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Hautzinger 2007 (Continued) language, temporary increased caregiver burden because of an acute illness (greater than repetition of the screening after such an episode of increased burden), involved in another clinical trial of interventions for caregivers (non-drug study) Interventions Intervention group: telephone-based problem-solving training over 12 months. It comprises 2 home visits (after randomisation and month 3) and regular telephone contacts with decreasing frequency over 12 months: month one: weekly; months 2 to 3: biweekly; months 4 to 12: monthly, plus up to 4 additional optional contacts The problem-solving procedure is structured into the following 6 steps using different cognitive-behavioural techniques like cognitive restructuring and communication skill training according to a fixed intervention manual: problem definition and facts, optimism and orientation, goal-setting, generation of alternatives, decision-making, implementation and verification. For initial problem orientation a card-sorting procedure with 40 cards is used. The intervention is delivered by a psychologist Intervention and comparator group: all participants receive a monthly information letter by post on caregiving or stroke-related issues (i.e. caregiver rights, nutrition, relaxation techniques) over 1 year Interventions and assessments are delivered by different teams; the assessment team is blinded to the different groups by the study centre. Due to communication of their status by the participants a complete blinding is probably not possible Outcomes Primary outcomes: 1. Subjective caregiver burden (Sense of Competence Questionnaire (SCQ)) 2. Caregiver depression (the Centre for Epidemiological Studies Depression scale (CES-D)) 3. Total costs of formal and informal care 4. Indirect costs Measured at: T0 (Agreement) primary and secondary outcomes T1 (3.5 months after T0) primary and secondary outcomes T2 (12 months after T0) primary and secondary outcomes T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates Secondary outcomes: 1. Ability of social problem-solving 2. Social activities 3. Social support 4. Subjective physical symptoms 5. Burden of behavioural symptoms 6. Subjective health-related quality of life 7. Qualitative analysis of caregiver burden with description of main problem areas with the card set 8. Institutionalisation rates of care recipients over a prolonged observational period Measured at: T0 (Agreement) primary and secondary outcomes T1 (3.5 months after T0) primary and secondary outcomes T2 (12 months after T0) primary and secondary outcomes T3 (24 months after T0) and T4 (36 months after T0) institutionalisation rates Starting date 1 March 2007 Contact information Professor Martin Hautizinger, Abteilung für Klinische Psychologie und Entwicklungspsychologie, Universität Tübingen, Christophstr. 2, Tübingen, Germany hautzinger@uni-tuebingen.de Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 44
Hautzinger 2007 (Continued) Notes MAPSS 2006 Trial name or title Improving stroke recovery in Maori and Pacific people and their families (MAPSS) Methods Multicentre RCT Participants Inclusion criteria: stroke using World Health Organization definition ’rapidly developing symptoms and/or signs of focal, and at times global, loss of cerebral function, with symptoms lasting longer than 24 hours or leading to death with no apparent cause other than that of vascular origin; self identified ethnicity as Maori, Samoan, Tongan, Cook Island Maori, Niuean, Fijian; aged ≥18 Exclusion criteria: cannot give informed consent, living within institution after stroke, subarachnoid haemorrhage Interventions Participants randomised to receive 1 of 3 interventions or a control. Intervention A: educational video lasting 80 minutes; Intervention B: goal-setting exercise lasting 90 minutes; Intervention C: both the video and the goal-setting exercise lasting 170 minutes Comparator intervention: written pamphlet will take 30 minutes to read Outcomes Primary outcome at 6 and 12 months: short form 36 (SF-36) Secondary outcomes at 6 and 12 months: carer strain index, mortality, mental wellness (using Hua Oranga), Frenchay Activity Index, Barthel Index, Charleson Comorbidities Index, discrimination (EDQ) Starting date 1 February 2006 Contact information Dr Matire Harwood, c/o Medical Research Institute of New Zealand (MRINZ) PO Box 10055 Wellington, New Zealand Tel: +64 4 4729112 Email: matire.harwood@mrinz.ac.nz Notes Markle-Reid 2007 Trial name or title The comparative acceptability, safety, effects and expense of specialized, integrated, and interdisciplinary community rehabilitation for stroke survivors and their caregivers Methods Type: interventional Study design: allocation randomised Control: active control Endpoint classification: efficacy study Intervention model: parallel assignment Masking: double-blind (investigator, outcomes assessor) Primary purpose: treatment Non-pharmacological interventions for caregivers of stroke survivors (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 45
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