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临床试验/NCT04946292
NCT04946292招募中不适用

Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly

National University of Singapore1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2022年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
440
试验地点
1
主要终点
Increment of coronal caries

研究概览

简要总结

Ageing of the world's population is accelerating. Despite the health challenges they face, older people should not be stereotyped as frail and dependent. Healthy ageing is possible if adequate care is provided and effective intervention is delivered for healthy living. Common oral diseases (dental caries and periodontal diseases) are determined to a great extent by health behaviours (diet and oral hygiene) and are controllable through effective interventions. Hence, this study aims to test the theoretical models for health promotion, develop theory-derived intervention, and evaluate its effectiveness in improving oral health of older adults. The study hypothesis is that theory-derived intervention is more effective than conventional health education in eliciting positive behaviours and controlling oral diseases in older adults.

详细描述

This study targets older adults and aims to (i) test the explanatory power of the dominant theoretical models/ frameworks, (ii) develop theory-derived intervention, and (iii) evaluate the effectiveness of the theory-derived intervention. The hypothesis is that theoretical-derived intervention is more effective than conventional health education in improving oral health behaviours and preventing oral diseases among older adults.

The sample size needed for this study was calculated by using the software G*Power version 3.1.9.2 (Franz Faul, University of Kiel, Germany). The sample size calculation was based on the primary outcomes, namely increment of coronal caries and increment of root caries, and independent t-tests for comparing means of two independent groups. A caries incidence study among the elderly reported that the mean (SD) 5-year caries incidence were 2.65 (3.14) for coronal caries and 2.21 (2.83) for root caries 17. The 2-year incidence of coronal caries and root caries were therefore estimated to be 1.06 (1.26) and 0.88 (1.13), respectively, in the control group. The effect of an intervention is considered clinically significant if it reduces the caries incidence by 40%. Based on a significance level of 5% and a power of 80%, 140 subjects per group are needed for coronal caries and 165 subjects are needed for root caries outcome measures. To take both outcome measures into account, the higher number (i.e., n=165) will be adopted. Allowing for a 25% attrition rate, 220 elderly persons will need to be recruited into each group, giving a total sample size of 440.

Each participant will be required to complete a detailed questionnaire at the initial visit through face-to-face interviews. Information on socio-demographic background (gender, age, education level, past occupation, and type of housing) and oral health behaviours (diet, toothbrushing and dental flossing) will be collected. The questionnaire will also include the scales for three dominant theoretical models, namely, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT).

The theoretical model that best explains the health behaviours will be selected for designing oral health intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). Relevant medical literatures will be referred to. The needs, interest, and health literary of the target group (i.e. older adults of varied social and educational backgrounds) will be taken into full consideration. The intervention will be tested in a small group of 15-20 older people to ensure its relevance, practicality, and acceptability.

Participants will be randomly assigned to two groups, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes. The two groups will receive conventional health education and theory-derived intervention, respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
55 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 55-70 years old
  • Living in the community (alone or with family members), instead of residing in a nursing home
  • Having at least 8 natural teeth
  • No plan to immigrate in 3 years

排除标准

  • Life-threatening disease; impaired cognitive function (e.g. Alzheimer's syndrome); radiotherapy in the head and neck region

研究组 & 干预措施

Theory-derived intervention

Experimental

Questionnaire will be used including the scales for three dominant theoretical models, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours of the selected participants will be selected for designing oral health intervention.The theory-derived intervention will address the constructs/domains of the selected model(s) in the context of the three target behaviours (diet, toothbrushing and dental flossing).

干预措施: Theory-derived intervention (Behavioral)

Conventional health education

Active Comparator

Participants will be randomly assigned to the control group, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes.

干预措施: Conventional health education (Behavioral)

结局指标

主要结局

Increment of coronal caries

时间窗: From baseline to 2 years post-intervention

Number of new surfaces with coronal caries

Increment of root caries

时间窗: From baseline to 2 years post-intervention

Number of new surfaces with root caries

次要结局

  • Change in dietary behaviours (favourable/unfavourable)(From baseline to 2 years post-intervention)
  • Change in toothbrushing behaviours (favourable/unfavourable)(From baseline to 2 years post-intervention)
  • Change in flossing behaviours (favourable/unfavourable)(From baseline to 2 years post-intervention)
  • Change in oral hygiene status (plaque score)(From baseline to 2 years post-intervention)
  • Change in periodontal condition(From baseline to 2 years post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xiaoli

Associate Professor

National University of Singapore

研究点 (1)

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