners. They then give their preliminary consent to participate within a couple of days after being informed.

Those who arrive at the prison during the period of data collection are either informed about the study by prison officers or prison health workers during their first days in prison. Again, recruitment is done depending on the capacity of prison officers. In one prison, the dental staff was involved in the recruitment process. The information provided is the same as for those already imprisoned, and they receive the same information letter. Prisoners give their preliminary consent to participate within a couple of days.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Prisoners are not informed whether they are in the treatment or control group and are therefore blind to treatment status. Dental staff is blind to prisoners' treatment status at the first oral examination and questionnaire. The prisoner's treatment status is revealed just after this. Hence, dental staff collects data prior to knowing the prisoners' treatment status, and only learns this when they start the MI-based conversation. When prisoners are back at T1 and T2 for follow-up oral examinations and questionnaires, dental staff might still remember whether the prisoner was treated or not. To partially account for potential bias in the oral examination (assessment of plaque and mucosal inflammation), there are two independent assessments of this at T1 and T2.

入排标准

性别
All
接受健康志愿者

入选标准

  • Everyone serving time in one of the four prisons during the period of the study (November 2021 to June 2023)
  • Sufficient Norwegian language

排除标准

  • Insufficient Norwegian language

结局指标

主要结局

Changes from baseline Mucosal-plaque index (MPS)

时间窗: Baseline- 4 weeks-12 weeks

A four-point plaque score (PS) and a four-point mucosal score (MS). For the PS, score of 1 suggests no visible plaque, score of 2 suggests plaque is barely visible, score of 3 suggests a moderate amount of plaque, and score of 4 suggests large amount of plaque almost covering the whole surface of teeth. For the MS, score of 1 suggests normal mucosal, score of 2 suggests mild inflammation, score of 3 suggests medium inflammation, and score of 4 suggests strong inflammation. For both scores, if in doubt between 1 and 2, they are instructed to score 1. If in doubt between 3 and 4, they are instructed to score 4. The index is designed to evaluate oral health and oral hygiene in groups of individuals. This makes it a suitable index to be used when conditions are not optimal to assess the patient. In prison, dental staff have limited equipment and poor light compared to an ordinary dental clinic. Therefore, using an index designed to be used outside of clinics was important.

次要结局

  • Questionnaire responses(Baseline- 4 weeks-12 weeks)

研究者

发起方
Oral Health Center of Expertise Rogaland, Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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