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The IDEMCare Study—Improving Dementia Care in Black African and Caribbean Groups: A feasibility cluster randomised controlled trial

Objective We evaluated the feasibility and acceptability of a tailored evidence‐based intervention, consisting of a leaflet and a letter, to encourage timely help‐seeking for dementia in Black elders. Methods Participating GP surgeries were randomised to send either the intervention or a control leaflet about ageing well to Black patients aged ≥50 years old without known dementia. We interviewed patients 2 weeks later about the intervention's acceptability using closed and open‐ended questions, and they completed a Theory‐of‐Planned‐behaviour questionnaire about what they would do if they developed memory problems, which they also completed 4 months later. Results Five of 26 surgeries approached agreed to invite patients. Sixty‐five patients responded, of whom 61 (93.8%) agreed to participate. At 2 weeks, we consented and interviewed 47/61 (77%), of whom 24 received the intervention, and at 4 months we followed up 43/47 (91.5%). At 2 weeks, 44/47 (93.6%) found either intervention acceptable to receive by post, including 23/24 of the intervention. Nineteen of 24 (79.2%) reported reading the intervention leaflet compared with 13/23 (56.5%) controls. The intervention leaflet made 16/24 (66.7%) think about visiting their doctor for memory problems and led 4 to help‐seeking behaviour. We calculated that 191 patients and 24 surgeries are required for an efficacy trial. Conclusions Given the intervention is acceptable, inexpensive, and unlikely to cause harm, we judge it appropriate to disseminate it without a full‐scale trial. Recruitment attainment, retention, and projected sample size calculation indicated feasibility for a larger trial.

delayed care home entry, prolonged autonomy, access to social care, and reduced crises and costs. [9][10][11] Black African and Caribbean elders (BACe) tend to seek help first from their immediate social network, including close relatives and friends, 12 and delay help-seeking from health and social care providers until crisis strikes or they can no longer cope. 4,13 Their dementia care pathway also appears to differ from that of their White counterparts, with a lesser likelihood of receiving anti-dementia medication, or taking part in research trials of novel therapies. 4 Barriers to help-seeking for dementia are diverse and include failing to identify or acknowledge symptoms, concerns about outcomes of receiving a diagnosis, conception of dutiful family care; attitudes towards service providers, ability, and willingness to divulge private or sensitive information. 7,14 Some of these are not specific to dementia, but others about the meaning of memory loss, the idea that dementia is only a disease of white women, and the outcomes of a diagnosis are. 14 UK Black adults regard memory problems as a private and stigmatising matter that should be kept in the family and find it a difficult subject to broach with their General Practitioner (GP), possibly because of being brought up with the idea that it was meritorious not to divulge these symptoms. Some even view dementia as a "White person's illness" that does not exist in the Black population. 14 As the process of help-seeking for dementia has culture specific aspects, 7 tailoring health interventions and services to cultural groups is recommended. 13,15 2 | THE PRESENT STUDY This trial was part of a larger research project with the overall aim of improving dementia care in Black African and Caribbean populations.
The first stage was a qualitative study with 50 Black adults to better understand how Black families respond to memory problems, a possible sign of dementia. 14 We used these findings to (1) develop a new intervention to facilitate timely diagnosis of dementia in BACe, and (2) evaluated its acceptability and (3) its delivery in a feasibility cluster randomised controlled trial (RCT). We also used the APEND, a validated Theoryof-Planned-behaviour (TPB) questionnaire 16 developed to evaluate intention to seek help for dementia in Minority Ethnic elders.

National Research Ethics Service Committee Cambridgeshire and
Hertfordshire gave ethics committee approval, and we obtained Research and Development (R&D) permission from the areas in which the GP practices for the RCT were located.

| Intervention
We used findings from earlier systematic reviews 6,17 and our qualitative study 14 to develop a leaflet entitled "Getting help for forgetfulness" (Appendix 1, found in the Supporting Information), tailored to overcome barriers to help-seeking specific to BACe.

Content of the leaflet
We included illustrations and anonymised quotes from Black adults whom we interviewed in the qualitative study 14 and covered the following themes: • How to overcome barriers to help-seeking for memory problems • Where to find more information and help.
We improved and refined the leaflet content, layout, and illustration through consultation with people with mild dementia recruited from memory clinics, family carers, dementia experts, clinicians, volunteers from initial focus groups and from the public, and professional graphic designers to ensure acceptability, understandability, and clarity.

Accompanying letter
We developed a personalised letter to accompany the leaflet which was addressed on each surgery's headed paper to individual patients and signed by their GP by refining a letter from previous projects. 18 The letter encouraged patients to read the leaflet as it contained information about dealing with memory problems relevant to BACe, and reassured them that receiving it was not indicative of suspicion by the GP that they, or a family member had memory problems. It distinguished potential symptoms from occasional lapses in memory by their persistence and severity and advised patients to make an appointment to see a doctor if they are worried about their memory (Appendix 2, found in the Supporting Information).

| Control intervention
We selected a leaflet of similar length and layout about keeping physically active and ageing well (Appendix 3, found in the Supporting Information), which was not specifically tailored to a Black audience or about dementia. It did not contain images of Black individuals, nor did it include quotes or address concerns specific to Black families. We

Key points
• Black elders present late to dementia services.
• We present a targeted, evidence-based, inexpensive intervention to improve timely help-seeking for dementia in Black elders.
• This intervention is feasible and acceptable.
• This pilot study provides data for future trials and resources for routine practice.
obtained written authorisation and printed copies from the relevant owner. The control leaflet was accompanied with a minimally modified version of the personalised GP letter (Appendix 4, found in the Supporting Information).

| Exploratory cluster randomised controlled trial
We aimed to evaluate feasibility of recruitment (GPs and patients), acceptability of the new intervention, and its delivery in a feasibility cluster RCT. We pre-specified that if feasible and acceptable, then ≥70% of patients who expressed an interest in the study would consent and ≥80% of those who enrolled initially would participate in the follow-up phase. We also aimed for a rating of the intervention as acceptable by ≥80% of participants. The trial was registered with the International Standard for RCT (http://www.isrctn.com/ ISRCTN67199930).

| Participants
Patients were Black African, Caribbean, and British, aged ≥50 years and were registered with one of the GP practices we had recruited.
We excluded patients who had a known diagnosis of dementia, or were being assessed for dementia, those who lacked capacity to consent to the study, and people living in a care home.

| Design
This was a multisite, parallel group, cluster randomised controlled feasibility, and acceptability trial. We aimed to recruit 5 GPs from areas of Greater London with a high density of residents from Black backgrounds based on reports from the Office for National Statistics. 19

| Procedure
We searched NHS official websites for contacts of GP practices in these areas and where we had R&D permission. We linked with the primary care research network in North Thames and South London to help with the recruitment of GP surgeries. We then approached those surgeries and asked staff to search their records for registered patients and to invite them to the study by mail. The letter of invitation sent by GP staff between November 2015 and June 2016 included information about a voucher incentive of £20 as a token of appreciation for participation and a return response slip for patients to complete with their contact details and send to the researchers if they wished to participate. The letter asked whether they would agree to participate in a study with UCL. It did not specify the research was about dementia care in Black elders (Appendix 5, found in the Supporting Information).
We telephoned patients who responded to discuss the study and sent them written information by post if they agreed to participate.
Twenty-four hours or more after they were deemed to have received the information, we asked GP staff to send them the new tailored or the control intervention depending on the group their GP practice was allocated.

| Randomisation
GP practices were randomly allocated to intervention (n = 2) or control (n = 3) group using "ralloc" procedure in Stata version 14 by an independent statistician within CLAHRC (Collaboration for Leadership in Applied Health Research and Care) North Thames who was not involved in the remainder of the trial.

| Assessment
Two weeks after the leaflet was sent out, we contacted each participant to arrange a face-to-face interview during which they completed a consent form. Participants were excluded from the study if they had not agreed to a date for interview within 4 weeks of being contacted.

Interviews
1. Participants provided sociodemographic information, including ethnicity, sex, age, religion, country of birth, year of arrival in UK, education, employment status, and marital status.

We asked all participants closed and open-ended questions about
what they thought of the intervention (or control); whether they found it acceptable to receive them in the post; whether they read them; and to provide any additional comments they had about them.
We used this information to assess acceptability by summing up their answers to "yes and no" questions and by analysing their answers to open-ended questions for rating of the intervention.

They also completed the APEND-Attitudes of People from Ethnic
Minorities to Help-Seeking for Dementia 16 TPB questionnaire and answered questions about whether the intervention influenced their attitudes towards help-seeking for memory problems from their doctor, and whether it led them to contact their GP.
The APEND questionnaire is a validated 19-item scale with each statement scored on a 7-level Likert scale from 1 (strongly disagree) to 7 (strongly agree), with higher scores denoting favourable attitudes towards help-seeking. It was developed to measure attitudes of people from minority ethnic groups to helpseeking for dementia and evaluate the impact of interventions seeking to promote intention to seek formal help for memory problems. 16 We used this to evaluate behavioural intention by summing up the 3 items of the scale measuring intention (Table 2). 4. Participants also answered questions about whether they have known, cared for, or worked with someone with dementia.

Four-month follow-up
Participants were interviewed 4 months after they received the intervention and asked to complete the APEND questionnaire again.

| ANALYSIS
We described percentages of GP practices who agreed to be randomised, patients who responded to GPs' invitations to enrol, those who consented to the study, and retention rates at follow-up. We described the demographics of the participants and classified occupation by the ONS SOC Group (2010)-Office for National Statistics Standard Occupation Classification. 20 We analysed the answers to questions about acceptability using Excel for Windows. We calculated the percentage of patients who accessed and rated the new tailored intervention and compared it with patients' reaction to the control intervention. We also calculated projected sample size for a future main trial, including the number of patients and GP surgeries to contact to reach the sample target.
Mixed effects linear models were used to assess the differences in intention to seek help between groups over time of testing.

| RESULTS
The flow of participants is shown in the consort diagram ( Figure 1). Of the 26 surgeries approached, 17 (65.4%) did not respond after 3 or more attempts and 4 (15.4%) declined to participate. The 5 (19.2%) GP practices randomised to the trial were in outer and inner London (Lambeth, Barking and Dagenham, and Ilford). There were a total of 1674 eligible registered patients, but we only sent invitation letters to 787 of these as we aimed to recruit 30 to 40 participants. We received 65 responses, of whom 93.8% (61/65) agreed to receive the intervention. Two weeks later, 77% (47/61) consented to the study at the time of first interview. Four months later, 91.5% (43/47) of participants completed the follow-up interviews. Table 1 shows and compares the demographic characteristics of the 47 patients who consented to the study according to randomisation group. Twenty-six (55.3%) participants were female, and the mean age was 57.6 (SD = 11.8) ranging from 50 to 89 years.
Nearly half (23/47, 48.9%) self-identified as African and had lived in UK an average of 30.9 years (SD = 15.5) ranging from 5 to 56 years.  responses to the open-ended questions revealed that the intervention was found to be relevant, useful, helpful, informative, and educational.

| APEND
The distribution of ratings for all items to the APEND questionnaire at 2 weeks was negatively skewed with skewness ranging between −0.853 to −2.728 (SE: 0.347) and median values between 5.00 and 7.00, suggesting favourable attitudes towards seeking help for memory problems from a doctor ( Table 2). The middle 50% of ratings fell between 4 (neutral) and 7 (strongly agree).

| RANDOMIZED CONTROLLED TRIAL
The sum and average score of ratings for intention to seek help at 2 weeks and 4 months showed no differences between intervention and control groups (

| Post-hoc analysis
Post-hoc analysis using Mann-Whitney U test of the subgroup of the 29 patients who accessed both interventions and completed both legs of the trial with exact probability measure revealed no significant differences on intention to seek help between the intervention and    control groups, at 2 weeks (mean difference of 0, U = 95.00, z = −.19, P = .877) and 4 months, (mean difference of −1.4, U = 75.50, z = −1.11, P = .296) ( Table 3).

| Cost calculation
The service support cost per GP practice was £566, comprising:

| NUMBER NEEDED FOR A FULL TRIAL
We calculated that a total sample size of 126 participants, with 63 per group, will be needed for an effect of 0.5 point difference on the behavioural intention subscale of the APEND between groups (SD = 1) to be detected in a full trial (α = 5% and power = 80% We did not find any differences in intention to seek help for memory problems between the 2 groups; however, the study was not powered to evaluate efficacy or detect differences between groups. We recruited our predefined sample of BACe patients on target although response rates to enrol were low. Only 8% (65/787) of those contacted by GP staff responded to the letter inviting them to enter the study. However, the large majority of those who expressed interest enrolled and completed the follow-up phase. The barriers to recruiting BME in health research are not clearly understood but appear to be multifactorial and multilevel, and begin even before the actual initiation of the research study. 21 Regulations in the US have helped with increasing the number of minority ethnic participants included in trials. 22 In the UK where there is no such legislation, the participation of ethnic minorities in trials is lagging far behind American trials. 23 We also met our target number of GP practices. consultations for memory problems did not translate into a significant increase in referral to memory clinic, 18 thus, suggesting that the obstacles to entering dementia services may reside at service provider level rather than patient level.

| LIMITATIONS OF THE STUDY
We were unable for ethical reasons to have any information of those potential participants who did not agree to be approached. Nearly 80% of the people in the intervention group said they read the leaflet and letter in part or fully, but we do not know whether they did so and as is the nature of a feasibility study whether it changed outcomes. In addition, the voucher incentive while a normal part of such research may have contributed to the high number of patients that reportedly read the leaflet. While we assumed that both groups were the same at baseline before receiving the leaflet, we do not know whether this is true in terms of intentions. A full efficacy trial should include a method of assessing how well patients engage with the intervention.
Other recruitment channels may also be advisable as recruiting only via GP practices may be affected by doctor-patient relationships when the relationship is weak or broken, because doctors play an important role in patients decision making about research trial participation. 25 Furthermore, the APEND questionnaire is a relatively new scale, developed for UK-based South Asian people, which may need to be adapted to this study population. Finally, the questionnaires were completed during an interview with a member of the research team who was aware of participants' study group allocation. Therefore, there was a potential for observer bias 26 and social desirability bias 27 in that participants may have responded in a manner that they perceived would be viewed favourably by the interviewer.  S. Adelman assisted with writing the article.