The results of this study show that the integrated multidisciplinary geriatric rehabilitation programme for older patients with stroke had no significant effect on the primary outcome daily activity as compared to usual care. With regard to the secondary outcomes, the programme showed favourable effects on the patients’ outdoor autonomy and the perceived care burden of their informal caregivers. For the other secondary outcomes, no significant intervention effects were observed.
The lack of effect of the programme on daily activity and most secondary outcome measures might be explained by several reasons. First, the process evaluation which was performed alongside the trial, revealed that part of patients and informal caregivers did not receive all key elements of the programme25. Although almost all patients formulated rehabilitation goals, the GAS method was only used among two thirds of the patients. In addition, the percentage of therapy sessions performed in the patients’ home environment was lower than planned, and only about a quarter of the patients and informal caregivers attended the education sessions. Furthermore, the self-management training was considered by the care professionals as rather complex and difficult to apply for frail older persons, because it was complicated for the patients to develop and carry out action plans by themselves 25. As it is widely recognised that in complex interventions often not all aspects of the intervention are completely performed according to protocol and that adaptation to local circumstances may be necessary26, it is important to improve the feasibility of the integrated programme by tailoring the goal attainment scaling, self-management training and education sessions more optimally to the population of frail older stroke patients25. In addition the training of care professionals in conducting the programme could be improved. However, despite this, the majority of patients, informal caregivers and care professionals indicated the beneficial aspects of the programme 25.
Second, a review of Fens and colleagues27 performed in 2013 evaluating the effectiveness of multidisciplinary interventions for stroke patients living in the community after being discharged home after hospitalization or inpatient rehabilitation, showed that none of the 11 studies that assessed daily activities reported a favourable effect of the intervention on this outcome. Although these multidisciplinary interventions included different combinations of elements, it clearly shows that improving daily activity among community living stroke patients is very complex, which is also confirmed by the results of our trial.
Based on our results, the increased level of autonomy outdoors of the patients receiving the programme, seems to indicate that despite the lack of increase in the actual frequency of daily activity as measured by the FAI, the level of (outdoor) activities is more in accordance with the needs and wishes of the patients. An explanation for this finding could be that the self-management component of the programme may have improved the coping skills of patients and their informal caregivers, and helped them to have more realistic expectations about the patients’ outdoor activities. The increase in autonomy related to outdoor activities, is an important finding, as De Graaf and colleagues emphasised the need to pay more attention to the social participation of stroke survivors aged over 70 years, since more restrictions in participation were perceived in comparison to younger stroke survivors one year after stroke28. Furthermore, increased attention for participation may also contribute to preventing depressive symptoms after stroke29.
With regard to the informal caregivers, the integrated programme resulted in a significant reduction in the perceived care burden of the informal caregiver. This may indicate that elements of the integrated programme, such as consultation with the stroke coordinator and stroke education, may support informal caregivers in accomplishing their supporting role. This is in accordance with the results of a review of Visser-Meily and colleagues30 who concluded that counselling programs which focus on the problems of the informal caregiver, instead of (only) on the problems of the patients, appear to have the most favourable outcomes. In our programme, the problems and experiences of the informal caregiver were explicitly addressed in different modules.
This study is one of few studies that focusses on improving stroke rehabilitation and aftercare for frail older stroke patients and their informal caregivers. However, this study has several limitations. First, we did not reach our inclusion goal of 256 patients, although we took all possible and necessary actions (i.e. extending inclusion period, extending the number of nursing homes) to increase the number of patients. This may have underpowered our multilevel analyses. However, the difference between intervention and usual care group on our primary outcome daily activity is too limited to expect that including the intended number of patients would have resulted in a statistically significant effect on our primary outcome. However, for the psychosocial functioning subscale of the Stroke Specific Quality of life scale (p = .054) accounts that a higher power may have resulted in a statistical significant favourable effect for patients in the intervention group on this subscale.
Second, because we randomised on patient level and not on nursing home level, care professionals treated both people in the intervention group and usual care group. Therefore, it is possible that treatment for persons in the usual care group was contaminated with elements of the programme which may have led to an underestimation of the effects of the programme. Although a number of elements of the programme were exclusively available for persons in the intervention group (such as the meetings with the stroke care coordinator, the multidisciplinary outpatient rehabilitation, and the stroke education course), it is still possible that other elements of the intervention were also applied among persons in the usual care group. However, we have tried to reduce this risk of contamination by emphasizing during the training of the care professionals that the programme elements should exclusively be applied in the intervention group. In addition we repeatedly checked whether contamination has occurred during regular visits of the research team to the participating organisations. During these visits care professionals confirmed that the intervention was only applied to persons in the intervention group. Furthermore, after the intervention period, we checked during a group interview with a sample of the participating care professionals whether contamination had occurred, which was not the case according to the care professionals.
Third, patients, caregivers and care professionals could not be blinded for treatment allocation, which might have created some bias. However, in order to reduce the risk of any additional bias, the outcome measurements were performed by research assistants who were blinded for treatment allocation, and the same accounts for the statistical analyses.
Fourth, the baseline measurement of the FAI was based on the activity level of patients three months before stroke occurred, as estimated by the patient. It is possible that this resulted in recall bias. However, it is likely that this accounts for patients in both the usual care and intervention group, which makes it unlikely that is has influenced our results.