Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial [ISRCTN92331982]

BACKGROUND: Depression is a prevalent disorder in chronically ill elderly persons. It may decrease quality of life, and increase functional disability, medical costs, and healthcare utilisation. Because patients may slip into a downward spiral, early recognition and treatment of depression is important. Depression can be treated with antidepressants or psychological interventions; the latter can also be applied by trained paraprofessionals. In this paper, we describe the design of the DELTA study (Depression in Elderly with Long-Term Afflictions). The first objective of the DELTA study is to evaluate the effectiveness and cost-effectiveness of a minimal psychological intervention (MPI) to reduce depression in chronically ill elderly patients. The second objective is to evaluate whether a potential effect of the MPI may differ between types of chronic illnesses. The tailor-made intervention is administered by nurses, who are trained in the principles of cognitive behavioural therapy and self-management. METHODS/DESIGN: DELTA is a two-armed randomised controlled trial, comparing MPI to usual care. A total number of 180 patients with diabetes mellitus type II (DM) and 180 patients with chronic obstructive pulmonary disease (COPD), who in addition suffer from non-severe depression, will be included in the study. In our study, non-severe depression is defined as having minor depression, mild major depression or moderate major depression. The primary outcome measure is depression using the Beck Depression Inventory. Secondary outcome measures include quality of life, daily functioning, self-efficacy, autonomy, and participation. In the economic evaluation, cost-effectiveness and cost-utility ratios will be calculated. Furthermore, a process evaluation will be carried out. Analyses will include both univariate and multivariate techniques and according to the intention to treat principle. The economic evaluation will be done from a societal perspective and data of the process evaluation will be analysed using descriptive techniques. DISCUSSION: A total number of 361 patients has been included in the study. All interventions have been administered and follow-up data will be complete in September 2006. Preliminary results from the process evaluation indicate that patients' satisfaction with the intervention is high. If this intervention proves to be effective, implementation of the DELTA intervention is considered and anticipated

Evaluating an intervention to reduce fear of falling and associated activity restriction in elderly persons: design of a randomised controlled trial [ISRCTN43792817]

BACKGROUND: Fear of falling and associated activity restriction is common in older persons living in the community. Adverse consequences of fear of falling and associated activity restriction, like functional decline and falls, may have a major impact on physical, mental and social functioning of these persons. This paper presents the design of a trial evaluating a cognitive behavioural group intervention to reduce fear of falling and associated activity restriction in older persons living in the community. METHODS/DESIGN: A two-group randomised controlled trial was developed to evaluate the intervention. Persons 70 years of age or over and still living in the community were eligible for study if they experienced at least some fear of falling and associated activity restriction. A random community sample of elderly people was screened for eligibility; those eligible for study were measured at baseline and were subsequently allocated to the intervention or control group. Follow-up measurements were carried out directly after the intervention period, and then at six months and 12 months after the intervention. People allocated to the intervention group were invited to participate in eight weekly sessions of two hours each and a booster session. This booster session was conducted before the follow-up measurement at six months after the intervention. People allocated to the control group received no intervention as a result of this trial. Both an effect evaluation and a process evaluation were performed. The primary outcome measures of the effect evaluation are fear of falling, avoidance of activity due to fear of falling, and daily activity. The secondary outcome measures are perceived general health, self-rated life satisfaction, activities of daily life, feelings of anxiety, symptoms of depression, social support interactions, feelings of loneliness, falls, perceived consequences of falling, and perceived risk of falling. The outcomes of the process evaluation comprise the performance of the intervention according to protocol, the attendance and adherence of participants, and the participants' and facilitators' opinion about the intervention. Data of the effect evaluation will be analysed according the intention-to-treat and on-treatment principle. Data of the process evaluation will be analysed using descriptive techniques