跳至主要内容
临床试验/NCT01754753
NCT01754753终止不适用

Evaluation of the Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People.

University of Sheffield2 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
157
试验地点
2
主要终点
SF-36 Mental Health Dimension

研究概览

简要总结

The National Institute for Health Research commissioned this research with the following research question: "What is the relative effectiveness and cost effectiveness of home based support programmes in improving the mental wellbeing of older people living in their own homes?"

The project will evaluate whether telephone friendship groups, delivered by the voluntary sector over the telephone, can improve the mental wellbeing of older people aged 75 or over.

The research will also:

  1. Identify the psychosocial and environmental factors, as well as implementation issues that may mediate or modify the effectiveness of the intervention using qualitative methods. This will include examining: 1.1. Assess voluntary sector readiness to take forward new forms of services; 1.2. The best modes of delivery of telephone support/friendship; 1.3. Assess how volunteers (facilitators) can be supported and retained; and, 1.4. The extent to which fidelity of the intervention is maintained within and across the participating organisations.
  2. Determine if there is any lasting impact upon mental wellbeing by repeat measurement with all participants 12 months following baseline measurement
  3. Examine whether there is any significant improvement on the physical dimension of the SF-36 at 6 months and 12 months, following baseline measure, for the intervention arm compared with usual care.
  4. Measure the extent of use of health and social care, and community facilities by participants over time to determine whether the intervention is cost effective compared with usual care.

详细描述

Background and study aims:

People are living longer and many experience a good old age. Unfortunately longer life is not always accompanied by health and wellbeing. Older people can become lonely, isolated and unhappy as a result of a whole number of factors such as diminished physical abilities and bereavement.

Our research programme is examining how people aged 75 years and over can be helped to retain wellbeing and not feel unhappy due to feelings of loneliness and isolation. It is examining the possible benefits of group friendship over the telephone. Telephone befriending services are usually provided through the voluntary sector and are available in a number of locations. Befriending can take place on a one-to-one basis or through small groups of people linked together by telephone (teleconferencing). A small amount of research has already been conducted into telephone befriending. It appears to provide benefit but intevestigators need evidence from more people who have experienced befriending by telephone to be able to make clear statements about whether it should be recommended.

What does the study involve? To ensure that the research is thorough investigators want to recruit and involve 248 older people aged 75 years and over who live in Sheffield. It will take us over a year to recruit the number of older people investigators need as the befriending services can only accommodate a certain number of people at any one time.

The main method of inviting people to participate in the research is through letters of invitation from primary care. However investigators are also using other ways to get the information to those who might be interested such as giving talks at community venues and asking health and social care professionals to identify people who they think might benefit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 75 years or over
  • Good cognitive function, defined as Six Cognitive Impairment Test Brooke P, Bullock R, 1999) score of 7 or under;
  • Living independently (including those who are co-resident with others) or in sheltered/ extra care housing;
  • Able to understand and converse in English.

排除标准

  • Aged 74 years or younger
  • 6CIT score of 8 or more
  • In residential/ nursing care homes
  • Unable to understand and converse in English
  • Unable to converse on the telephone with assertive technology
  • Already receiving a telephone intervention

结局指标

主要结局

SF-36 Mental Health Dimension

时间窗: SF36 at 6 months

The Short Form 36 Health Survey Questionnaire (SF-36) is a 36 item scale, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.

次要结局

  • Patient Health Questionnaire (PHQ-9)(PHQ-9 at 6 months)
  • De Jong Loneliness Scale(De Jong at 6 months)
  • ONS Wellbeing Question(ONS wellbeing at 6 months)
  • General Perceived Self Efficacy (GSE) Scale(GSE at 6 months)
  • Other Dimensions of the SF-36 (and Specifically Physical Health)(SF36 other dimensions at 6 months)
  • EQ-5D for Health Economic Analysis(EQ-5D at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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