Recruiting People Living with Dementia to Research Studies
Following the National Dementia Strategy and the Government’s 2020 Dementia Challenge dementia is a priority area for NIHR research funding with a target of increasing the numbers of participants with dementia into clinical research trials to 10% of this patient group. The NIHR has been supporting recruitment of people living with dementia through the NIHR Join Dementia Research register, the ENRICH Engaging Research in Care Homes network and the NIHR Clinical Research Network DeNDRoN. Focused funding calls are also increasing the breadth of research and increasing capacity in this area. Recruiting people living with dementia to research studies however can be challenging. This paper discusses what researchers need to consider when planning a study involving patients with dementia.
Many people with dementia will not have capacity to give informed consent to take part in research. The Mental Capacity Act 2005 (MCA) governs how we decide whether a patient has capacity. The MCA is a very clear piece of legislation and before conducting research involving patients living with dementia, you must become familiar with its content, particularly sections 30 to 34 which cover research. Your knowledge of the act needs to be demonstrated in any funding or research ethics application.
Establishing capacity in an individual is a two stage process, with the first stage being a question of whether there is an impairment or disturbance in the functioning of the person’s mind or brain. Everyone with dementia will answer yes to this question, however it is not acceptable to assume everyone with dementia lacks capacity, that a particular score on a cognitive test means lack of capacity or to ask the nurse if the patient has capacity. The capacity assessment is related to the decision being made, there is no general state of ‘not having capacity’.
For everyone with dementia the second stage of the test needs to be considered. This asks whether the person can:
i) Understand information about the decision to be made.
The MCA states that information must be provided in a format the patient can understand. NHS trust and University pro-forma participant information sheets are often very long and are unlikely to be understood by a patient with cognitive impairment. One page summaries of the participant information sheet are effective as is using pictures to support communication of the research. Deafness can easily be mistaken for lack of understanding. Make sure the patient is using their hearing aid before giving information. Purchasing a hearing device to use during recruitment is an effective way of improving communication with patients. Make sure infection control have approved the device to be shared between participants and the cleaning arrangements necessary.
As with all research, it is important to get service users (patients and their carers) to review patient facing documentation to ensure it is understandable and that jargon is avoided. Produce patient information sheets in sufficiently large font size as to be easily read.
ii) Retain the information in their mind.
The patient only needs to retain the information long enough to make a decision. Forgetting the information from a previous visit is not evidence of lack of capacity.
i) Use or weigh-up the information as part of the decision process.
It is important to actively test whether the patient has understood and considered the information you have given them. This can be done by asking the patient to tell you what the study involves and exploring with the patient whether they want to take part or not. This can be difficult, but try and assess if there is evidence of logical reasoning.
ii) Communicate their decision.
Many people with dementia have problems with communication, where this is the case, all efforts to help the person communicate should be made before deciding they cannot communicate.
If the answer is no to any of the above questions, then they do not have capacity to consent. Usually, it is clear whether a patient does or does not have capacity to consent to research. However, at times it can be difficult. Remember that there is always a presumption of capacity and the person has to be given all appropriate help before concluding that they cannot make their own decision. Sometimes getting a second opinion can help.
Where a patient lacks capacity, the researcher must take reasonable steps to identify an unpaid carer who can be consulted on to establish whether the patient would have wanted to take part in the research. This is usually a close family member, but could be a friend or neighbour. The carer will be asked for advice on whether the patient should take part in the project and what in their option the patient’s wishes and feelings about taking part in the project would be if the patient had capacity in relation to this matter. If an unpaid carer cannot be identified, then another person can be nominated as consultee, provided that they have no connection with the research project. In Scotland, if the patient lacks capacity, you must get consent from a guardian or welfare attorney who has power to consent to the adult’s participant in research. If there is no such person, then consent is given from the person’s nearest relative.
Depending on the context of your research study, you will need to make efforts to identify and meet with family carers. Many family carers are sons and daughters of the person living with dementia. They may work, not live close by or have other caring commitments. You will need to work in a flexible way to arrange a time to meet them. This can often involve working at weekends and evenings. When you recruit researchers, consider putting into their contract flexible working hours. Bear in mind that, depending on the setting you are recruiting from, family may be under considerable strain. In hospital their priority may be to talk to the healthcare professionals. You will need to factor in sufficient time for the appointment. However, often research is a welcome diversion for families.
Irrespective of capacity, it is important to respect the rights of the cognitively impaired patient to refuse to do research. If the participant, shows signs of distress related to the research procedures, they should be stopped. In some settings, and for some research distress is commonly seen in patients with severe dementia. It is important to differentiate between general distress and distress that is directly caused by the researcher. It may be appropriate to leave and return later to complete research procedures if distress is shown.
It is important to note that the MCA states that to approve research involving patients who lack capacity there ‘must be reasonable grounds for believing that research of comparable effectiveness cannot be carried out if the project has to be confined to, relate only to, person who have capacity to consent to take part in it’. If there is no reason to believe that cognitively impaired patients will respond differently to a treatment than cognitively intact patients, then they shouldn’t be included in the research. This is a question that NHS research ethics committees and NIHR funding committees will actively consider when approving a study. However, often it is the case that people with dementia are affected differently by treatments and it is not ethical to exclude them from research because of their capacity.
Useful documents on recruiting adults lacking capacity to research are available at: